Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma.

BACKGROUND: Cholangiocarcinoma (cancer in the bile duct) is an aggressive tumour for which surgical resection is a mainstay of treatment. Despite complete resection, recurrences of the cancer are common and lead to poor prognosis in patients. Postoperative adjuvant chemotherapy given after surgical resection may reduce the risk of cancer recurrence by eradicating residual cancer and micrometastatic lesions. The benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies are unclear. OBJECTIVES: To assess the benefits and harms of postoperative adjuvant chemotherapy versus placebo, no intervention, or other adjuvant chemotherapies for people with cholangiocarcinoma after curative-intent resection. SEARCH METHODS: We performed electronic searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index - Science for trials that met the inclusion criteria up to 28 April 2021. SELECTION CRITERIA: Randomised clinical trials irrespective of blinding, publication status, or language comparing postoperative adjuvant chemotherapy versus placebo, no intervention, or a different postoperative adjuvant chemotherapy regimen for participants with curative-intent resection for cholangiocarcinoma. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods to develop and conduct the review. We conducted meta-analyses and presented results, where feasible, using a random-effects model and risk ratios (RR) with 95% confidence intervals (CI). We assessed risk of bias according to predefined domains suggested by Cochrane. We rated the certainty of evidence using the GRADE approach and presented outcome results in a summary of findings table. MAIN RESULTS: We included five published randomised clinical trials. The trials included 931 adults (18 to 83 years old) who underwent curative-intent resection for cholangiocarcinoma. Four trials compared postoperative adjuvant chemotherapy (mitomycin-C and 5-fluorouracil (5-FU); gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy (surgery alone) in 867 participants with cholangiocarcinoma only. A fifth trial compared postoperative adjuvant S-1 (a novel oral fluoropyrimidine derivative) chemotherapy versus gemcitabine in 70 participants with intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma (64 participants), and gallbladder carcinoma (6 participants). We assessed all of the included trials at overall high risk of bias. One trial was conducted in France, three in Japan, and one in the United Kingdom. We could not perform all planned comparison analyses due to lack of data. Three trials used intention-to-treat analyses. Another trial used per-protocol analysis. In the remaining trial one participant in the intervention group and one in the control group were lost to follow-up. However, the outcomes of these two participants were not described. Postoperative adjuvant chemotherapy versus no postoperative adjuvant chemotherapy We are very uncertain as to whether postoperative adjuvant chemotherapy has little to no effect on all-cause mortality versus no postoperative adjuvant chemotherapy (RR 0.92, 95% CI 0.84 to 1.01; 4 trials, 867 participants, very low-certainty evidence). We are very uncertain of the effect of postoperative adjuvant chemotherapy on serious adverse events (RR 17.82, 95% CI 2.43 to 130.82; 1 trial, 219 participants, very low-certainty evidence). The trial indicated that postoperative adjuvant chemotherapy could increase serious adverse events, as 19/113 (20.5%) of participants developed an adverse event, compared to 1/106 (1.1%) of participants in the no-postoperative adjuvant chemotherapy group. None of the included trials reported data on health-related quality of life, cancer-related mortality, time to recurrence of the tumour, and non-serious adverse events in participants with only cholangiocarcinoma. Adjuvant S-1 chemotherapy (fluoropyrimidine derivative) versus adjuvant gemcitabine-based chemotherapy The only available trial analysed all participants with intrahepatic, perihilar cholangiocarcinoma and gallbladder carcinoma together, with data on participants with cholangiocarcinoma not provided separately. The authors reported that one-year overall mortality after adjuvant S-1 therapy was lower than with adjuvant gemcitabine-based therapy following major hepatectomy for biliary tract cancer. There were no differences in two-year overall mortality. FUNDING: two trials received support from drug companies; one trial received funding from the Japan Society of Clinical Oncology; one trial received support from "Programme Hospitalier de Recherche Clinique (PHRC2009) and Ligue Nationale Contre le Cancer"; and one trial did not provide information on support or sponsorship. We identified six ongoing randomised clinical trials. AUTHORS' CONCLUSIONS: Based on the very low-certainty evidence found in four trials in people with curative-intent resection for cholangiocarcinoma, we are very uncertain of the effects of postoperative adjuvant chemotherapy (mitomycin-C and 5-FU; gemcitabine; gemcitabine plus oxaliplatin; or capecitabine) versus no postoperative adjuvant chemotherapy on mortality. The effects of postoperative adjuvant chemotherapy compared with no postoperative adjuvant chemotherapy on serious adverse events are also very uncertain, but the result of the single trial showed 20% higher occurrences of haematologic adverse events. We assessed the certainty of the evidence as very low due to overall high risk of bias, and imprecision. Due to insufficient power of the only identified trial, the best postoperative adjuvant chemotherapy regimen in people with only cholangiocarcinoma could not be established. We also lack randomised clinical trials with outcome data on adjuvant S-1 chemotherapy versus adjuvant gemcitabine-based chemotherapy in people with cholangiocarcinoma alone. There is a need for further randomised clinical trials designed to be at low risk of bias and with adequate sample size exploring the best adjuvant chemotherapy treatment after surgery in people with cholangiocarcinoma.

