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Risk-Reducing Salpingectomy Versus Standard Tubal Sterilization: Lessons From Offering Women Options for Interval Sterilization.

ABSTRACT: OBJECTIVES:In women receiving sterilization, the removal of the entire fallopian tube, a procedure referred to as a risk-reducing salpingectomy (RRS), reduces subsequent ovarian cancer risk compared with standard tubal sterilization procedures. There are limited data on which surgical procedure women will choose when educated about the benefits of an RRS. Our objective was to study the proportion of women desiring sterilization that would choose an RRS. METHODS:This cohort study included women 30 years of age and older with a living biological child who requested laparoscopic sterilization at a tertiary academic hospital. Participants were given a decision aid and offered an RRS or a standard tubal sterilization procedure with titanium clips. The primary outcome was to determine the proportion of women who would choose an RRS. Other outcomes included estimated blood loss and operative time, which was compared between groups, along with complications. RESULTS:Fourteen of the 18 (78%) women who participated in our study chose RRS. Estimated blood loss and operating time were similar among women who underwent RRS and standard tubal sterilizations. There were no significant complications in either group. The study was ended early based on emerging data and a change in national practice patterns. CONCLUSIONS:Because of the elective nature of sterilization and the complexities of cancer risk reduction, a patient-centered approach is beneficial for sterilization counseling. Our results support offering RRS as an alternative to standard tubal sterilization.

SUBMITTER: Zerden ML

PROVIDER: S-EPMC6419963 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Risk-Reducing Salpingectomy Versus Standard Tubal Sterilization: Lessons From Offering Women Options for Interval Sterilization.

Zerden Matthew L ML Castellano Tara T Doll Kemi M KM Stuart Gretchen S GS Munoz M Cris MC Boggess Kim A KA

Southern medical journal 20180301 3

<h4>Objectives</h4>In women receiving sterilization, the removal of the entire fallopian tube, a procedure referred to as a risk-reducing salpingectomy (RRS), reduces subsequent ovarian cancer risk compared with standard tubal sterilization procedures. There are limited data on which surgical procedure women will choose when educated about the benefits of an RRS. Our objective was to study the proportion of women desiring sterilization that would choose an RRS.<h4>Methods</h4>This cohort study i ...[more]

PMID: 29505655

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Project description:OBJECTIVE:To evaluate the feasibility of salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility. METHODS:We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided ? of 0.05. Analysis was by intent to treat. RESULTS:Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups. CONCLUSION:Adding 15 minutes to total operative times, salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery. CLINICAL TRIAL REGISTRATION:Clinicaltrials.gov, NCT02374827.

Project description:OBJECTIVE:To compare the natural fertility outcomes of salpingotomy and salpingectomy among women treated for tubal pregnancy. METHODS:An online database search including PubMed, Embase, CENTRAL and Web of Science was performed to identify studies comparing salpingotomy and salpingectomy to treat women with tubal pregnancy. The search included papers published after the databases were established until May 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria and then extracted data and assessed the methodological quality of all of the included studies. The meta-analysis was conducted using RevMan 5.3 software. The registration number is CRD42015017545 in PROSPERO. RESULTS:Two randomized controlled trials (RCTs) and eight cohort studies, including a total of 1,229 patients, were znalyzed. The meta-analysis of the RCT subgroup indicated that there was no statistically significant difference in IUP rates (RR = 1.04, 95% CI = 0.89-1.21, P = 0.61) nor the repeat ectopic pregnancy (REP) rate (RR = 1.30, 95% CI = 0.72-2.38, P = 0.39) between the salpingotomy and salpingectomy group. In contrast, the cohort study subgroup analysis revealed that the IUP rate was higher in the salpingotomy group compared with the salpingectomy group (RR = 1.24, 95% CI = 1.08-1.42, P = 0.002); Salpingotomy also increased the risk of REP rate (RR = 2.27, 95% CI = 1.12-4.58, P = 0.02). The persistent ectopic pregnancy (PEP) occurred more frequently in the salpingotomy group than the salpingectomy group (RR = 11.61, 95% CI = 3.17-42.46, P = 0.0002). An IUP would be more likely to occur after salpingotomy than salpingectomy when the follow-up time was more than 36 months (RR = 1.16, 95% CI = 1.02-1.32, P = 0.03). The IUP rate (RR = 1.13, 95% CI = 1.01-1.26, P = 0.03), and the REP rate (RR = 1.62, 95% CI = 1.02-2.56, P = 0.04) was higher after salpingotomy than salpingectomy among patients from Europe compared with those from America. CONCLUSIONS:Based on the available evidence, we believe that for patients with a healthy contralateral tube operated for tubal pregnancy, the subsequent fertility after salpingectomy and salpingotomy are similar in the long term. The fertility prospects will not be improved via salpingotomy compared with salpingectomy.

