Efficacy of Lidocaine Spray for Pain Reduction during Colposcopy-Directed Cervical Biopsies: A Randomized Controlled Trial.

Objectives: The objective of this study was to evaluate the efficacy of lidocaine spray in reducing the pain during colposcopy-directed cervical biopsy (CDB). Methods: From December 2017 to February 2019, 312 women undergoing CDBs were enrolled. The participants were randomized to three groups: group 1 (lidocaine spray), in which lidocaine spray was applied thoroughly to the cervix; group 2 (placebo), in which normal saline was applied thoroughly to the cervix; and group 3 (control), in which no anesthetic agent was applied to the cervix. Each woman completed a 10 cm visual analog scale to classify the subjective pain experience at three time points: baseline, immediately after biopsy, and 10 min after the procedure. The primary outcome of this study was the biopsy pain score. Results: The 312 enrolled women were randomly assigned to the three groups, amounting to 104 women per group. The clinical and pathological characteristics of the participants in all groups were comparable. The baseline, the biopsy, and the post-procedure pain scores were comparable among the three groups. There was a significant increase in the pain score from baseline to biopsy and from baseline to post-procedure in each group. The pain-score changes from baseline to biopsy in the lidocaine spray group significantly decreased when compared with the normal saline group (<0.001), and tended to decrease, though not significantly (p = 0.06), when compared with the control group. No complication with the intervention was observed. Conclusions: The application of lidocaine spray to the cervix has the benefit of reducing the pain associated with CDBs by a small amount. However, the intervention is safe and may be considered in nulliparous and/or overly anxious women undergoing the procedure.

Effect of cancer stage on health-related quality of life of patients with epithelial ovarian cancer.

We compared the quality of life (QoL) of women with early versus advanced epithelial ovarian cancer and examined predicting factors for the poor QoL. We classified 157 participants into 108 with early disease (stage I-II) and 49 with advanced disease (stage III-IV). They completed two questionnaires: EORTC QLQ-C30 and Chiang Mai University (CMU) ovarian cancer QoL. For EORTC QLQ-C30, the study groups were comparable regarding global health status/QoL, functional scales, and summary scores. The advanced group had worse scores on symptom scales specifically appetite loss and constipation. For CMU Ovarian Cancer QoL, the advanced group had worse scores only in the gastrointestinal domain but not in urinary, lymphatic, and sexual/hormonal domains. These findings remained mostly unchanged after excluding those with recurrence. In multivariable analysis, currently receiving treatment was consistently associated with worse QoL scores. The advanced stage had more adverse impact only on the gastrointestinal domains of QoL, mainly during periods of receiving chemotherapy.IMPACT STATEMENTWhat is already known on this subject? Survival outcome for women with epithelial ovarian cancer varies depending mainly on stage. Those who survive advanced stage disease could expect long-term disease and treatment-related morbidities that significantly affected QoL. However, there has been very limited information regarding QoL of women who have the early disease in comparison to those with more advanced disease especially in the context of Asian culture.What do the results of this study add? Apart from the higher prevalence of gastrointestinal symptoms reported by the patients with advanced disease, the general well-being and other symptom-specific domains of QoL were comparable between women with early and advanced diseases. Receiving treatment is a consistent predictor for poor QoL.What are the implications of these findings for clinical practice and/or further research? In comparison to early-stage epithelial ovarian cancer, the advanced stage had more adverse impact only on the gastrointestinal domains of QoL, mainly during periods of receiving chemotherapy. This information will be useful for patient counselling. Future research should examine the underlying causes of this finding.

Health-related quality of life for early-stage cervical cancer survivors after primary radical surgery followed by radiotherapy versus radical surgery alone.

This study compared the quality of life (QoL) of 265 stage IA2-IIA cervical cancer patients treated with radical surgery alone (group 1: 137 patients) versus those who underwent primary radical surgery followed by radiotherapy (group 2: 128 patients) and identified clinical characteristics that predict the poor quality of life. All participants completed quality of life questionnaires: EORTC QLQ-C30 and CMU cervical cancer QoL. For the EORTC QLQ-C30, the study groups were comparable regarding global health status/QoL scale and summary scores. Group 1 participants had better scores on the physical functioning domain and some symptom scales/items. For the CMU Cervical Cancer QoL, group 1 participants had better scores on gastrointestinal, lymphatic, and sexual/hormonal domains. In multivariable analysis, adjuvant radiation was consistently associated with poor quality of life in most domains. In general, early-stage cervical cancer survivors had a satisfactory quality of life. The clinical significance of the quality of life score differences between the study groups remains debateable.Impact statementWhat is already known on this subject? For women with early cervical cancer, surgery is the main treatment providing not only a good chance for a cure by total removal of the cancer but also an opportunity to preserve the hormone-producing function of the ovary as well as the flexibility of the vagina. However, radiation treatment may be indicated after surgery in some patients depending on the findings from surgery. Because of the concern about increased complications and decreased long-term quality of life following the combined treatments, some may elect to avoid surgery and receive radiation alone in the first place. In this study, we compared the quality of life of women who had surgery alone to those who had surgery followed by radiation. This information is currently lacking in the medical literature.What do the results of this study add? We found that, in general, women with early cervical cancer had a satisfactory quality of life. For a patient who is surgically fit and chooses to receive primary surgery, if radiation is subsequently required, she could still expect the acceptable long-term quality of life-although slightly less satisfactory than receiving surgery alone but not inferior to those who receive primary radiation treatment.What are the implications of these findings for clinical practice and/or further research? These findings will be useful for pre-treatment counselling and posttreatment supportive care. The information regarding disease-related and treatment-induced morbidity should be thoroughly discussed with the patients before and after treatment. Also, the use of questionnaires examining general well-being together with a cancer-specific quality of life is recommended for the systematic evaluation of cancer survivors.