Postoperative interventions for preventing bladder dysfunction after radical hysterectomy in women with early-stage cervical cancer.

BACKGROUND: Bladder dysfunction is a common complication following radical hysterectomy, caused by the damage to pelvic autonomic nerves that innervate the muscles of the bladder, urethral sphincter, and pelvic floor fasciae. Bladder dysfunction increases the rates of urinary tract infection, hospital visits or admission, and patient dissatisfaction. In addition, bladder dysfunction can also negatively impact patient quality of life (QoL). Several postoperative interventions have been proposed to prevent bladder dysfunction following radical hysterectomy. To our knowledge, there has been no systematic review evaluating the effectiveness and safety of these interventions for preventing bladder dysfunction following radical hysterectomy in women with cervical cancer. OBJECTIVES: To evaluate the effectiveness and safety of postoperative interventions for preventing bladder dysfunction following radical hysterectomy in women with early-stage cervical cancer (stage IA2 to IIA2). SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 4) in the Cochrane Library, MEDLINE via Ovid (1946 to April week 2, 2020), and Embase via Ovid (1980 to 2020, week 16). We also checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effectiveness and safety of any type of postoperative interventions for preventing bladder dysfunction following a radical hysterectomy in women with stage IA2 to IIA2 cervical cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgments on the quality and certainty of the evidence. We resolved any disagreements through discussion or consultation with a third review author. Outcomes of interest consisted of spontaneous voiding recovery one week after the operation, quality of life (QoL), adverse events, post-void residual urine volume one month after the operation, urinary tract infection over the one month following the operation, and subjective urinary symptoms. MAIN RESULTS: We identified 1464 records as a result of the search (excluding duplicates). Of the 20 records that potentially met the review criteria, we included five reports of four studies. Most of the studies had unclear risks of selection and reporting biases. Of the four studies, one compared bethanechol versus placebo and three studies compared suprapubic catheterisation with intermittent self-catheterisation. We identified two ongoing studies. Bethanechol versus placebo The study reported no information on the rate of spontaneous voiding recovery at one week following the operation, QoL, adverse events, urinary tract infection in the first month after surgery, and subjective urinary symptoms for this comparison. The volume of post-void residual urine, assessed at one month after surgery, among women receiving bethanechol was lower than those in the placebo group (mean difference (MD) -37.4 mL, 95% confidence interval (CI) -60.35 to -14.45; one study, 39 participants; very-low certainty evidence). Suprapubic catheterisation versus intermittent self-catheterisation The studies reported no information on the rate of spontaneous voiding recovery at one week and post-void residual urine volume at one month following the operation for this comparison. There was no difference in risks of acute complication (risk ratio (RR) 0.77, 95% CI 0.24 to 2.49; one study, 71 participants; very low certainty evidence) and urinary tract infections during the first month after surgery (RR 0.77, 95% CI 0.53 to 1.13; two studies, 95 participants; very- low certainty evidence) between participants who underwent suprapubic catheterisation and those who underwent intermittent self-catheterisation. Available data were insufficient to calculate the relative measures of the effect of interventions on QoL and subjective urinary symptoms. AUTHORS' CONCLUSIONS: None of the included studies reported rate of spontaneous voiding recovery one week after surgery, time to a post-void residual volume of urine of 50 mL or less, or post-void residual urine volume at 6 and 12 months after surgery, all of which are important outcomes for assessing postoperative bladder dysfunction. Limited evidence suggested that bethanechol may minimise the risk of bladder dysfunction after radical hysterectomy by lowering post-void residual urine volume. The certainty of this evidence, however, was very low. The effectiveness of different types of postoperative urinary catheterisation (suprapubic and intermittent self-catheterisation) remain unproven.

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.

Nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa).

