Synchronous uterine and bladder cancers detected in urine and vaginal samples by cytology.

Novel diagnostics for uterine cancer are urgently needed to reduce the burden of invasive testing for the majority of healthy women with postmenopausal bleeding. We have previously shown that uterine cancer cells can be detected by cytology in urine and vaginal samples with high diagnostic accuracy. Here, we demonstrate its potential to distinguish malignant cells of different aetiologies in the same urogenital biofluid sample according to their distinctive morphology and immunoprofiles. Synchronous tumours of the urogenital tract are uncommon but can cause diagnostic confusion, delays and poor outcomes. A 79-year-old woman presented to accident and emergency with postmenopausal bleeding. Voided urine and Delphi screener-collected vaginal samples were assessed by cytology and immunocytochemistry. Two malignant cell populations with distinct morphology and immunophenotypes consistent with synchronous uterine and urothelial tumours were identified. Subsequent routine diagnostics confirmed concurrent uterine carcinosarcoma and high-grade urothelial carcinoma of the bladder. This case demonstrates that cytology and adjunctive immunocytochemistry can simultaneously identify and phenotype cancers of different aetiologies from a single urogenital biofluid sample. This can help rationalise diagnostic pathways in complex, unusual cases of dual urogenital primaries.

DEveloping Tests for Endometrial Cancer deTection (DETECT): protocol for a diagnostic accuracy study of urine and vaginal samples for the detection of endometrial cancer by cytology in women with postmenopausal bleeding.

INTRODUCTION: Postmenopausal bleeding (PMB), the red flag symptom for endometrial cancer, triggers urgent investigation by transvaginal ultrasound scan, hysteroscopy and/or endometrial biopsy. These investigations are costly, invasive and often painful or distressing for women. In a pilot study, we found that voided urine and non-invasive vaginal samples from women with endometrial cancer contain malignant cells that can be identified by cytology. The aim of the DEveloping Tests for Endometrial Cancer deTection (DETECT) Study is to determine the diagnostic test accuracy of urine and vaginal cytology for endometrial cancer detection in women with PMB. METHODS AND ANALYSIS: This is a multicentre diagnostic accuracy study of women referred to secondary care with PMB. Eligible women will be asked to provide a self-collected voided urine sample and a vaginal sample collected with a Delphi screener before routine clinical procedures. Pairs of specialist cytologists, blinded to participant cancer status, will assess and classify samples independently, with differences settled by consensus review or involving a third cytologist. Results will be compared with clinical outcomes from standard diagnostic tests. A sample size of 2000 women will have 80% power to establish a sensitivity of vaginal samples for endometrial cancer detection by cytology of ≥85%±7%, assuming 5% endometrial cancer prevalence. The primary objective is to determine the diagnostic accuracy of urogenital samples for endometrial cancer detection by cytology. Secondary objectives include the acceptability of urine and vaginal sampling to women. ETHICS AND DISSEMINATION: This study has been approved by the North West-Greater Manchester West Research Ethics Committee (16/NW/0660) and the Health Research Authority. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via charity websites. TRIAL REGISTRATION NUMBER: ISRCTN58863784.

Diagnostic accuracy of cytology for the detection of endometrial cancer in urine and vaginal samples.

Postmenopausal bleeding triggers urgent investigation by sequential invasive tests that are avoidable for the 90-95% of women who do not have endometrial cancer. A simple, non-invasive tool that accurately identifies cancer and safely reassures healthy women could transform patient care. Here we report, in a cross-sectional diagnostic accuracy study of 103 women with known cancer and 113 with unexplained postmenopausal bleeding, that urine and vaginal cytology has a combined sensitivity of 91.7% (95% CI 85.0%, 96.1%) and specificity of 88.8% (81.2%, 94.1%) for gynecological cancer detection. Cytology identifies 91 endometrial, two fallopian tube and one cervical cancer from 103 known cancer cases. In women with unexplained postmenopausal bleeding, cytology identifies all four endometrial cancers and three others (cervical, ovarian and bladder), for a 12/107 (11.2%) false positive rate. We show proof-of-principle that endometrial cancer can be detected in urine and vaginal fluid. Prospective validation of these findings will support incorporation of this non-invasive test into clinical practice.

Urinary Biomarkers and Their Potential for the Non-Invasive Detection of Endometrial Cancer.

Endometrial cancer is the most common malignancy of the female genital tract and its incidence is rising in parallel with the mounting prevalence of obesity. Early diagnosis has great potential to improve outcomes as treatment can be curative, especially for early stage disease. Current tests and procedures for diagnosis are limited by insufficient accuracy in some and unacceptable levels of invasiveness and discomfort in others. There has, therefore, been a growing interest in the search for sensitive and specific biomarkers for endometrial cancer detection based on non-invasive sampling methodologies. Urine, the prototype non-invasive sample, is attractive for biomarker discovery as it is easily accessible and can be collected repeatedly and in quantity. Identification of urinary biomarkers for endometrial cancer detection relies on the excretion of systemic biomarkers by the kidneys or urinary contamination by biomarkers shed from the uterus. In this review, we present the current standing of the search for endometrial cancer urinary biomarkers based on cytology, genomic, transcriptomic, proteomic, and metabolomic platforms. We summarize the biomarker candidates and highlight the challenges inherent in urinary biomarker discovery. We review the various technologies with promise for biomarker detection and assess these novel approaches for endometrial cancer biomarker research.

The proportion of endometrial tumours associated with Lynch syndrome (PETALS): A prospective cross-sectional study.