Efficacy of Listening to Music on Pain Reduction during Colposcopy-Directed Cervical Biopsy: A Randomized, Controlled Trial.

Background and Objective: To investigate the efficacy of listening to music on pain reduction during colposcopy-directed cervical biopsy (CDB). Materials and Methods: From June 2020 to November 2021, 240 women undergoing CDB were enrolled. The participants were randomized into three groups: Group 1, colposcopic examination while wearing headphones and listening to music; Group 2, colposcopy while wearing headphones but not listening to music; Group 3 (control group), colposcopy while neither listening to music nor wearing headphones. All participating women completed a 10 cm visual analog scale for subjective pain at three time points: baseline, immediately after cervical biopsy, and 15 min after the procedure. The primary endpoint was the biopsy pain score. Result: Of the 240 women, a sample size of 80 was randomly assigned per group. The clinical-pathological and procedure-related characteristics of the participants in all groups were similar. The mean baseline pain score between each group was not significantly different (2.83 in the music group, 2.54 in group 2, and 2.94 in the control group, p = 0.47). There were no significant differences between each group in terms of mean biopsy pain score (4.21 in the music group, 4.24 in group 2, and 4.30 in the control group, p = 0.98). The differences in changes between the baseline pain score and the biopsy pain score were not statistically significant (1.39 in the music group, 1.70 in group 2, and 1.36 in the control group, p = 0.69). In the multiple comparison analysis, the differences in changes between the biopsy pain score and the baseline pain score between each group were also not statistically significant. There were no complications with the intervention observed. Conclusion: This study demonstrated that there was no beneficial effect of listening to music on pain reduction during colposcopy-directed cervical biopsies.

Effect of Elastic Abdominal Binder on Pain and Functional Recovery Following Gynecologic Cancer Surgery: A Randomized Controlled Trial.

Background and Objectives: Clinicians have been using elastic abdominal binder for stabilizing incision site after major abdominal surgery. However, the benefits of that practice have never been formally assessed. The aim of this study was to examine the effects of the use of elastic abdominal binder on postoperative pain and recovery of gynecologic cancer patients. Materials and Methods: One-hundred and nine women diagnosed with cervical, endometrial, or ovarian cancer, who underwent open abdominal surgery were assigned randomly into two groups: intervention (56 patients) and control (53 patients). The women in the intervention group applied abdominal binder from postoperative day 1. For the control group, the women did not wear the binder or similar devices. The primary outcomes were pain and functional recovery. Subgroup analysis on participants age ≥ 50 was also performed. Results: For the entire study cohort, the baseline, postoperative day 1, and postoperative day 2 pain scores in the intervention group were significantly lower than the control group. However, there was no significant difference between the groups for postoperative day 3 pain score and for the change in pain scores from the baseline value. Of note, the age ≥ 50 subgroup represented a more balanced cohort with comparable baseline pain scores between the study groups. For this population, the pain scores for postoperative day 1-3 were significantly lower in the intervention group. The intervention group had a longer six-minute walking distance on postoperative day 3 with a trend toward a smaller difference in the day 3 distance from the baseline. Conclusions: The potential benefits of abdominal binder use in reducing postoperative pain and improving functional recovery after open gynecologic cancer surgery could be demonstrated only in those age ≥ 50.

Health education interventions to promote early presentation and referral for women with symptoms of endometrial cancer.

BACKGROUND: Diagnosis of endometrial (womb) cancer is normally made at an early stage, as most women with the disease experience abnormal vaginal bleeding, which prompts them to seek medical advice. However, delays in presentation and referral can result in delay in diagnosis and management, which can lead to unfavourable treatment outcomes. This is particularly a problem for pre- and peri-menopausal women. Providing educational information to women and healthcare providers regarding symptoms relating to endometrial cancer may raise awareness of the disease and reduce delayed treatment. OBJECTIVES: To assess the effectiveness of health education interventions targeting healthcare providers, or individuals, or both, to promote early presentation and referral for women with endometrial cancer symptoms. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs), both individually randomised and cluster-RCTs. In the absence of RCTs we planned to include well-designed non-randomised studies (NRS) with a parallel comparison assessing the benefits of any type of health education interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated whether potentially relevant studies met the inclusion criteria for the review, but none were found. MAIN RESULTS: A comprehensive search of the literature yielded the following results: CENTRAL (1022 references), MEDLINE (2874 references), and Embase (2820 references). After de-duplication, we screened titles and abstracts of 4880 references and excluded 4864 that did not meet the review inclusion criteria. Of the 16 references that potentially met the review inclusion, we excluded all 16 reports after reviewing the full texts. We did not identify any ongoing trials. AUTHORS' CONCLUSIONS: There is currently an absence of evidence to indicate the effectiveness of health education interventions involving healthcare providers or individuals or both to promote early presentation and referral for women with endometrial cancer symptoms. High-quality RCTs are needed to assess whether health education interventions enhance early presentation and referral. If health education interventions can be shown to reduce treatment delays in endometrial cancer, further studies would be required to determine which interventions are most effective.