BACKGROUND: Radical hysterectomy is one of the standard treatments for stage Ia2 to IIa cervical cancer. Bladder dysfunction caused by disruption of the pelvic autonomic nerves is a common complication following standard radical hysterectomy and can affect quality of life significantly. Nerve-sparing radical hysterectomy is a modified radical hysterectomy, developed to permit resection of oncologically relevant tissues surrounding the cervical lesion, while preserving the pelvic autonomic nerves. OBJECTIVES: To evaluate the benefits and harms of nerve-sparing radical hysterectomy in women with stage Ia2 to IIa cervical cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid (1946 to May week 2, 2018), and Embase via Ovid (1980 to 2018, week 21). We also checked registers of clinical trials, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the efficacy and safety of nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa). DATA COLLECTION AND ANALYSIS: We applied standard Cochrane methodology for data collection and analysis. Two review authors independently selected potentially relevant RCTs, extracted data, evaluated risk of bias of the included studies, compared results and resolved disagreements by discussion or consultation with a third review author, and assessed the certainty of evidence. MAIN RESULTS: We identified 1332 records as a result of the search (excluding duplicates). Of the 26 studies that potentially met the review criteria, we included four studies involving 205 women; most of the trials had unclear risks of bias. We identified one ongoing trial.The analysis of overall survival was not feasible, as there were no deaths reported among women allocated to standard radical hysterectomy. However, there were two deaths in among women allocated to the nerve-sparing technique. None of the included studies reported rates of intermittent self-catheterisation over one month following surgery. We could not analyse the relative effect of the two surgical techniques on quality of life due to inconsistent data reported. Nerve-sparing radical hysterectomy reduced postoperative bladder dysfunctions in terms of a shorter time to postvoid residual volume of urine ≤ 50 mL (mean difference (MD) -13.21 days; 95% confidence interval (CI) -24.02 to -2.41; 111 women; 2 studies; low-certainty evidence) and lower volume of postvoid residual urine measured one month following operation (MD -9.59 days; 95% CI -16.28 to -2.90; 58 women; 2 study; low-certainty evidence). There were no clear differences in terms of perioperative complications (RR 0.55; 95% CI 0.24 to 1.26; 180 women; 3 studies; low-certainty evidence) and disease-free survival (HR 0.63; 95% CI 0.00 to 106.95; 86 women; one study; very low-certainty evidence) between the comparison groups. AUTHORS' CONCLUSIONS: Nerve-sparing radical hysterectomy may lessen the risk of postoperative bladder dysfunction compared to the standard technique, but the certainty of this evidence is low. The very low-certainty evidence for disease-free survival and lack of information for overall survival indicate that the oncological safety of nerve-sparing radical hysterectomy for women with early stage cervical cancer remains unclear. Further large, high-quality RCTs are required to determine, if clinically meaningful differences of survival exist between these two surgical treatments.

Interventions for intra-operative pain relief during postpartum mini-laparotomy tubal ligation.

BACKGROUND: Postpartum mini-laparotomy tubal ligation (PPTL) is a contraceptive method that works by interrupting the patency of the fallopian tubes. Several methods are used for intraoperative pain relief, such as systemic administration of opioids or intraperitoneal instillation of lidocaine. OBJECTIVES: To evaluate the effectiveness of and adverse effects associated with interventions for pain relief in women undergoing PPTL. SEARCH METHODS: We searched for eligible studies published on or before 31 July 2017 in the CENTRAL Register of Studies Online, MEDLINE, Embase, PsycINFO, and CINAHL. We examined review articles and searched registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCT) that compared perioperative pain relief measures during PPTL. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the titles, abstracts, and full-text articles of potentially relevant studies for inclusion. We extracted the data from the included studies, assessed risk of bias, and calculated and compared results. Discrepancies were resolved by discussion, or by consulting a third review author. We computed the inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes, and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: We found only three RCTs, in which a total of 230 postpartum women participated. Most of our analyses were based on relatively small numbers of patients and studies. Overall, the certainty of evidence regarding the effectiveness of interventions was low, due to risk of bias and imprecision. We found very low-certainty evidence regarding the safety of interventions because of risk of bias and imprecision. Two studies had unclear risk of selection bias. One study had unclear risk of reporting bias and a high risk of other bias associated with the study protocol.Women who received an intraperitoneal instillation of lidocaine experienced lower intensity intraperitoneal pain than those given a placebo (pooled MD -3.34, 95% CI -4.19 to -2.49, three studies, 190 participants, low-certainty evidence), or an intramuscular injection of morphine (MD -4.8, 95% CI -6.43 to -3.17, one study, 40 participants, low-certainty evidence). We found no clear difference in intraperitoneal pain between women who had an intramuscular injection of morphine added to an intraperitoneal instillation of lidocaine and those who had an intraperitoneal instillation of lidocaine alone (MD -0.40, 95% CI -1.52 to 0.72, one study, 40 participants, low-certainty evidence). An intramuscular injection of morphine alone was not effective for intraperitoneal pain relief compared to placebo (MD 0.50, 95% CI -1.33 to 2.33, one study, 40 women, low-certainty evidence). None of the studies reported any serious adverse events but the evidence was very low-certainty. Intraperitoneal instillation of lidocaine may reduce the number of women requiring additional pain control when compared to placebo (RR 0.27, 95% CI 0.17 to 0.44, three studies, 190 women, low-certainty evidence). AUTHORS' CONCLUSIONS: An intraperitoneal instillation of lidocaine during postpartum mini-laparotomy tubal ligation before fallopian tubes were tied may offer better intraperitoneal pain control, although the evidence regarding adverse effects is uncertain. We found no clear difference in intraperitoneal pain between women who received a combination of an injection of morphine, and intraperitoneal instillation of lidocaine and those who received an intraperitoneal instillation of lidocaine alone. These results must be interpreted with caution, since the evidence overall was low to very low-certainty.