BACKGROUND: Lynch syndrome (LS) predisposes to endometrial cancer (EC), colorectal cancer, and other cancers through inherited pathogenic variants affecting mismatch-repair (MMR) genes. Diagnosing LS in women with EC can reduce subsequent cancer mortality through colonoscopic surveillance and aspirin chemoprevention; it also enables cascade testing of relatives. A growing consensus supports LS screening in EC; however, the expected proportion of test positives, and optimal testing strategy is uncertain. Previous studies from insurance-based healthcare systems were limited by narrow selection criteria, failure to apply reference standard tests consistently, and poor conversion to definitive testing. The aim of this study was to establish the prevalence of LS and the diagnostic accuracy of LS testing strategies in an unselected EC population. METHODS AND FINDINGS: This was a prospective cross-sectional study carried out at a large United Kingdom gynaecological cancer centre between October 2015 and January 2017. Women diagnosed with EC or atypical hyperplasia (AH) were offered LS testing. Tumours underwent MMR immunohistochemistry (IHC), microsatellite instability (MSI), and targeted MLH1-methylation testing. Women <50 years, with strong family histories and/or indicative tumour molecular features, underwent MMR germline sequencing. Somatic MMR sequencing was performed when indicative molecular features were unexplained by LS or MLH1-hypermethylation. The main outcome measures were the prevalence of LS in an unselected EC population and the diagnostic accuracy of clinical and tumour testing strategies for risk stratifying women with EC for MMR germline sequencing. In total, 500 women participated in the study; only 2 (<1%) declined. Germline sequencing was indicated and conducted for 136 and 135 women, respectively. A total of 16/500 women (3.2%, 95% CI 1.8% to 5.1%) had LS, and 11 more (2.2%) had MMR variants of uncertain significance. Restricting testing to age <50 years, indicative family history (revised Bethesda guidelines or Amsterdam II criteria) or endometrioid histology alone would have missed 9/16 (56%), 8/13 (62%) or 9/13 (69%), and 5/16 (31%) cases of LS, respectively. In total 132/500 tumours were MMR deficient by IHC of which 83/132 (63%) had MLH1-hypermethylation, and 16/49 (33%) of the remaining patients had LS (16/132 with MMR deficiency, 12%). MMR-IHC with targeted MLH1-methylation testing was more discriminatory for LS than MSI with targeted methylation testing, with 100% versus 56.3% (16/16 versus 9/16) sensitivity (p = 0.016) and equal 97.5% (468/484) specificity; 64% MSI-H and 73% MMR deficient tumours unexplained by LS or MLH1-hypermethylation had somatic MMR mutations. The main limitation of the study was failure to conduct MMR germline sequencing for the whole study population, which means that the sensitivity and specificity of tumour triage strategies for LS detection may be overestimated, although the risk of LS in women with no clinical or tumour predictors is expected to be extremely low. CONCLUSIONS: In this study, we observed that age, family history, and histology are imprecise clinical correlates of LS-EC. IHC outperformed MSI for tumour triage and reliably identified both germline and somatic MMR mutations. The 3.2% proportion of LS-EC is similar to colorectal cancer, supporting unselected screening of EC for LS.

Detecting Endometrial Cancer by Blood Spectroscopy: A Diagnostic Cross-Sectional Study.

Endometrial cancer is the sixth most common cancer in women, with a rising incidence worldwide. Current approaches for the diagnosis and screening of endometrial cancer are invasive, expensive or of moderate diagnostic accuracy, limiting their clinical utility. There is a need for cost-effective and minimally invasive approaches to facilitate the early detection and timely management of endometrial cancer. We analysed blood plasma samples in a cross-sectional diagnostic accuracy study of women with endometrial cancer (n = 342), its precursor lesion atypical hyperplasia (n = 68) and healthy controls (n = 242, total n = 652) using attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy and machine learning algorithms. We show that blood-based infrared spectroscopy has the potential to detect endometrial cancer with 87% sensitivity and 78% specificity. Its accuracy is highest for Type I endometrial cancer, the most common subtype, and for atypical hyperplasia, with sensitivities of 91% and 100%, and specificities of 81% and 88%, respectively. Our large-cohort study shows that a simple blood test could enable the early detection of endometrial cancer of all stages in symptomatic women and provide the basis of a screening tool in high-risk groups. Such a test has the potential not only to differentially diagnose endometrial cancer but also to detect its precursor lesion atypical hyperplasia-the early recognition of which may allow fertility sparing management and cancer prevention.

Barrier agents for adhesion prevention after gynaecological surgery.

BACKGROUND: Pelvic adhesions can form secondary to inflammation, endometriosis, or surgical trauma. Strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene, and fibrin or collagen sheets between pelvic structures. OBJECTIVES: To evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth, and postoperative adhesions in women of reproductive age. SEARCH METHODS: We searched the following databases in August 2019: the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), Epistemonikos, and trial registries. We searched reference lists of relevant papers, conference proceedings, and grey literature sources. We contacted pharmaceutical companies for information and handsearched relevant journals and conference abstracts. SELECTION CRITERIA: Randomised controlled trials (RCTs) on the use of barrier agents compared with other barrier agents, placebo, or no treatment for prevention of adhesions in women undergoing gynaecological surgery. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for eligibility and risk of bias and extracted data. We calculated odds ratios (ORs) or mean differences (MDs) with 95% confidence intervals (CIs) using a fixed-effect model. We assessed the overall quality of the evidence using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods. MAIN RESULTS: We included 19 RCTs (1316 women). Seven RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (11 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (seven RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT), and mixed gynaecological surgery (one RCT). The sole indication for surgery in three of the RCTs was infertility. Thirteen RCTs reported commercial funding; the rest did not state their source of funding. No studies reported our primary outcomes of pelvic pain and live birth rate. Oxidised regenerated cellulose versus no treatment at laparoscopy or laparotomy (13 RCTs) At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose at laparoscopy reduced the incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, 3 RCTs, 360 participants; I² = 75%; very low-quality evidence) or of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, 3 RCTs, 100 participants; I² = 36%; very low-quality evidence). At second-look laparoscopy, we are uncertain whether oxidised regenerated cellulose affected the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, 1 RCT, 271 participants; very low-quality evidence). However, the incidence of re-formed adhesions may have been reduced in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, 6 RCTs, 554 participants; I² = 41%; low-quality evidence). No studies reported results on pelvic pain, live birth rate, adhesion score, or clinical pregnancy rate. Expanded polytetrafluoroethylene versus oxidised regenerated cellulose at gynaecological surgery (two RCTs) We are uncertain whether expanded polytetrafluoroethylene reduced the incidence of de novo adhesions at second-look laparoscopy (OR 0.93, 95% CI 0.26 to 3.41, 38 participants; very low-quality evidence). We are also uncertain whether expanded polytetrafluoroethylene resulted in a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants; very low-quality evidence) or a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants; very low-quality evidence) when compared with oxidised regenerated cellulose. No studies reported results regarding pelvic pain, live birth rate, or clinical pregnancy rate. Collagen membrane with polyethylene glycol and glycerol versus no treatment at gynaecological surgery (one RCT) Evidence suggests that collagen membrane with polyethylene glycol and glycerol may reduce the incidence of adhesions at second-look laparoscopy (OR 0.04, 95% CI 0.00 to 0.77, 47 participants; low-quality evidence). We are uncertain whether collagen membrane with polyethylene glycol and glycerol improved clinical pregnancy rate (OR 5.69, 95% CI 1.38 to 23.48, 39 participants; very low-quality evidence). One study reported adhesion scores but reported them as median scores rather than mean scores (median score 0.8 in the treatment group vs median score 1.2 in the control group) and therefore could not be included in the meta-analysis. The reported P value was 0.230, and no evidence suggests a difference between treatment and control groups. No studies reported results regarding pelvic pain or live birth rate. In total, 15 of the 19 RCTs included in this review reported adverse events. No events directly attributed to adhesion agents were reported. AUTHORS' CONCLUSIONS: We found no evidence on the effects of barrier agents used during pelvic surgery on pelvic pain or live birth rate in women of reproductive age because no trial reported these outcomes. It is difficult to draw credible conclusions due to lack of evidence and the low quality of included studies. Given this caveat, low-quality evidence suggests that collagen membrane with polyethylene glycol plus glycerol may be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. Low-quality evidence also shows that oxidised regenerated cellulose may reduce the incidence of re-formation of adhesions when compared with no treatment at laparotomy. It is not possible to draw conclusions on the relative effectiveness of these interventions due to lack of evidence. No adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. Common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.