Methods of pain control during endometrial biopsy: A systematic review and meta-analysis of randomized controlled trials.

AIM: To review effectiveness of methods for reducing pain during endometrial biopsy. METHODS: PubMed, Scopus, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov databases were searched for randomized controlled trials that examined effectiveness of pain control methods for endometrial biopsy. Risk of bias was assessed from sequence generation, allocation concealment, blinding, incomplete outcome data and selective outcome reporting. Heterogeneity was examined from forest plot, statistical tests of homogeneity, and I2 statistic. For meta-analysis of pain scores, weighted mean difference with 95% confidence interval (CI) were estimated. RESULTS: Twenty-six studies were included in the review. Marginally significant reduction in the pain score during the procedure in participants with intrauterine lidocaine relative to control was observed (mean difference [MD] -1.31, 95% confidence interval [CI] -2.70 to 0.09, P = 0.07). Subgroup analysis showed that in studies that used low-pressure suction devices, intrauterine lidocaine was associated with statistically significant reduction in pain during the procedure (MD -2.22, 95% CI -3.72 to -0.73, P = 0.004). There was a significantly lower pain score during biopsy in the anesthetic spray group compared to control (MD -0.96, 95% CI -1.53 to -0.39, P = 0.001). Significant heterogeneity on types of intervention and outcome measures among studies that examined paracervical block and nonsteroidal anti-inflammatory drugs (NSAID) was observed. However, paracervical block and NSAID were associated with significant pain reduction compared to placebo in most of the related studies. CONCLUSION: Intrauterine anesthetics, anesthetic cervical spray, paracervical block and oral NSAID provide effective pain control during endometrial biopsy.

Effect of elastic abdominal binder on pain and functional recovery after caesarean delivery: a randomised controlled trial.

The Elastic abdominal binder has been widely employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilisation. However, these proposed benefits have not been properly examined in women following caesarean delivery. We aimed to examine the effects of post-caesarean elastic abdominal binder use on recovery by comparing post-operative pain, mobility and quality of life. Pregnant women undergoing caesarean delivery were randomly assigned into two groups: abdominal binder (90 patients) and control (90 patients). The primary outcomes included the daily visual analogue scale pain scores and the distance from the six-minute walk test. Baseline characteristics were similar between the groups. There was no significant difference in pain scores and six-minute walking distance between the study groups. There was no significant between-group difference in quality-of-life dimensions, overall health status, and post-operative complication. The positive effects of elastic abdominal binder use following caesarean delivery could not be demonstrated in this study.Impact statementWhat is already known on this subject? Elastic abdominal binder is commonly used after laparotomy to support incision. There was evidence to support the benefit of abdominal binder in reducing psychological distress during the first five days following laparotomy for other indications. From limited number of studies addressing caesarean section, the evidence for the benefits of the binder on pain, symptom distress, and change in haemoglobin level is conflicting.What do the results of this study add? In contrast to the results of the previous study, the beneficial effects of abdominal binder on pain reduction, functional recovery, and quality of life following caesarean delivery could not be demonstrated in this study.What are the implications of these findings for clinical practice and/or further research? The use of elastic abdominal binder after caesarean delivery is not associated with reduction of postoperative pain, faster functional recovery, and improved quality of life in our population. Further studies in other population with different characteristics may be worthwhile.

Effects of lidocaine spray for reducing pain during endometrial aspiration biopsy: A randomized controlled trial.

AIM: To examine the effect of lidocaine spray for reducing pain during endometrial aspiration biopsy by comparing it with placebo and no intervention. METHODS: Women undergoing endometrial aspiration biopsy from March 2017 to January 2018 were invited to participate. The participants were randomly assigned into three groups. In group 1 (lidocaine spray), eight puffs (80 mg, 10 mg/puff, 0.8 mL) of 10% lidocaine spray was applied thoroughly to the cervix, 3 min before starting the procedure. For group 2 (placebo spray), 0.8 mL of normal saline spray was applied to the cervix, 3 min before starting the procedure. For group 3 (no intervention), no anesthesia was given. The patients rated their pain according to a 10-cm visual analog scale at different points including baseline, immediately after the procedure (biopsy pain), and 10 min after the procedure. The 10-cm visual analog scale on satisfaction was also rated before hospital discharge. Comparison of continuous variables was made by using Kruskal-Wallis test. Chi squared test was used for comparison of categorical variables. RESULTS: Two hundred and forty patients (80 in each group) participated. The mean baseline, biopsy and postprocedural pain scores were not significantly different among the study groups. Similarly, the mean difference between the biopsy and the baseline pain scores were comparable among the groups. In addition, there was no difference on the satisfaction scores among the groups. CONCLUSION: Lidocaine spray applied to the cervix is not effective for reducing pain associated with pipelle endometrial aspiration biopsy.