Management of drainage for malignant ascites in gynaecological cancer.

BACKGROUND: Ascites is the accumulation of fluid within the abdominal cavity. Most women with advanced ovarian cancer and some women with advanced endometrial cancer need repeated drainage for ascites. Guidelines to advise those involved in the drainage of ascites are usually produced locally and are generally not evidence-based. Managing drains that improve the efficacy and quality of the procedure is key in making recommendations that could improve the quality of life (QoL) for women at this critical period of their lives. OBJECTIVES: To evaluate the effectiveness and adverse events of different interventions for the management of malignant ascites drainage in the palliative care of women with gynaecological cancer. SEARCH METHODS: We searched CENTRAL, MEDLINE, and Embase to 4 November 2019. We checked clinical trial registries, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of women with malignant ascites with gynaecological cancer. If studies also included women with non-gynaecological cancer, we planned to extract data specifically for women with gynaecological cancers or request the data from trial authors. If this was not possible, we planned to include the study only if at least 50% of participants were diagnosed with gynaecological cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data, evaluated the quality of the included studies, compared results, and assessed the certainty of the evidence using Cochrane methodology. MAIN RESULTS: In the original 2010 review, we identified no relevant studies. This updated review included one RCT involving 245 participants that compared abdominal paracentesis and intraperitoneal infusion of catumaxomab versus abdominal paracentesis alone. The study was at high risk of bias in almost all domains. The data were not suitable for analysis. The median time to the first deterioration of QoL ranged from 19 to 26 days in participants receiving paracentesis alone compared to 47 to 49 days among participants receiving paracentesis with catumaxomab infusion (very low-certainty evidence). Adverse events were only reported among participants receiving catumaxomab infusion. The most common severe adverse events were abdominal pain and lymphopenia (157 participants; very low-certainty evidence). There were no data on the improvement of symptoms, satisfaction of participants and caregivers, and cost-effectiveness. AUTHORS' CONCLUSIONS: Currently, there is insufficient evidence to recommend the most appropriate management of drainage for malignant ascites among women with gynaecological cancer, as there was only very low-certainty evidence from one small RCT at overall high risk of bias.

Extended-field radiotherapy for locally advanced cervical cancer.