Correction to: Recognizing Gynecological Cancer in Primary Care: Risk Factors, Red Flags, and Referrals.

The article "Recognizing Gynecological Cancer in Primary Care: Risk Factors, Red Flags, and Referrals", written by Garth Funston, Helena O'Flynn, Neil A. J. Ryan, Willie Hamilton, Emma J. Crosbie was originally published electronically on the publisher's internet portal (currently Springer-Link) on March 07, 2018 without open access.

Recognizing Gynecological Cancer in Primary Care: Risk Factors, Red Flags, and Referrals.

Early diagnosis of symptomatic gynecological cancer is likely to improve patient outcomes, including survival. The primary care practitioner has a key role to play in this-they must recognize the symptoms and signs of gynecological cancer and make prompt evidence-based decisions regarding further investigation and referral. However, this is often difficult as many of the symptoms of gynecological cancers are nonspecific and are more likely to be caused by benign rather than malignant disease. As primary care is generally the first point of patient contact, those working in this setting usually encounter cancer patients at an earlier, and possibly less symptomatic, stage than practitioners in secondary care. Despite these challenges, research has improved our understanding of the symptoms patients present to primary care with, and a range of tests and referral pathways now exist in the UK and other countries to aid early diagnosis. Primary care practitioners can also play a key role in gynecological cancer prevention. A significant proportion of gynecological cancer is preventable either through lifestyle changes such as weight loss, or, for cervical cancer, vaccination and/or engagement with screening programs. Primary care provides an excellent opportunity to discuss cancer risk with patients and to promote risk reduction strategies and lifestyle change. In this article, the first in a series discussing cancer detection in primary care, we concentrate on gynecological cancer and focus on the three most common forms that a primary care practitioner is likely to encounter: ovarian, endometrial, and cervical cancer. We outline key risk factors, briefly discuss prevention and screening strategies, and offer practical guidance on the recognition of symptoms and signs and the investigation and referral of women with suspected cancer. While this article is written from a UK primary care perspective, much of what is discussed will be of relevance to those working in other healthcare systems.

Pain relief for outpatient hysteroscopy.