Retroperitoneal drainage versus no drainage after pelvic lymphadenectomy for the prevention of lymphocyst formation in women with gynaecological malignancies.

BACKGROUND: This is an updated version of an original Cochrane review published in Issue 6, 2014. Pelvic lymphadenectomy is associated with significant complications including lymphocyst formation and related morbidities. Retroperitoneal drainage using suction drains has been recommended as a method to prevent such complications. However, findings from recent studies have challenged this policy. OBJECTIVES: To assess the effects of retroperitoneal drainage versus no drainage after pelvic lymphadenectomy on lymphocyst formation and related morbidities in women with gynaecological cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 3, 2017) in the Cochrane Library, electronic databases MEDLINE (1946 to March Week 2, 2017), Embase (1980 to 2017 week 12), and the citation lists of relevant publications. We also searched the trial registries for ongoing trials on 20 May 2017. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared the effect of retroperitoneal drainage versus no drainage after pelvic lymphadenectomy in women with gynaecological cancer. Retroperitoneal drainage was defined as placement of passive or active suction drains in pelvic retroperitoneal spaces. No drainage was defined as no placement of passive or active suction drains in pelvic retroperitoneal spaces. DATA COLLECTION AND ANALYSIS: We assessed studies using methodological quality criteria. For dichotomous data, we calculated risk ratios (RRs) and 95% confidence intervals (CIs). We examined continuous data using mean difference (MD) and 95% CI. MAIN RESULTS: Since the last version of this review, we have identified no new studies for inclusion. The review included four studies with 571 women. Regarding short-term outcomes (within four weeks after surgery), retroperitoneal drainage was associated with a comparable rate of overall lymphocyst formation when all methods of pelvic peritoneum management were considered together (2 studies; 204 women; RR 0.76, 95% CI 0.04 to 13.35; moderate-quality evidence). When the pelvic peritoneum was left open, the rates of overall lymphocyst formation (1 study; 110 women; RR 2.29, 95% CI 1.38 to 3.79) and symptomatic lymphocyst formation (2 studies; 237 women; RR 3.25, 95% CI 1.26 to 8.37) were higher in the drained group. At 12 months after surgery, the rates of overall lymphocyst formation were comparable between the groups (1 study; 232 women; RR 1.48, 95% CI 0.89 to 2.45; high-quality evidence). However, there was a trend toward increased risk of symptomatic lymphocyst formation in the group with drains (1 study; 232 women; RR 7.12, 95% CI 0.89 to 56.97; low-quality evidence). AUTHORS' CONCLUSIONS: Placement of retroperitoneal tube drains has no benefit in the prevention of lymphocyst formation after pelvic lymphadenectomy in women with gynaecological malignancies. When the pelvic peritoneum is left open, the tube drain placement is associated with a higher risk of short- and long-term symptomatic lymphocyst formation. We found the quality of evidence using the GRADE approach to be moderate to high for most outcomes, except for symptomatic lymphocyst formation at 12 months after surgery, and unclear or low risk of bias.

Scalpel versus electrosurgery for major abdominal incisions.