BACKGROUND: The para-aortic lymph nodes (located along the major vessels in the mid and upper abdomen) are a common place for disease recurrence after treatment for locally advanced cervical cancer. The para-aortic area is not covered by standard pelvic radiotherapy fields and so treatment to the pelvis alone is inadequate for women at a high risk of occult cancer within para-aortic lymph nodes. Extended-field radiotherapy (RT) widens the pelvic RT field to include the para-aortic lymph node area. Extended-field RT may improve outcomes in women with locally advanced cervical cancer by treating occult disease in para-aortic nodes not identified at pretreatment imaging. However, RT treatment of the para-aortic area can cause severe adverse effects, so may increase harms.Studies of pelvic chemoradiotherapy (CRT) demonstrated improved survival rates compared to pelvic RT alone. CRT is now the standard of care in the treatment of locally advanced cervical cancer. Studies comparing pelvic RT alone (without concurrent chemotherapy) with extended-field RT should therefore be viewed with caution, since they compare treatments against what is now substandard treatment (pelvic RT alone). This review should therefore be read with this in mind and comparisons with pelvic RT cannot be extrapolated to pelvic CRT. OBJECTIVES: To evaluate the effectiveness and toxicity of extended-field radiotherapy in women undergoing first-line treatment for locally advanced cervical cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7), MEDLINE via Ovid (1946 to August week 4, 2018), and Embase via Ovid (1980 to 2018, week 35). We checked registers of clinical trials, grey literature, conference reports, and citation lists of included studies to August 2018. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effectiveness and toxicity of extended-field RT for locally advanced cervical cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently selected potentially relevant RCTs, extracted data, assessed risk of bias, compared results, and made judgements on the quality and certainty of the evidence for each outcome. Any disagreements were resolved by discussion or consultation with a third review author. MAIN RESULTS: Five studies met the inclusion criteria. Three included studies compared extended-field RT versus pelvic RT, one included study compared extended-field RT with pelvic CRT, and one study compared extended-field CRT versus pelvic CRT.Extended-field radiotherapy versus pelvic radiotherapy aloneCompared to pelvic RT, extended-field RT probably reduces the risk of death (hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.48 to 0.94; 1 study; 337 participants; moderate-certainty evidence) and para-aortic lymph node recurrence (risk ratio (RR) 0.36, 95% CI 0.18 to 0.70; 2 studies; 477 participants; moderate-certainty evidence), although there may or may not have been improvement in the risk of disease progression (HR 0.92, 95% CI 0.69 to 1.22; 1 study; 337 participants; moderate-certainty evidence) and severe adverse events (RR 1.05, 95% CI 0.79 to 1.41; 2 studies; 776 participants; moderate-certainty evidence).Extended-field radiotherapy versus pelvic chemoradiotherapyIn a comparison of extended-field RT versus pelvic CRT, women given pelvic CRT probably had a lower risk of death (HR 0.50, 95% CI 0.39 to 0.64; 1 study; 389 participants; moderate-certainty evidence) and disease progression (HR 0.52, 95% CI 0.37 to 0.72; 1 study; 389 participants; moderate-certainty evidence). Participants given extended-field RT may or may not have had a lower risk of para-aortic lymph node recurrence (HR 0.44, 95% CI 0.20 to 0.99; 1 study; 389 participants; low-certainty evidence) and acute severe adverse events (RR 0.05, 95% CI 0.02 to 0.11; 1 study; 388 participants; moderate-certainty evidence). There were no clear differences in terms of late severe adverse events among the comparison groups (RR 1.06, 95% CI 0.69 to 1.62; 1 study; 386 participants; moderate-certainty evidence).Extended-field chemoradiotherapy versus pelvic chemoradiotherapyVery low-certainty evidence obtained from one small study (74 participants) showed that, compared to pelvic CRT, extended-field CRT may or may not have reduced risk of death (HR 0.37, 95% CI 0.14 to 0.96) and disease progression (HR 0.25, 95% CI 0.07 to 0.87). There were no clear differences between the groups in the risks of para-aortic lymph node recurrence (RR 0.19, 95% CI 0.02 to 1.54; very low-certainty evidence) and severe adverse events (acute: RR 0.95, 95% CI 0.20 to 4.39; late: RR 0.95, 95% CI 0.06 to 14.59; very low-certainty evidence). AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that, compared with pelvic RT alone, extended-field RT probably improves overall survival and reduces risk of para-aortic lymph node recurrence. However, pelvic RT alone would now be considered substandard treatment, so this result cannot be extrapolated to modern standards of care. Low- to moderate-certainty evidence suggests that pelvic CRT may increase overall and progression-free survival compared to extended-field RT, although there may or may not be a higher rate of para-aortic recurrence and acute adverse events. Extended-field CRT versus pelvic CRT may improve overall or progression-free survival, but these findings should be interpreted with caution due to very low-certainty evidence.High-quality RCTs, comparing modern treatment techniques in CRT, are needed to more fully inform treatment for locally advanced cervical cancer without obvious para-aortic node involvement.

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.

Antibiotics for infection prevention after excision of the cervical transformation zone.

BACKGROUND: Excision of the transformation zone of the cervix is the most commonly used approach to treat cervical precancerous lesions (cervical intraepithelial neoplasia (CIN)) to reduce the risk of developing cervical cancer. As the excision of the transformation zone leaves a raw area on the cervix, there is a risk of infection following the procedure. The incidence of infection after cold knife conization (CKC) is 36%, whereas the incidence for large loop excision of the transformation zone (LLETZ, also known as loop electrical excision procedure (LEEP)) is much lower (0.8% to 14.4%). Prophalytic antibiotics may prevent an infection developing and are often prescribed for CKC. However, there are no formal recommendations regarding the use of prophylactic antibiotics for infection prevention in women undergoing surgical excisional treatment for cervical precancerous lesions. OBJECTIVES: To evaluate the effectiveness and safety of antibiotics for infection prevention following excision of the cervical transformation zone. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2016, Issue 4), MEDLINE, Embase, LILACS to May 2016. We also checked registers of clinical trials, citation lists of included studies, key textbooks and previous systematic reviews for potentially relevant studies SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effectiveness and safety of prophylactic antibiotics versus a placebo or no treatment in women having excision of the cervical transformation zone, regardless of the type of surgical excisional method used. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently selected potentially relevant trials, extracted data, and assessed risk of bias, compared results and resolved disagreements by discussion. We contacted investigators for additional data, where possible. MAIN RESULTS: Of the 370 records that we identified as a result of the search (excluding duplicates), we regarded six abstracts and titles as potentially relevant studies. Of these six studies, three met the inclusion criteria involving 708 participants; most trials were at moderate or high risk of bias (risk mainly due to lack of blinding and high rate of incomplete data). We did not identify any ongoing trials. Although all included studies had been published in peer-reviewed journals at the time of the search and data extraction, numerical data regarding the outcome measured in one trial involving 77 participants were insufficient for inclusion in a meta-analyses.The difference in the rates of prolonged vaginal discharge or presumed cervicitis (one study; 348 participants; risk ratio (RR), 1.29; 95% confidence interval (CI) 0.72 to 2.31; low-quality evidence) and severe vaginal bleeding (two studies; 638 participants; RR 1.21; 95% CI 0.52 to 2.82; very low-quality evidence) among the two comparison groups did not reach the level for clinically important effect. In addition, there was no difference in adverse events related to antibiotics i.e. nausea/vomiting, diarrhoea, and headache among the two comparison groups (two studies; 638 participants; RR 1.69; 95% CI 0.85 to 3.34; very low-quality evidence). There were no differences in the incidence of fever (RR, 2.23; 95% CI 0.20 to 24.36), lower abdominal pain (RR, 1.03; 95% CI 0.61 to 1.72), unscheduled medical consultation (RR 2.68, 95% CI 0.97 to 7.41), and additional self-medication (RR 1.22; 95% CI 0.56 to 2.67) between the two comparison groups (one study; 290 participants; low to very low-quality evidence). AUTHORS' CONCLUSIONS: As only limited data are available from three trials with overall moderate to high risk of bias, there is insufficient evidence to support use of antibiotics to reduce infectious complications following excision of the cervical transformation zone. In addition, there were minimal data about antibiotic-related adverse events and no information on the risk of developing antibiotic resistance. Antibiotics given for infection prevention after excision of the cervical transformation zone should only be used in the context of clinical research, to avoid unnecessary prescription of antibiotics and to prevent further increases in antibiotic resistance.

Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer.

BACKGROUND: Ovarian cancer is the third most common gynaecological cancer worldwide, with an age-standardised incidence rate of 6.1 per 10,000 women. Standard therapy for advanced epithelial ovarian cancer (EOC) includes a combination of cytoreductive surgery and platinum-based chemotherapy. Cytoreductive surgery aims to remove as much of the visible tumour as possible. As extensive intraperitoneal metastases are typical of advanced EOC, cytoreductive surgery is usually an extensive procedure with the risk of excessive bleeding. Tranexamic acid given perioperatively is effective in reducing blood loss and allogeneic blood transfusion requirements in a variety of surgical settings. Therefore, tranexamic acid seems to be a promising agent for minimising blood loss and the need for blood transfusion among women with advanced EOC undergoing cytoreductive surgery. OBJECTIVES: To assess the effects of tranexamic acid for reducing blood loss associated with cytoreductive surgery in women with advanced EOC (stage III to IV). SEARCH METHODS: We searched the Cochrane Gynaecological, Neuro-oncology and Orphan Cancers Trial Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 5, 2015), MEDLINE, EMBASE and conference proceedings to May 2015. We also checked registers of clinical trials, citation lists of included studies, key textbooks and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing tranexamic acid given during surgery versus placebo or no treatment, in adult women diagnosed with advanced EOC. DATA COLLECTION AND ANALYSIS: Two review authors (CK, AS) independently selected potentially relevant trials, extracted data, assessed risk of bias, compared results and resolved disagreements by discussion. MAIN RESULTS: We found only one study that met our inclusion criteria. This was a randomised double blind, placebo-controlled multicentre study conducted to evaluate the effectiveness of a single dose of intravenous tranexamic acid (15 mg/kg body weight) versus placebo, given immediately before surgery for reducing blood loss and the need for red blood cell transfusion. The mean total estimated blood loss was 668.34 mL and 916.93 mL for participants assigned to tranexamic acid and placebo groups, respectively. The mean difference (MD) of total estimated blood loss between the groups did not show a clinically important effect (MD - 248.59 mL; 95% confidence interval (CI) - 550.9 to 53.79; one study, 100 participants; moderate quality evidence). The mean number of transfused units of blood components was not different between the two groups (low quality evidence). There were no noted differences in the incidence of reoperation, readmission or thromboembolic events (very low quality evidence). We considered the methodology of the included study to be at low risk of selection, detection, and reporting biases. However, we were concerned about an imbalance of some baseline characteristics between the groups, and as there was no protocol for blood transfusion, the rate of blood transfusion may vary depending on the practice of each participating hospital. AUTHORS' CONCLUSIONS: Currently, there is insufficient evidence to recommend the routine use of tranexamic acid for reducing blood loss in women undergoing cytoreductive surgery for advanced EOC, as only limited data are available from a single, low quality RCT at low overall risk of bias.

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.

Survival and prognostic factors of patients with primary fallopian tube cancer receiving adjuvant paclitaxel and carboplatin chemotherapy.