BACKGROUND: Hysteroscopy is increasingly performed in an outpatient setting. Pain is the primary reason for abandonment of procedure or incomplete assessment. There is no consensus upon routine use of analgesia during hysteroscopy. OBJECTIVES: To assess the effectiveness and safety of pharmacological interventions for pain relief in women undergoing outpatient hysteroscopy, compared with placebo, no treatment or other pharmacological therapies. SEARCH METHODS: In September 2016 we searched the Cochrane Gynaecology and Fertility (CGF) Trials Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two trials registers (ClinicalTrials.gov and WHO ICTRP), together with reference checking and contact with study authors and experts. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing use of pharmacological interventions with other pharmacological interventions and pharmacological interventions versus placebo or no treatment. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was mean pain score. MAIN RESULTS: We included 32 RCTS (3304 participants), of which only 19 reported data suitable for analysis. Most studies were at unclear or high risk of bias in most of the domains assessed. The evidence was low or very low quality, mainly due to risk of bias and imprecision. Baseline pain scores were relatively low in all groups. Analgesic versus placebo or no treatment Local anaesthetics Local anaesthetics reduced mean pain scores during the procedure [(SMD) -0.29, 95% CI -0.39 to -0.19, 10 RCTs, 1496 women, I2 = 80%, low-quality evidence)] and within 30 minutes (SMD 0.50, 95% CI -0.67 to -0.33, 5 RCTs, 545 women, I2 = 43%, low-quality evidence). This translates to a difference of up to 7 mm on a 0-10 cm visual analogue scale (VAS) during the procedure and up to 13 mm within 30 minutes, which is unlikely to be clinically meaningful. There was no clear evidence of a difference between the groups in mean pain scores after > 30 minutes (SMD -0.11, 95% CI -0.30 to 0.07, 4 RCTs, 450 women, I2 = 0%, low-quality evidence), or in rates of vasovagal reactions (OR 0.70, 95% CI 0.43 to 1.13, 8 RCTs, 1309 women, I2 = 66%, very low-quality evidence). There was insufficient evidence to determine whether there was a difference in rates of non-pelvic pain (OR 1.76, 95% CI 0.53 to 5.80, 1 RCT, 99 women, very low-quality evidence). Nonsteroidal anti-inflammatory drugs (NSAIDs) There was insufficient evidence to determine whether there was a difference between the groups in mean pain scores during the procedure (SMD -0.18, 95% CI -0.35 to 0.00, 3 RCTs, 521 women, I2 = 81%, low-quality evidence). Pain scores were lower in the NSAIDs group within 30 minutes (SMD -0.25, 95% CI -0.46 to -0.04, 2 RCTs, 340 women, I2=29%, low-quality evidence) and at over 30 minutes (SMD -0.27, 95% CI -0.49 to -0.05, 2 RCTs, 321 women, I2 = 78%, low-quality evidence). This equates to maximum differences of under 7.5 mm on a 0-10 cm scale, which are unlikely to be clinically significant. One RCT (181 women) reported adverse events: there was insufficient evidence to determine whether there was a difference between the groups in vasovagal reactions (OR 0.76, 95% CI 0.20 to 2.94, very low-quality evidence). For other reported adverse events (non pelvic pain and allergic reactions) evidence was lacking. Opioids One RCT utilised sublingual buprenorphine and one utilised oral tramadol. Data on pain scores during the procedure were unsuitable for pooling due to inconsistency. Tramadol was associated with a benefit of up to 22 mm on a 0-10 cm scale (SMD -0.76, 95% CI -1.10 to -0.42, 1 RCT, 140 women). However, the effect estimate for this outcome for sublingual opioids did not support a benefit from the intervention (SMD 0.08, 95% CI -0.22 to 0.39, 164 women). Compared with placebo, the pain score within 30 minutes of the procedure was reduced in the tramadol group, with a difference of up to 17mm on a 0-10cm scale (SMD -0.57, 95% CI -0.91 to -0.23 , 1 RCT, 140 women, low-quality evidence. There was no clear evidence of a difference between the tramadol and placebo groups at over 30 minutes (SMD -0.17, 95% CI -0.51 to 0.16, 1 RCT, 140 women, low-quality evidence). Nausea and vomiting occurred in 39% of the buprenorphine group, and in none of the placebo group (OR 107.55, 95% CI 6.44 to 1796.46) Analgesic versus any other analgesic Some comparisons did not report pain scores at all time frames of interest, and none reported data on adverse events. One RCT (84 women) compared local intracervical anaesthesia versus combined intracervical and paracervical anaesthesia. Pain scores were higher in the group with local intracervical anaesthesia during the procedure (SMD 4.27, 95% CI 3.49 to 5.06, very low-quality evidence), within 30 minutes (SMD 1.55, 95% CI 1.06 to 2.05, very low-quality evidence) and at more than 30 minutes (SMD 3.47, 95% CI 2.78 to 4.15, very low-quality evidence). This translates to a possible benefit in the combined group of up to 12 mm on a 0-10 cm scale during the procedure. Benefits at longer follow-up were smaller. One RCT compared antispasmodic + NSAID versus local paracervical anaesthesia. Pain scores were lower in the NSAID group than in the local anaesthesia group (during procedure: SMD -1.40, 95% CI -1.90 to -0.91; >30 minutes after procedure: SMD -0.87, 95% CI -1.33 to -0.41; 80 women, very low-quality evidence). This suggests a possible benefit of during the procedure of up to 23 mm on a 0-10 VAS scale and up to 11 mm >30 minutes after the procedure. Other comparisons included local intracervical anaesthesia versus combined intracervical, paracervical and topical anaesthesia, and opioid versus NSAIDs. Findings were inconclusive. AUTHORS' CONCLUSIONS: There was no consistent good-quality evidence of a clinically meaningful difference in safety or effectiveness between different types of pain relief compared with each other or with placebo or no treatment in women undergoing outpatient hysteroscopy.

Pain relief in hysterosalpingography.

BACKGROUND: Hysterosalpingography (HSG) is a method of testing for tubal patency. However, women struggle to tolerate the procedure, as it is associated with some discomfort. Various pharmacological strategies are available that may reduce pain during the procedure, though there is no consensus as to the best method. OBJECTIVES: To compare the effectiveness of different types of pharmacological interventions for pain relief in women undergoing HSG for investigation of subfertility. SEARCH METHODS: This review has drawn on the search strategy developed for the Cochrane Menstrual Disorders and Subfertility Group (MDSG). We searched the following databases to 15 April 2015: MDSG Specialised Register, CENTRAL, MEDLINE, EMBASE, CINAHL and PsycINFO. SELECTION CRITERIA: All identified randomised controlled trials investigating pharmacological interventions for pain relief during HSG were investigated for selection. DATA COLLECTION AND ANALYSIS: Four review authors independently extracted data. We combined data to calculate mean differences (MDs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using the I² statistic. We assessed the overall quality of the evidence for the main comparisons using GRADE methods. MAIN RESULTS: The search identified 23 trials (1272 women) that were eligible for inclusion into the study. Oral opioid analgesia versus placebo/no treatmentThere was no evidence of effect for oral opioid analgesia in reducing pain during the procedure (MD -0.91, 95% CI -1.88 to 0.06, 1 study, n = 128, low quality evidence) or more than 30 minutes after the procedure (MD -0.99, 95% CI -1.75 to -0.23, 1 study, n = 128, moderate quality evidence)No studies reported on the effect of oral opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes after the procedureThere was insufficient evidence to reach conclusions regarding adverse effects. Intravenous opioid analgesia versus placebo/no treatmentThere was evidence that intravenous opioids may improve pain relief during the procedure compared to no treatment (MD -3.53, 95% CI -4.29 to -2.77, 1 study, n = 62, moderate quality evidence)No studies reported on the effect of intravenous opioid analgesia, when taken prior to the procedure, in reducing pain within 30 minutes and more than 30 minutes after the procedureIn terms of adverse effects, one trial reported 1/32 participants had apnoea with intravenous remifentanil. Recovery time was nearly 4 minutes longer in the remifentanil group compared to the control. Oral non-opioid analgesia versus placebo/no treatmentThere was no evidence of effect for oral non-opioid analgesia in reducing pain during the procedure (MD -0.13, 95% CI -0.48 to 0.23, 3 studies, n = 133, I² = 61%, low quality evidence), less than 30 minutes after the procedure (MD -0.30, 95% CI -1.03 to 0.43, 2 studies, n = 45, I² = 97%, very low quality evidence), or more than 30 minutes after the procedure (MD -0.36, 95% CI -1.06 to 0.34, 3 studies, n = 133, I² = 58%, low quality evidence).There was insufficient evidence to reach conclusions regarding adverse effects. Topical anaesthesia versus placebo/no treatmentThere was evidence that topical anaesthetics may reduce pain during the procedure (MD -0.63, 95% CI -1.06 to -0.19, 9 studies, n = 613, I² = 66%, low quality evidence).There was no evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD 0.42, 95% CI -0.03 to 0.86, 5 studies, n = 373, I² = 59%, very low quality evidence).There was evidence of effect for topical anaesthesia, when applied prior to the procedure, in reducing pain more than 30 minutes after the procedure (MD -1.38, 95% CI -3.44 to -0.68, 2 studies, n = 166, I² = 92%, very low quality evidence).There was insufficient evidence to reach conclusions regarding adverse effects. Locally injected anaesthesia versus placebo/no treatmentThere was evidence of effect that locally injected anaesthetic can reduce pain during the procedure (MD -1.31, 95% CI -1.55 to -1.07, 2 studies, n = 125, I² = 0%, very low quality evidence).There was no evidence of effect for locally injected anaesthesia, when applied prior to the procedure, in reducing pain less than 30 minutes after the procedure (MD -1.31, 95% CI -2.14 to -0.49, 2 studies, n = 125, I² = 46%, low quality evidence).No studies were included into the analysis of the effect of locally injected anaesthesia, when injected prior to the procedure, in reducing pain more than 30 minutes after the procedure.There was insufficient evidence to reach conclusions regarding adverse effects. Any analgesic versus any other analgesicThere was no evidence of a difference between the groups when oral non-opioid analgesia was compared to opioid analgesia for pain relief during the procedure (MD 1.10, 95% CI -0.26 to 2.46, 1 study, n = 91, low quality evidence); less than 30 minutes following the procedure (MD -0.30, 95% CI -1.00 to 0.40, 1 study, n = 91, low quality evidence); and more than 30 minutes following the procedure (MD -0.60, 95% CI -1.56 to 0.36, 1 study, n = 91, low quality evidence). Topical anaesthetics were found to be more effective than paracervical block for pain relief during HSG (MD -2.73, 95% CI -3.86 to -1.60, 1 study, n = 20, moderate quality evidence). This benefit did not extend to within 30 minutes following HSG (MD -1.03, 95% CI -2.52 to 0.46, 1 study, n = 20, low quality evidence); or 30 minutes or more after HSG (MD 0.31, 95% CI -0.87 to 1.49, 1 study, n = 20, low quality evidence).There was insufficient evidence to reach conclusions regarding adverse effects. AUTHORS' CONCLUSIONS: Topical anaesthetic applied before the procedure may be associated with effective pain relief during HSG, though the quality of this evidence is low. Intravenous opioids may also be effective in pain relief, though this must be weighed against their side effects and their effects on the recovery time. There is insufficient evidence to draw conclusions on the efficacy of other analgesics for HSG, or to reach any other conclusions regarding adverse effects.