BACKGROUND: Scalpels or electrosurgery can be used to make abdominal incisions. The potential benefits of electrosurgery may include reduced blood loss, dry and rapid separation of tissue, and reduced risk of cutting injury to surgeons. Postsurgery risks possibly associated with electrosurgery may include poor wound healing and complications such as surgical site infection. OBJECTIVES: To assess the effects of electrosurgery compared with scalpel for major abdominal incisions. SEARCH METHODS: The first version of this review included studies published up to February 2012. In October 2016, for this first update, we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, EBSCO CINAHL Plus, and the registry for ongoing trials (www.clinicaltrials.gov). We did not apply date or language restrictions. SELECTION CRITERIA: Studies considered in this analysis were randomised controlled trials (RCTs) that compared electrosurgery to scalpel for creating abdominal incisions during major open abdominal surgery. Incisions could be any orientation (vertical, oblique, or transverse) and surgical setting (elective or emergency). Electrosurgical incisions were made through major layers of the abdominal wall, including subcutaneous tissue and the musculoaponeurosis (a sheet of connective tissue that attaches muscles), regardless of the technique used to incise the skin and peritoneum. Scalpel incisions were made through major layers of abdominal wall including skin, subcutaneous tissue, and musculoaponeurosis, regardless of the technique used to incise the abdominal peritoneum. Primary outcomes analysed were wound infection, time to wound healing, and wound dehiscence. Secondary outcomes were postoperative pain, wound incision time, wound-related blood loss, and adhesion or scar formation. DATA COLLECTION AND ANALYSIS: Two review authors independently carried out study selection, data extraction, and risk of bias assessment. When necessary, we contacted trial authors for missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) for dichotomous data, and mean differences (MD) and 95% CI for continuous data. MAIN RESULTS: The updated search found seven additional RCTs making a total of 16 included studies (2769 participants). All studies compared electrosurgery to scalpel and were considered in one comparison. Eleven studies, analysing 2178 participants, reported on wound infection. There was no clear difference in wound infections between electrosurgery and scalpel (7.7% for electrosurgery versus 7.4% for scalpel; RR 1.07, 95% CI 0.74 to 1.54; low-certainty evidence downgraded for risk of bias and serious imprecision). None of the included studies reported time to wound healing.It is uncertain whether electrosurgery decreases wound dehiscence compared to scalpel (2.7% for electrosurgery versus 2.4% for scalpel; RR 1.21, 95% CI 0.58 to 2.50; 1064 participants; 6 studies; very low-certainty evidence downgraded for risk of bias and very serious imprecision).There was no clinically important difference in incision time between electrosurgery and scalpel (MD -45.74 seconds, 95% CI -88.41 to -3.07; 325 participants; 4 studies; moderate-certainty evidence downgraded for serious imprecision). There was no clear difference in incision time per wound area between electrosurgery and scalpel (MD -0.58 seconds/cm2, 95% CI -1.26 to 0.09; 282 participants; 3 studies; low-certainty evidence downgraded for very serious imprecision).There was no clinically important difference in mean blood loss between electrosurgery and scalpel (MD -20.10 mL, 95% CI -28.16 to -12.05; 241 participants; 3 studies; moderate-certainty evidence downgraded for serious imprecision). Two studies reported on mean wound-related blood loss per wound area; however, we were unable to pool the studies due to considerable heterogeneity. It was uncertain whether electrosurgery decreased wound-related blood loss per wound area. We could not reach a conclusion on the effects of the two interventions on pain and appearance of scars for various reasons such as small number of studies, insufficient data, the presence of conflicting data, and different measurement methods. AUTHORS' CONCLUSIONS: The certainty of evidence was moderate to very low due to risk of bias and imprecise results. Low-certainty evidence shows no clear difference in wound infection between the scalpel and electrosurgery. There is a need for more research to determine the relative effectiveness of scalpel compared with electrosurgery for major abdominal incisions.

Effect of lidocaine spray during colposcopy-directed cervical biopsy: A randomized controlled trial.

AIM: We aimed to examine the effect of lidocaine spray in reducing pain during colposcopy-directed cervical biopsy (CDB). METHODS: Two hundred women with abnormal cervical screening test results and abnormal colposcopic findings that required a CDB during April to December 2015 were enrolled. The participants were randomly assigned into one of two groups. For group 1 (lidocaine group), 10% lidocaine spray was applied thoroughly to the ectocervix. For group 2, no anesthesia was given. The primary outcome of this study was the biopsy pain score. RESULTS: Of the 200 women enrolled, 100 were randomly assigned to group 1 and 100 were in group 2. The baseline, biopsy, and postprocedure pain scores were comparable between the study groups. The mean difference between the biopsy and the baseline pain scores and the mean difference of the postprocedure pain scores from baseline were statistically significantly higher in the no-anesthesia group (group 2), P = 0.01 and P = 0.02, respectively. However, the degree of pain was minimal in both groups. There were no complications observed in any participants. CONCLUSION: Lidocaine spray reduces pain during colposcopy-directed cervical biopsy; however, the clinically meaningful effect of such a procedure cannot be demonstrated in this study.

Effects of Music Listening During Loop Electrosurgical Excision Procedure on Pain and Anxiety: A Randomized Trial.

OBJECTIVE: The aim of the study was to compare pain, anxiety, and satisfaction between women, who listened to music, and those who did not during loop electrosurgical excision procedure (LEEP). MATERIAL AND METHODS: Participants were randomly assigned into two groups. In group 1 (music), the participants listened to relaxing instrumental music through the stereo headset from the time of arrival at the preoperative waiting room until the procedure completed. For group 2 (control), the participants underwent LEEP without music listening. The women rated pain, anxiety, and satisfaction according to 10-cm visual analog scales. Pain was assessed at the time of speculum insertion (baseline pain) and immediately after the LEEP completed (procedural pain). Anxiety and satisfaction were examined just before starting the LEEP and 10 minutes after the procedure completed. RESULTS: One hundred fifty patients (74 in music group and 76 in control group) participated. Mean baseline pain scores after speculum insertion were comparable between the groups (3.7 in the music group vs. 3.5 in the control group, p = .55). Mean procedural pain scores were not different between the groups (4.7 in the music group vs. 5.2 in the control group, p = .32). The differences of the procedural pain scores from baseline were statistically comparable between the study groups (0.9 in the music group vs. 1.7 in the control group, p = .15). There were no significant differences in anxiety and satisfaction scores at any time points assessed between the groups. CONCLUSIONS: The effects of music listening on reducing pain and anxiety during LEEP could not be demonstrated in this study.