AIM: To determine the survival and prognostic factors of patients with primary fallopian tube cancer (PFTC) who had been treated with paclitaxel and carboplatin chemotherapy. METHODS: The records of patients with PFTC who had been treated between 2002 and 2010, identified through the report of Chiang Mai University Hospital, were reviewed. All patients had pathological materials initially reported or reviewed by a gynecologic pathologist before initiation of treatment. RESULTS: Thirty patients met the inclusion criteria. Median age was 51 years. Serous adenocarcinoma was observed in the majority of patients (76.7%). Approximately 46% of patients were in stage I­II. The 5-year progression-free survival (PFS) for all patients was 37.2%. The 5-year PFS was 75.0% for stage I, 51.4% for stage II and 18.5% for stage III. Median PFS of the entire cohort was 26.0 months with a 95% confidence interval (CI) of 18.7­33.3 months. This rate was 18.5 months (95% CI, 6.7­35.6) for stage III whereas it was not reached for patients of stage I­II. Serous histology and stage were noted to be significant independent predictors of PFS with an adjusted hazards ratio of 7.54 (95% CI, 1.34­42.4) and 6.19 (95% CI, 1.59­24.08), respectively. CONCLUSION: The 5-year PFS of the whole cohort was 37.2% with a median survival of 26 months. International Federation of Gynecology and Obstetrics stage and histological subtype were a significant independent factor for predicting PFS.

Depot medroxyprogesterone acetate and endometrial cancer: A multicenter case-control study.

OBJECTIVE: To assess the associations between depot medroxyprogesterone acetate (DMPA) and endometrial cancer. METHODS: This multicenter case-control study was conducted among tertiary hospitals in Thailand. Patients were women with endometrial cancer. Controls were women admitted for other conditions, matched for age within 5 years of the patients' age. The controls had to have no abnormal vaginal bleeding, history of hysterectomy, or cancers of the other organs. A standardized questionnaire was used to gather information. Conditional logistic regression was applied to calculate adjusted odds ratio (aORs) and 95% confidence intervals (CIs). RESULTS: During 2015 to 2021, 378 patients and 1134 controls were included. Ever use of DMPA was associated with a 70% decreased overall risk of endometrial cancer (aOR, 0.30 [95% CI, 0.21-0.42]). Endometrial cancer risk declined by 3% (aOR, 0.97 [95% CI, 0.96-0.98]) for every 3 months of DMPA use. The magnitude of the decline in endometrial cancer risk did not vary appreciably by cancer subtypes (aOR, 0.26 [95% CI, 0.17-0.41] and 0.38 [95% CI, 0.22-0.65] for low-grade and high-grade tumors, respectively). CONCLUSIONS: Depot medroxyprogesterone acetate use was inversely associated with endometrial cancer risk in a duration-dependent manner. This association was independent of cancer subtype.

Review of postpartum contraceptive practices at Chiang Mai University Hospital: implications for improving quality of service.

OBJECTIVE: To evaluate the acceptance rate and patterns of contraceptive use among postpartum women. SUBJECTS AND METHODS: The records of 1,009 postpartum women attending the Family Planning Clinic at Chiang Mai University Hospital, Thailand, during January to December 2009 were reviewed. RESULTS: Mean age was 28.2 ± 5.7 years (range 15-48). Almost all 920 women (91.2%) practiced breastfeeding. The acceptance rate of contraception was 97.6%. The types of contraceptive used were: depot medroxyprogesterone acetate, 387 (38.4%); progestin-only pills, 262 (26.0%); tubal resection, 201 (19.9%); male condom, 78 (7.7%); oral combined pills, 49 (4.9%); intrauterine device, 5 (0.5%); implant, 3 (0.3%). Among women undergoing tubal resection, 29 (14.4%) were ≤24 years of age. Significant independent predictors for using long-acting reversible contraception were young age and little or no formal education. CONCLUSION: The acceptance rate of contraception in this study was high. However, the following issues need to be evaluated: compliance of women using progestin-only pills, awareness of long-acting reversible contraception as an alternative option in women considering sterilization, and interventions to promote the use of intrauterine devices and implants.

Evaluation of mobile health applications for cervical cancer in the digital marketplace.

OBJECTIVE: To assess the quality of mobile health (mHealth) applications (apps) for cervical cancer using the mobile app rating scale (MARS), APPLICATIONS scoring system, and app rating using specific statements. METHODS: We searched for cervical cancer apps on two major mobile operating systems (Google Play Store and Apple iTunes Store) in March 2021. Eligible apps were downloaded and assessed for quality by two independent reviewers using multimodal assessment tools. RESULTS: The overall quality of the MARS score was 2.61±0.795. The highest scoring app was "The American Society for Colposcopy and Cervical Pathology (ASCCP) Management Guidelines" (3.98). Overall, apps scored highest in the functionality domain, followed by information, engagement, and aesthetics domains. The mean±standard deviation of the APPLICATIONS scoring system was 8.50±1.712. The highest-rated apps were "ASCCP Management Guidelines," "The British Society for Colposcopy and Cervical Pathology (BSCCP)," and "Cervical Cancer Guide." Apps scored the highest in the paid subscription and price domains. By contrast, apps scored poorly in the text search, literature, and subjective presentation domains. Concerning app content, many apps infrequently provided misconceptions regarding cervical cancer. The apps' rating using specific statements was 7.81±4.562. CONCLUSION: Overall, the apps analyzed using the MARS and APPLICATIONS scoring systems demonstrated above-average quality. However, there is a need to improve the essential information conveyed by these applications. Moreover, the assessment tools have influenced different app quality rating results, confirming the lack of standardized quality assessment tools for mHealth apps.