Laparoscopic entry techniques.

BACKGROUND: Laparoscopy is a common procedure in many surgical specialities. Complications arising from laparoscopy are often related to initial entry into the abdomen. Life-threatening complications include injury to viscera e.g. the bowel or bladder, or to vasculature e.g. major abdominal and anterior abdominal wall vessels. Minor complications can also occur, such as postoperative wound infection, subcutaneous emphysema, and extraperitoneal insufflation. There is no clear consensus as to the optimal method of laparoscopic entry into the peritoneal cavity. OBJECTIVES: To evaluate the benefits and risks of different laparoscopic entry techniques in gynaecological and non-gynaecological surgery. SEARCH METHODS: This updated review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group. In addition, MEDLINE, EMBASE, CENTRAL and PsycINFO were searched through to September 2014. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in which one laparoscopic entry technique was compared with another. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed risk of bias, and extracted data. We expressed findings as Peto odds ratios (Peto ORs) with 95% confidence intervals (CIs). We assessed statistical heterogeneity using the I² statistic. We assessed the overall quality of evidence for the main comparisons using GRADE methods. MAIN RESULTS: The review included 46 RCTs including three multi-arm trials (7389 participants) and evaluated 13 laparoscopic entry techniques. Overall there was no evidence of advantage using any single technique for preventing major vascular or visceral complications. The evidence was generally of very low quality; the main limitations were imprecision and poor reporting of study methods. Open-entry versus closed-entry There was no evidence of a difference between the groups for vascular (Peto OR 0.14, 95% CI 0.00 to 6.82, three RCTs, n = 795, I(2) = n/a; very low quality evidence) or visceral injury (Peto OR 0.61, 95% CI 0.06 to 6.08, three RCTs, n = 795, I(2) = 0%; very low quality evidence). There was a lower risk of failed entry in the open-entry group (Peto OR 0.16, 95% CI 0.04 to 0.63, n = 665, two RCTs, I(2) = 0%; very low quality evidence). This suggests that for every 1000 patients operated on, 31 patients in the closed-entry group will have failed entry compared to between 1 to 20 patients in the open-entry group. No events were reported in any of the studies for mortality, gas embolism or solid organ injury. Direct trocar versus Veress needle entry There was a lower risk of vascular injury in the direct trocar group (Peto OR 0.13, 95% CI 0.03 to 0.66, five RCTs, n = 1522, I(2) = 0%; low quality evidence) and failed entry (Peto OR 0.21, 95% CI 0.14 to 0.30, seven RCTs, n = 3104; I ²= 0%; moderate quality evidence). This suggests that for every 1000 patients operated on, 8 patients in the Veress needle group will experience vascular injury compared to between 0 to 5 patients in the direct trocar group; and that 64 patients in the Veress needle group will experience failed entry compared to between 10 to 20 patients in the direct trocar group. The vascular injury significance is sensitive to choice of statistical analysis and may be unreliable. There was no evidence of a difference between the groups for visceral (Peto OR 1.02, 95% CI 0.06 to 16.24, four RCTs, n = 1438, I(2) = 49%; very low quality evidence) or solid organ injury (Peto OR 0.16, 95% Cl 0.01 to 2.53, two RCTs, n = 998, I(2) = n/a; very low quality evidence). No events were recorded for mortality or gas embolism. Direct vision entry versus Veress needle entry There was no evidence of a difference between the groups in the rates of visceral injury (Peto OR 0.15, 95% CI 0.01 to 2.34, one RCT, n = 194; very low quality evidence). Other primary outcomes were not reported. Direct vision entry versus open-entry There was no evidence of a difference between the groups in the rates of visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.50, two RCTs, n = 392; low quality evidence), solid organ injury (Peto OR 6.16, 95% CI 0.12 to 316.67, one RCT, n = 60, I(2) = n/a; very low quality evidence), or failed entry (Peto OR 0.40, 95% CI 0.04 to 4.09, one RCT, n = 60; low quality evidence). Vascular injury was reported, however no events occurred. Our other primary outcomes were not reported. Radially expanding (STEP) trocars versus non-expanding trocars There was no evidence of a difference between the groups for vascular injury (Peto OR 0.24, 95% Cl 0.05 to 1.21, two RCTs, n = 331, I(2) = 0%; low quality evidence), visceral injury (Peto OR 0.13, 95% CI 0.00 to 6.37, two RCTs, n = 331, I(2) = n/a; low quality evidence), or solid organ injury (Peto OR 1.05, 95% CI 0.07 to 16.91, one RCT, n = 244; very low quality evidence). Other primary outcomes were not reported. Comparisons of other laparoscopic entry techniquesThere was a higher risk of failed entry in the group in which the abdominal wall was lifted before Veress needle insertion than in the not-lifted group (Peto OR 4.44, 95% CI 2.16 to 9.13, one RCT, n = 150; very low quality evidence). There was no evidence of a difference between the groups in rates of visceral injury or extraperitoneal insufflation. The studies had small numbers and excluded many patients with previous abdominal surgery, and women with a raised body mass index. These patients may have unusually high complication rates. AUTHORS' CONCLUSIONS: Overall, there is insufficient evidence to recommend one laparoscopic entry technique over another.An open-entry technique is associated with a reduction in failed entry when compared to a closed-entry technique, with no evidence of a difference in the incidence of visceral or vascular injury.An advantage of direct trocar entry over Veress needle entry was noted for failed entry and vascular injury. The evidence was generally of very low quality with small numbers of participants in most studies; our findings should be interpreted with caution.