Effective use of the Bakri postpartum balloon for posthysterectomy pelvic floor hemorrhage.

After hysterectomy, massive pelvic floor hemorrhage sometimes occurs, especially in those who underwent complicated procedures. Conventional methods frequently fail to control this type of life-threatening bleeding. This report demonstrates the successful application of the large-volume Bakri balloon as a pelvic pressure pack for the control of intractable pelvic floor hemorrhage after hysterectomy in 3 consecutive cases. The Bakri balloon was introduced through the laparotomy incision and was passed inflation port first through a small posterior culdotomy to the vagina. The shaft of the balloon then was pulled through the vaginal canal. When proper tamponade position was achieved, the balloon was inflated gradually with sterile normal saline solution up to the minimal volume that effectively compressed against the pelvic floor and successfully controlled the hemorrhage. Continuous traction was used by the connection of the balloon shaft to a 1-L intravenous fluid bag that was hanging from the end of the bed. In all cases, the bleeding was controlled promptly when the balloons were filled up to 400-550 mL. The balloons were removed at bedside 24-30 hours after the operation. On follow-up examination, all patients recovered well without complication. From the author's experience, pelvic pressure packing with the Bakri balloon can be an immediate lifesaver. It is safe and readily applicable and provides a period of temporary hemostasis during which time volume replacement and coagulation defect correction can be obtained. The balloon pack can be removed vaginally without the need for reexploration. It is easy and fast to assemble, apply, and remove. In addition, the size of the balloon pack is adjustable easily to match the size of hemorrhagic areas by merely inflating or deflating the balloon. Furthermore, it is convenient to monitor continuing intraabdominal blood loss through the balloon's drainage port without the need for an additional drain. Further exploration on its use would be worthwhile.

Retroperitoneal drainage versus no drainage after pelvic lymphadenectomy for the prevention of lymphocyst formation in patients with gynaecological malignancies.

BACKGROUND: This is an updated version of the original Cochrane review published in Issue 1, 2010. Pelvic lymphadenectomy is associated with significant complications including lymphocyst formation and related morbidities. Retroperitoneal drainage using suction drains has been recommended as a method to prevent such complications. However, this policy has been challenged by the findings from recent studies. OBJECTIVES: To assess the effects of retroperitoneal drainage versus no drainage after pelvic lymphadenectomy on lymphocyst formation and related morbidities in gynaecological cancer patients. SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 12) in The Cochrane Library, electronic databases MEDLINE (Nov Week 3, 2013), EMBASE (2014, week 1), and the citation lists of relevant publications. The latest searches were performed on 10 January 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared the effect of retroperitoneal drainage versus no drainage after pelvic lymphadenectomy in gynaecological cancer patients. Retroperitoneal drainage was defined as placement of passive or active suction drains in pelvic retroperitoneal spaces. No drainage was defined as no placement of passive or active suction drains in pelvic retroperitoneal spaces. DATA COLLECTION AND ANALYSIS: We assessed studies using methodological quality criteria. For dichotomous data, we calculated risk ratios (RRs) and 95% confidence intervals (CIs). We examined continuous data using mean difference (MD) and 95% CI. MAIN RESULTS: Since the last version of this review, no new studies have been identified for inclusion. The review included four studies with 571 participants. Considering the short-term outcomes (within four weeks after surgery), retroperitoneal drainage was associated with a comparable rate of overall lymphocyst formation when all methods of pelvic peritoneum management were considered together (two studies, 204 patients; RR 0.76, 95% CI 0.04 to 13.35). When the pelvic peritoneum was left open, the rates of overall lymphocyst formation (one study, 110 patients; RR 2.29, 95% CI 1.38 to 3.79) and symptomatic lymphocyst formation (one study, 137 patients; RR 3.25, 95% CI 1.26 to 8.37) were higher in the drained group. At 12 months after surgery, the rates of overall lymphocyst formation were comparable between the groups (one study, 232 patients; RR 1.48, 95% CI 0.89 to 2.45). However, there was a trend toward increased risk of symptomatic lymphocyst formation in the group with drains (one study, 232 patients; RR 7.12, 95% CI 0.89 to 56.97). The included trials were of low to moderate risk of bias. AUTHORS' CONCLUSIONS: Placement of retroperitoneal tube drains has no benefit in prevention of lymphocyst formation after pelvic lymphadenectomy in patients with gynaecological malignancies. When the pelvic peritoneum is left open, the tube drain placement is associated with a higher risk of short and long-term symptomatic lymphocyst formation.

Early versus delayed oral fluids and food for reducing complications after major abdominal gynaecologic surgery.