Clinical significance of atypical glandular cells on Pap smears: experience from a region with a high incidence of cervical cancer.

AIM: To evaluate the histopathology of women who had atypical glandular cells (AGC) on Pap smears in a region with high incidence of cervical cancer. MATERIAL AND METHODS: This study was conducted at Chiang Mai University Hospital, Chiang Mai, Thailand. All women with AGC who underwent colposcopic and histopathologic evaluation between January 2002 and December 2008 were reviewed. Women with simultaneous diagnosis of squamous cell abnormality or prior history of cancer of any type were excluded. RESULTS: Sixty-three women with AGC Pap test had histologic follow-up during the study period. Mean age was 44.9 years (range, 31-72 years). Six (9.5%) women were nulliparous. Sixteen (25.4%) women were postmenopausal. The histopathologic results of these 63 women were as follows: cervical intraepithelial neoplasia (CIN) 2-3, 5 (7.9%); adenocarcinoma in situ (AIS), 3 (4.8%); endometrial cancer, 3 (4.8%); cervical cancer, 2 (3.2%); endometrial hyperplasia (EH), 1 (1.6%); and no lesions, 49 (77.8%). The prevalence of significant lesions (CIN 2-3, AIS, EH, and cancer) in women with atypical glandular cells, favor neoplasia (AGC-FN) was significantly higher than that in the atypical glandular cells, not other specified (AGC-NOS) group (41.2% and 15.2%, P = 0.02). CONCLUSION: Reporting AGC in our population is clinically significant due to the high prevalence of underlying preinvasive and invasive diseases (22.2%). This subtype of the AGC category is a significant predictor of such lesions.

Preceding cervical cytology in women with high-grade squamous intraepithelial lesion.

OBJECTIVE: To evaluate the preceding cervical cytology and factors leading to cytohistologic discrepancy in women with high-grade squamous intraepithelial lesion (HSIL) histology. METHODS: The records of women who were found to have histologically confirmed HSIL without any associated invasive and glandular lesions, at Chiang Mai University Hospital between January 2005 and May 2009, were reviewed. Cytohistological discrepancy was defined as HSIL histology preceded by low-grade squamous intraepithelial lesion (LSIL) and atypical squamous cells of undetermined significance (ASC-US) smears. RESULTS: The records of 436 HSIL cases were reviewed. The mean age of the women was 45.0 ± 9.3 years. The preceding smear abnormalities were as follows: 275 (63.1%) with HSIL; 50 (11.5%) with atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H); 40 (9.2%) with squamous cell carcinoma; 35 (8.0%) with LSIL; 32 (7.3%) with ASC-US; and 4 (0.9) with glandular abnormality smears. Overall, the rate of cytohistological discrepancy was 15.4% (95% CI 12.1-19.1%). The small size of HSIL and presence of coexisting LSIL are significant independent predictors for cytohistologic discrepancy. CONCLUSION: Approximately 15% of HSIL cases are under-diagnosed by cytology. Significant factors leading to cytohistologic discrepancy are lesion size and the presence of coexisting LSIL.

Changing gloves during cesarean section for prevention of postoperative infections: a systematic review and meta-analysis.

This systematic review and meta-analysis was conducted to assess associations between changing gloves during cesarean section (CS) and postoperative infection. A literature search was conducted using the major electronic databases MEDLINE, Scopus, ISI Web of Science, PubMed, CINAHL, and CENTRAL from their inception to September 2020. Randomized controlled trials (RCTs) comparing glove change during CS to no glove change were included. Outcomes of interest were endometritis, febrile morbidity, and incisional surgical site infection (SSI). GRADE approach was applied to assess the quality of evidence. Ten reports of six studies involving 1707 participants were included in the analyses. Glove change was associated with a reduction in the risk of incisional SSI following CS (pooled RR 0.49, 95% CI 0.30, 0.78; moderate quality of evidence). Compared to no glove change, glove change during CS did not reduce the risks of endometritis (pooled RR 1.00, 95% CI 0.80, 1.24; low quality of evidence) or febrile morbidity (pooled RR 0.85, 95% CI 0.43, 1.71; very low quality of evidence). Changing gloves during CS was associated with a decreased risk of incisional SSI. The risks of postoperative endometritis and febrile morbidity were not altered by changing gloves.

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

BACKGROUND: 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 STRATEGY: We searched the Cochrane Gynaecological Cancer Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 2, 2009) in The Cochrane Library, electronic databases (MEDLINE, EMBASE), and the citation lists of relevant publications. The latest searches were performed on 14 May 2009. 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 weighted mean difference (WMD) and 95% CI. MAIN RESULTS: 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). 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.