Barrier agents for adhesion prevention after gynaecological surgery.

BACKGROUND: Pelvic adhesions can form as a result of inflammation, endometriosis or surgical trauma. During pelvic surgery, strategies to reduce pelvic adhesion formation include placing barrier agents such as oxidised regenerated cellulose, polytetrafluoroethylene or fibrin sheets between the pelvic structures. OBJECTIVES: To evaluate the effects of barrier agents used during pelvic surgery on rates of pain, live birth and postoperative adhesions in women of reproductive age. SEARCH METHODS: We searched the following databases in February 2015: the Menstrual Disorders and Subfertility Group (MDSG) Specialised Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL) and trial registries. We handsearched relevant journals, conference proceedings and grey literature sources and we contacted pharmaceutical companies for information. SELECTION CRITERIA: Randomised controlled trials (RCTs) of the use of barrier agents compared with other barrier agents, placebo or no treatment for the prevention of adhesions in women undergoing gynaecological surgery. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for eligibility and risk of bias and extracted the data. We calculated odds ratios (ORs) or mean differences (MD) with 95% confidence intervals (CIs) using a fixed effect model. The overall quality of the evidence was assessed using GRADE (Grades of Recommendation, Assessment, Development and Evaluation) methods. MAIN RESULTS: Eighteen RCTs (1262 women) were included. Six RCTs randomised women; the remainder randomised pelvic organs. Laparoscopy (eight RCTs) and laparotomy (10 RCTs) were the primary surgical techniques. Indications for surgery included myomectomy (six RCTs), ovarian surgery (five RCTs), pelvic adhesions (five RCTs), endometriosis (one RCT) and mixed (one RCT). The sole indication for surgery in three of the RCTs was infertility. Twelve RCTs reported commercial funding; the rest did not state their source of funding.No studies reported either of our primary outcomes of pelvic pain and live birth. Oxidised regenerated cellulose (Interceed) versus no treatment at laparoscopy or laparotomy (13 RCTs)At second-look laparoscopy oxidised regenerated cellulose at laparoscopy was associated with reduced incidence of de novo adhesions (OR 0.50, 95% CI 0.30 to 0.83, three RCTs, 360 participants, I(2) = 75%, very low-quality evidence) and of re-formed adhesions (OR 0.17, 95% CI 0.07 to 0.41, three RCTs, 100 participants, I(2) = 36%, low quality evidence).At second-look laparoscopy no evidence was found of any difference between the groups in the incidence of de novo adhesions after laparotomy (OR 0.72, 95% CI 0.42 to 1.25, one RCT, 271 participants, I(2) = 41%, low-quality evidence). However, the incidence of re-formed adhesions was lower in the intervention group (OR 0.38, 95% CI 0.27 to 0.55, six RCTs, 554 participants, moderate-quality evidence). Expanded polytetrafluoroethylene (Gore-Tex) versus no treatment at gynaecological surgery (one RCT) The evidence suggested that at second-look laparoscopy expanded polytetrafluoroethylene was associated with a reduction in new adhesion formation (OR 0.17, 95% CI 0.03 to 0.94, one RCT, 42 participants, low-quality evidence). Expanded polytetrafluoroethylene (Gore-Tex) versus oxidised regenerated cellulose (Interceed) at gynaecological surgery (two RCTs)One RCT found no difference between the groups at second-look laparoscopy in the incidence of de novo adhesions (OR 0.93, 95% CI 0.26 to 3.41, 38 participants, very low-quality evidence). A second RCT suggested that the expanded polytetrafluoroethylene group had a lower adhesion score (out of 11) (MD -3.79, 95% CI -5.12 to -2.46, 62 participants, very low-quality evidence) and a lower risk of re-formed adhesions (OR 0.13, 95% CI 0.02 to 0.80, 23 participants, very low-quality evidence). This last finding was sensitive to choice of effect estimate and no longer suggested a difference between the groups when a risk ratio was calculated (RR 0.36, 95% CI 0.13 to 1.01). Sodium hyaluronate and carboxymethylcellulose (Seprafilm) versus no treatment at gynaecological surgery (one RCT)Sodium hyaluronate and carboxymethylcellulose was associated with a lower adhesion score (out of 4) at second-look laparoscopy (MD 0.49, 95% CI 0.53 to 0.45, one RCT, 127 participants, moderate-quality evidence). Fibrin sheet versus no treatment at laparoscopic myomectomy (one RCT)There was no evidence of a difference between the groups in the incidence of de novo adhesions at second-look laparoscopy (OR 1.20, 95% CI 0.42 to 3.41, one RCT, 62 participants) or in adhesion score (out of 4) (MD 0.14, 95% CI -0.67 to 0.39, one RCT, 48 participants, low-quality evidence).Fourteen of the 18 RCTs reported adverse events. No events directly attributed to adhesion agents were reported. AUTHORS' CONCLUSIONS: We found no evidence on the effects of barrier agents used during pelvic surgery on either pain or fertility outcomes in women of reproductive age.Low quality evidence suggests that oxidised regenerated cellulose (Interceed), expanded polytetrafluoroethylene (Gore-Tex) and sodium hyaluronate with carboxymethylcellulose (Seprafilm) may all be more effective than no treatment in reducing the incidence of adhesion formation following pelvic surgery. There is no conclusive evidence on the relative effectiveness of these interventions. There is no evidence to suggest that fibrin sheet is more effective than no treatment. No adverse events directly attributed to the adhesion agents were reported. The quality of the evidence ranged from very low to moderate. The most common limitations were imprecision and poor reporting of study methods. Most studies were commercially funded, and publication bias could not be ruled out.