BACKGROUND: This is an updated version of the original Cochrane review published in 2007. Traditionally, after major abdominal gynaecologic surgery postoperative oral intake is withheld until the return of bowel function. There has been concern that early oral intake would result in vomiting and severe paralytic ileus with subsequent aspiration pneumonia, wound dehiscence, and anastomotic leakage. However, evidence-based clinical studies suggest that there may be benefits from early postoperative oral intake. OBJECTIVES: To assess the effects of early versus delayed (traditional) initiation of oral intake of food and fluids after major abdominal gynaecologic surgery. SEARCH METHODS: We searched the Menstrual Disorders and Subfertility Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), electronic databases (MEDLINE, EMBASE, CINAHL), and the citation lists of relevant publications. The most recent search was conducted 1 April 2014. We also searched a registry for ongoing trials (www.clinicaltrials.gov) on 13 May 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) were eligible that compared the effect of early versus delayed initiation of oral intake of food and fluids after major abdominal gynaecologic surgery. Early feeding was defined as oral intake of fluids or food within 24 hours post-surgery regardless of the return of bowel function. Delayed feeding was defined as oral intake after 24 hours post-surgery and only after signs of postoperative ileus resolution. DATA COLLECTION AND ANALYSIS: Two review authors selected studies, assessed study quality and extracted the data. For dichotomous data, we calculated the risk ratio (RR) with a 95% confidence interval (CI). We examined continuous data using the mean difference (MD) and a 95% CI. We tested for heterogeneity between the results of different studies using a forest plot of the meta-analysis, the statistical tests of homogeneity of 2 x 2 tables and the I² value. We assessed the quality of the evidence using GRADE methods. MAIN RESULTS: Rates of developing postoperative ileus were comparable between study groups (RR 0.47, 95% CI 0.17 to 1.29, P = 0.14, 3 RCTs, 279 women, I² = 0%, moderate-quality evidence). When we considered the rates of nausea or vomiting or both, there was no evidence of a difference between the study groups (RR 1.03, 95% CI 0.64 to 1.67, P = 0.90, 4 RCTs, 484 women, I² = 73%, moderate-quality evidence). There was no evidence of a difference between the study groups in abdominal distension (RR 1.07, 95% CI 0.77 to 1.47, 2 RCTs, 301 women, I² = 0%) or a need for postoperative nasogastric tube placement (RR 0.48, 95% CI 0.13 to 1.80, 1 RCT, 195 women).Early feeding was associated with shorter time to the presence of bowel sound (MD -0.32 days, 95% CI -0.61 to -0.03, P = 0.03, 2 RCTs, 338 women, I² = 52%, moderate-quality evidence) and faster onset of flatus (MD -0.21 days, 95% CI -0.40 to -0.01, P = 0.04, 3 RCTs, 444 women, I² = 23%, moderate-quality evidence). In addition, women in the early feeding group resumed a solid diet sooner (MD -1.47 days, 95% CI -2.26 to -0.68, P = 0.0003, 2 RCTs, 301 women, I² = 92%, moderate-quality evidence). There was no evidence of a difference in time to the first passage of stool between the two study groups (MD -0.25 days, 95% CI -0.58 to 0.09, P = 0.15, 2 RCTs, 249 women, I² = 0%, moderate-quality evidence). Hospital stay was shorter in the early feeding group (MD -0.92 days, 95% CI -1.53 to -0.31, P = 0.003, 4 RCTs, 484 women, I² = 68%, moderate-quality evidence). Infectious complications were less common in the early feeding group (RR 0.20, 95% CI 0.05 to 0.73, P = 0.02, 2 RCTs, 183 women, I² = 0%, high-quality evidence). In one study, the satisfaction score was significantly higher in the early feeding group (MD 11.10, 95% CI 6.68 to 15.52, P < 0.00001, 143 women, moderate-quality evidence). AUTHORS' CONCLUSIONS: Early postoperative feeding after major abdominal gynaecologic surgery for either benign or malignant conditions appeared to be safe without increased gastrointestinal morbidities or other postoperative complications. The benefits of this approach include faster recovery of bowel function, lower rates of infectious complications, shorter hospital stay, and higher satisfaction.

Effects of Postoperative Gum Chewing on Recovery of Gastrointestinal Function Following Laparoscopic Gynecologic Surgery: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background: Chewing gum, considered a form of sham feeding, has been shown to improve intestinal motor and secretory function in various types of abdominal surgery. We conducted this systematic review to evaluate the effects of postoperative gum chewing on the recovery of gastrointestinal function after laparoscopic gynecologic surgery. Methods: We performed a comprehensive literature review of all randomized controlled trials (RCTs) in PubMed, Embase, and a reference list of relevant studies from the inception to 11 March 2024, comparing postoperative gum chewing versus no gum chewing following laparoscopic gynecologic surgery regardless of indications and setting without language restriction. The primary outcome was the time to the presence of bowel sounds and the time to the first passage of flatus. Cochrane's risk of bias tool was used to assess the risk of bias in included studies. Results: Nine RCTs with a total of 1011 patients were included. Overall, three studies were categorized as having a low risk of bias, three had some concerns, and three exhibited a high risk of bias. The time to the presence of bowel sounds (mean difference [MD] -2.66 h, 95% confidence interval [CI] -3.68 to -1.64, p < 0.00001) and time to the first passage of flatus (MD -4.20 h, 95% CI -5.79 to -2.61, p < 0.00001) was significantly shorter in the gum-chewing group. There was no statistical difference between the two groups with regard to the time to the first defecation (MD -6.52 h, 95% CI -15.70 to 2.66, p = 0.16), time to the first postoperative mobilization (MD 24.05 min, 95% CI -38.16 to 86.26, p = 0.45), postoperative ileus (MD 0.68, 95% CI 0.39 to 1.19, p = 0.17), and length of hospital stay (MD -0.05 day, 95% CI -0.14 to 0.04, p = 0.28). Conclusions: Gum chewing following laparoscopic gynecologic surgery appears to promote the recovery of gastrointestinal function, as evidenced by a reduced time to the presence of bowel sounds and the first passage of flatus.