Fluid and pharmacological agents for adhesion prevention after gynaecological surgery.

BACKGROUND: Adhesions are fibrin bands that are a common consequence of gynaecological surgery. They are caused by various conditions including pelvic inflammatory disease and endometriosis. Adhesions are associated with considerable co-morbidity, including pelvic pain, subfertility and small bowel obstruction. Patients may require further surgery-a fact that has financial implications. OBJECTIVES: To evaluate the role of fluid and pharmacological agents used as adjuvants in preventing formation of adhesions after gynaecological surgery. SEARCH METHODS: The following databases were searched up to April 2014: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO. Studies involving hydroflotation, gel and such pharmacological agents as steroids, noxytioline, heparin, promethazine, N,O-carboxymethyl chitosan and gonadotrophin-releasing hormone agonists were evaluated. SELECTION CRITERIA: Randomised controlled trials investigating the use of fluid and pharmacological agents to prevent adhesions after gynaecological surgery. Gels were defined as fluid agents. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for eligibility, extracted data and evaluated risk of bias. Results were expressed as odds ratios (ORs), mean differences (MDs) or standard mean differences (SMDs) as appropriate, with 95% confidence intervals (CIs). MAIN RESULTS: Twenty-nine trials were included (3227 participants), and nine were excluded. One study examined pelvic pain and found no evidence of a difference between use of hydroflotation agents and no treatment. We found no evidence that any of the antiadhesion agents significantly affected the live birth rate. When gels were compared with no treatment or with hydroflotation agents at second-look laparoscopy (SLL), fewer participants who received a gel showed a worsening adhesion score when compared with those who received no treatment (OR 0.16, 95% CI 0.04 to 0.57, P value 0.005, two studies, 58 women, I(2) = 0%, moderate-quality evidence) and with those given hydroflotation agents (OR 0.28, 95% CI 0.12 to 0.66, P value 0.003, two studies, 342 women, I(2) = 0%, high-quality evidence). Participants who received steroids were less likely to have a worsening adhesion score (OR 0.27, 95% CI 0.12 to 0.58, P value 0.0008, two studies, 182 women, I(2) = 0%, low-quality evidence). Participants were less likely to have adhesions at SLL if they received a hydroflotation agent or gel than if they received no treatment (OR 0.34, 95% CI 0.22 to 0.55, P value < 0.00001, four studies, 566 participants, I(2) = 0%, high-quality evidence; OR 0.25, 95% CI 0.11 to 0.56, P value 0.0006, four studies, 134 women, I(2) = 0%, high-quality evidence, respectively). When gels were compared with hydroflotation agents, participants who received a gel were less likely to have adhesions at SLL than those who received a hydroflotation agent (OR 0.36, 95% CI 0.19 to 0.67, P value 0.001, two studies, 342 women, I(2) = 0%, high-quality evidence). No studies evaluated quality of life. In all studies apart from one, investigators stated that they were going to assess serious adverse outcomes associated with treatment agents, and no adverse effects were reported.Results suggest that for a woman with a 77% risk of developing adhesions without treatment, the risk of developing adhesions after use of a gel would be between 26% and 65%. For a woman with an 83% risk of worsening of adhesions after no treatment at initial surgery, the chance when a gel is used would be between 16% and 73%. Similarly, for hydroflotation fluids for a woman with an 84% chance of developing adhesions with no treatment, the risk of developing adhesions when hydroflotation fluid is used would be between 53% and 73%.Several of the included studies could not be included in a meta-analysis: The findings of these studies broadly agreed with the findings of the meta-analyses.The quality of the evidence, which was assessed using the GRADE approach, ranged from low to high. The main reasons for downgrading of evidence included imprecision (small sample sizes and wide confidence intervals) and poor reporting of study methods. AUTHORS' CONCLUSIONS: Gels and hydroflotation agents appear to be effective adhesion prevention agents for use during gynaecological surgery, but no evidence indicates that they improve fertility outcomes or pelvic pain, and further research is required in this area. Future studies should measure outcomes in a uniform manner, using the modified American Fertility Society (mAFS) score. Statistical findings should be reported in full.

Laparoscopic entry techniques.

BACKGROUND: Laparoscopy is a common procedure in gynaecology. Complications associated with laparoscopy are often related to entry. Life-threatening complications include injury to the bowel, bladder, major abdominal vessels, and an anterior abdominal-wall vessel. Other less serious complications can also occur, such as post-operative infection, subcutaneous emphysema and extraperitoneal insufflation. There is no clear consensus as to the optimal method of entry into the peritoneal cavity. This is an update of a Cochrane review first published in 2008. OBJECTIVES: To evaluate the benefits and risks of different laparoscopic techniques in gynaecological and non-gynaecological surgery. SEARCH METHODS: This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group. In addition, MEDLINE, EMBASE, CENTRAL and PsycINFO were searched through to February 2011. SELECTION CRITERIA: Randomised controlled trials were included when one laparoscopic entry technique was compared with another. DATA COLLECTION AND ANALYSIS: Data were extracted independently by the first three authors. Differences of opinion were registered and resolved by the fourth author. Results for each study were expressed as odds ratio (Peto OR) with 95% confidence interval (CI). MAIN RESULTS: The review included 28 randomised controlled trials with 4860 individuals undergoing laparoscopy and evaluated 14 comparisons. Overall there was no evidence of advantage using any single technique in terms of preventing major vascular or visceral complications. Using an open-entry technique compared to a Veress Needle demonstrated a reduction in the incidence of failed entry, Peto OR 0.12 (95% CI 0.02 to 0.92). There were three advantages with direct-trocar entry when compared with Veress Needle entry, in terms of lower rates of failed entry (Peto OR 0.21, 95% Cl 0.14 to 0.31), extraperitoneal insufflation (Peto OR 0.18, 95% Cl 0.13 to 0.26), and omental injury (Peto OR 0.28, 95% CI 0.14 to 0.55).There was also an advantage with radially expanding access system (STEP) trocar entry when compared with standard trocar entry, in terms of trocar site bleeding (Peto OR 0.31, 95% Cl 0.15 to 0.62). Finally, there was an advantage of not lifting the abdominal wall before Veress Needle insertion when compared to lifting in terms of failed entry, without an increase in the complication rate (Peto OR 4.44, 95% CI 2.16 to 9.13). However, studies were limited to small numbers, excluding many patients with previous abdominal surgery and women with a raised body mass index who may have unusually high complication rates. AUTHORS' CONCLUSIONS: An open-entry technique is associated with a significant reduction in failed entry when compared to a closed-entry technique, with no difference in the incidence of visceral or vascular injury.Significant benefits were noted with the use of a direct-entry technique when compared to the Veress Needle. The use of the Veress Needle was associated with an increased incidence of failed entry, extraperitoneal insufflation and omental injury; direct-trocar entry is therefore a safer closed-entry technique.The low rate of reported complications associated with laparoscopic entry and the small number of participants within the included studies may account for the lack of significant difference in terms of major vascular and visceral injury between entry techniques. Results should be interpreted with caution for outcomes where only single studies were included.