A machine learning-based prediction model of pelvic lymph node metastasis in women with early-stage cervical cancer.

OBJECTIVE: To develop a novel machine learning-based preoperative prediction model for pelvic lymph node metastasis (PLNM) in early-stage cervical cancer by combining the clinical findings and preoperative computerized tomography (CT) of the whole abdomen and pelvis. METHODS: Patients diagnosed with International Federation of Gynecology and Obstetrics stage IA2-IIA1 squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma of the cervix who had primary radical surgery with bilateral pelvic lymphadenectomy from January 1, 2003 to December 31, 2020, were included. Seven supervised machine learning algorithms, including logistic regression, random forest, support vector machine, adaptive boosting, gradient boosting, extreme gradient boosting, and category boosting, were used to evaluate the risk of PLNM. RESULTS: PLNM was found in 199 (23.9%) of 832 patients included. Younger age, larger tumor size, higher stage, no prior conization, tumor appearance, adenosquamous histology, and vaginal metastasis as well as the CT findings of larger tumor size, parametrial metastasis, pelvic lymph node enlargement, and vaginal metastasis, were significantly associated with PLNM. The models' predictive performance, including accuracy (89.1%-90.6%), area under the receiver operating characteristics curve (86.9%-91.0%), sensitivity (77.4%-82.4%), specificity (92.1%-94.3%), positive predictive value (77.0%-81.7%), and negative predictive value (93.0%-94.4%), appeared satisfactory and comparable among all the algorithms. After optimizing the model's decision threshold to enhance the sensitivity to at least 95%, the 'highly sensitive' model was obtained with a 2.5%-4.4% false-negative rate of PLNM prediction. CONCLUSION: We developed prediction models for PLNM in early-stage cervical cancer with promising prediction performance in our setting. Further external validation in other populations is needed with potential clinical applications.

Alterations in mitochondria isolated from peripheral blood mononuclear cells and tumors of patients with epithelial ovarian cancers.

Metabolic alterations play an essential role in ovarian carcinogenesis. The flexibility of mitochondrial functions facilitates cellular adaptation to the tough environment associated with carcinogenesis. An understanding of the differences in mitochondrial functions in normal ovaries and cancers could provide a basis for further exploration of future mitochondria-based screening, diagnosis, prognostic prediction, and targeted therapy for epithelial ovarian cancers. The main objective of this study was to assess mitochondrial function profiles measured from PBMCs and ovarian tissues of epithelial ovarian cancers in comparison with normal ovaries. A total of 36 patients were recruited for the study, all of whom underwent primary surgical treatment for malignant epithelial ovarian neoplasm. Of these, 20 patients were in the early stage and 16 patients were in the advanced stage. Additionally, 21 patients who had pelvic surgery for benign gynecologic conditions, with normal ovaries incidentally removed, were recruited as controls. At the time of surgery, a blood sample was collected from each participant for PBMC isolation, and ovarian tissue was retained for molecular studies. These studies included the examination of oxidative stress, mitochondrial mass, mitochondrial respiration, mitochondrial reactive oxygen species (ROS), mitochondrial membrane potential (MMP) changes, and mitochondrial swelling. Clinical and histopathological data were also collected and compared between different stages of epithelial ovarian cancers: early-stage (group 1), advanced-stage (group 2), and normal ovaries (group 3). The levels of cellular oxidative stress, mitochondrial mass, and mitochondrial biogenesis in the peripheral blood mononuclear cells (PBMCs) of participants with ovarian cancer were significantly lower than those of the control group. However, the mitochondrial respiratory parameters measured from the PBMCs were similar across all three groups. Furthermore, mitochondrial membrane depolarization and mitochondrial swelling were observed in ovarian tissues of both early-stage and advanced-stage cancer groups. We demonstrated the dynamic nature of mitochondrial ROS production, biogenesis, and respiratory function in response to epithelial ovarian carcinogenesis. The flexibility of mitochondrial functions under diverse conditions may make it a challenging therapeutic target for ovarian cancer.

Use of the Bakri postpartum balloon in a patient with intractable pelvic floor hemorrhage: when other methods failed to stop postcesarean bleeding, physicians tried something new.

Massive pelvic floor hemorrhage is a potentially life-threatening condition associated with complicated obstetrical and gynecological procedures. Sometimes, the bleeding cannot be controlled by conventional methods. This report demonstrates the effectiveness of the Bakri balloon as a pelvic pressure pack for the control of intractable pelvic floor hemorrhage following cesarean section.