Pain relief in office gynaecology: a systematic review and meta-analysis.

Hysteroscopy, hysterosalpingography (HSG), sonohysterography and endometrial ablation are increasingly performed in an outpatient setting. The primary reason for failure to complete these procedures is pain. The objective of this review was to compare the effectiveness and safety of different types of pharmacological intervention for pain relief in office gynaecological procedures. A systematic search of medical databases including PubMed, EMBASE, Cochrane Central register of controlled trials, PsychInfo and CINHAL was conducted in 2009. Randomised controlled trials (RCTs) investigating the use of local anaesthetics, opioid analgesics, non-opioid analgesics and intravenous sedation for pain relief during and after hysteroscopy, HSG, sonohysterography and endometrial ablation were reviewed. Secondary outcomes included adverse effects and failure to complete procedures. Where RCTs were not identified, the best available evidence was sought. Each study was assessed against inclusion criterion. Results for each study were expressed as a standardised mean difference (SMD) with 95% confidence intervals and combined for meta-analysis with Revman 5 software. Meta-analysis revealed beneficial effect of the use of local anaesthetics during and within 30 min after hysteroscopy; SMD -0.45 (95% CI -0.73, -0.17) and SMD -0.51 (95% CI -0.81, -0.21) respectively. No beneficial effect was noted during HSG. One RCT found evidence of benefit for pain relief during hysterosalpingo-contrastsonography; SMD -1.04 [95% CI -1.44, -0.63]. There was no significant difference in failure to complete hysteroscopy due to cervical stenosis between the intervention and control groups (OR 1.31 (95% CI 0.66, 2.59)), but the incidence of failure to complete the procedure due to pain was significantly less in the intervention group (OR 0.29 (0.12, 0.69)). There is evidence of benefit for the use of local anaesthetics for outpatient hysteroscopy and hysterosalpingo-contrastsonography. Local anaesthetics may be considered when performing hysteroscopy in postmenopausal women to reduce the failure rate.

Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice.

BACKGROUND: Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned. There are no national guidelines on pain relief for outpatient hysteroscopy. METHODS: A postal survey of UK gynaecologists was carried out to evaluate current clinical practice regarding methods of pain relief used during office hysteroscopy. A total of 250 questionnaires were sent out and 115 responses received. RESULTS: Outpatient hysteroscopy was offered by 76.5% of respondents. Respondents reported a wide variation in the use of routine and rescue analgesia, and also in the nature of the analgesia used. One-quarter of those offering outpatient hysteroscopy used no form of analgesia. CONCLUSION: The results showed that whilst there is no consensus on the type of analgesia provided, rescue analgesia is commonly being used, particularly in the form of intracervical blocks.

Pain relief for outpatient hysteroscopy.

BACKGROUND: Hysteroscopy is increasingly performed in an outpatient setting. The primary reason for failure is pain. There is no consensus upon the routine use of analgesia during hysteroscopy. OBJECTIVES: The aim of the study was to compare the effectiveness of different types of pharmacological interventions for pain relief in patients undergoing hysteroscopy. SEARCH STRATEGY: A search of medical literature databases including PubMed, EMBASE, PsycINFO and CINHAL (to February 2010). SELECTION CRITERIA: Randomised controlled trials (RCTs) investigating pharmacological interventions for pain relief during hysteroscopy were investigated. DATA COLLECTION AND ANALYSIS: Results for each study were expressed as a standardised mean difference with 95% confidence interval and combined for meta-analysis with Revman 5 software. MAIN RESULTS: Twenty-four RCTS were identified involving a total of 3155 participants, with 15 studies included in the meta-analysis.Meta-analysis (nine RCTs, 1296 participants) revealed a significant reduction in the mean pain score for the use of local anaesthetics during the procedure compared with placebo (SMD -0.45, 95% CI -0.73 to -0.17, I(2) = 82%).Meta-analysis (4 RCTs, 454 participants) demonstrated a significant reduction in the mean pain score for the use of local anaesthetics within 30 minutes after the procedure compared with placebo (SMD -0.51, 95% CI -0.81 to -0.21, I(2) = 54%).There was no significant reduction in the mean pain score with the use of NSAIDS or opioid analgesics compared with placebo during or within 30 minutes after the procedure.There was no significant reduction in the mean pain score with the use of local anaesthetics, NSAIDS or opioid analgesics compared with placebo more than 30 minutes after the procedure.There was no significant difference between the number of incidents of failure to complete the procedure due to cervical stenosis between the intervention and control groups (OR 1.31, 95% CI 0.66 to 2.59; 6 RCTs, 805 participants).There were significantly fewer incidents of failure to complete the procedure due to pain in the intervention group than in the control group (OR 0.29, 95% CI 0.12 to 0.69; two studies, 330 participants).Meta-analysis demonstrated no significant difference between the intervention and placebo groups with regards to adverse effects. AUTHORS' CONCLUSIONS: There was a significant reduction in the mean pain score with the use of analgesia during and within 30 minutes after outpatient hysteroscopy.