Project description:ImportanceTubal sterilization is common, especially among individuals with low income. There is substantial misunderstanding about sterilization among those who have undergone the procedure, suggesting suboptimal decision-making about a method that permanently ends reproductive capacity.ObjectiveTo test the efficacy of a web-based decision aid for improving tubal sterilization decision quality.Design, setting, and participantsThis randomized clinical trial conducted between March 2020 and November 2023 included English- or Spanish-speaking pregnant cisgender women aged 21 to 45 years who had Medicaid insurance and were contemplating tubal sterilization after delivery. Participants were recruited from outpatient obstetric clinics in 3 US cities.InterventionParticipants were randomized 1:1 to usual care (control arm) or to usual care plus a web-based decision aid (MyDecision/MiDecisión) (intervention arm). The aid includes written, audio, and video information about tubal sterilization procedures; an interactive table comparing contraceptive options; values-clarifying exercises; knowledge checks; and a summary report.Main outcomes and measuresThe co-primary outcomes were tubal sterilization knowledge and decisional conflict regarding the contraceptive decision. Knowledge was measured as the percentage of correct responses to 10 true-false items. Decisional conflict was measured using the low-literacy Decision Conflict Scale, with lower scores on a range from 0 to 100 indicating less conflict.ResultsAmong the 350 participants, mean (SD) age was 29.7 (5.1) years. Compared with the usual care group, participants randomized to the decision aid had significantly higher tubal sterilization knowledge (mean [SD] proportion of questions answered correctly, 76.5% [16.9%] vs 55.6% [22.6%]; P < .001) and lower decisional conflict scores (mean [SD], 12.7 [16.6] vs 18.7 [20.8] points; P = .002). The greatest knowledge differences between the 2 groups were for items about permanence, with more participants in the intervention arm answering correctly that tubal sterilization is not easily reversible (90.1% vs 39.3%; odds ratio [OR], 14.2 [95% CI, 7.9-25.4]; P < .001) and that the tubes do not spontaneously "come untied" (86.6% vs 33.7%; OR, 13.0 [95% CI, 7.6-22.4]; P < .001).Conclusions and relevanceMyDecision/MiDecisión significantly improved tubal sterilization decision-making quality compared with usual care only. This scalable decision aid can be implemented into clinical practice to supplement practitioner counseling. These results are particularly important given the recent increase in demand for permanent contraception after the US Supreme Court decision overturning federal abortion protections.Trial registrationClinicalTrials.gov Identifier: NCT04097717.

Project description:The effects on ventricular repolarization-recorded on the electrocardiogram (ECG) as lengthening of the QT interval-of acute tuberculosis and those of standard and alternative antituberculosis regimens are underdocumented. A correction factor (QTc) is introduced to make the QT independent of the heart rate, translating into the slope of the regression line between QT and heart rate being close to zero. ECGs were performed predosing and 1 to 5 h postdosing (month 1, month 2, and end of treatment) around drugs' peak concentration time in tuberculosis patients treated with either the standard 6-month treatment (rifampin and isoniazid for 6 months and pyrazinamide and ethambutol for 2 months; "control") or a test regimen with gatifloxacin, rifampin, and isoniazid given for 4 months (pyrazinamide for the first 2 months) as part of the OFLOTUB study, a randomized controlled trial conducted in five African countries. Drug levels were measured at steady state (month 1) in a subset of patients. We compared treatment effects on the QTc and modeled the effect of individual drugs' maximum concentrations of drug in serum (Cmax) on the Fridericia-corrected QT interval. A total of 1,686 patients were eligible for the correction factor analysis of QT at baseline (mean age, 30.7 years; 27% female). Median heart rate decreased from 96/min at baseline to 71/min at end of treatment, and body temperature decreased from 37.2 to 36.5°C. Pretreatment, the nonlinear model estimated the best correction factor at 0.4081 in between Bazett's (0.5) and Fridericia's (0.33) corrections. On treatment, Fridericia (QTcF) was the best correction factor. A total of 1,602 patients contributed to the analysis of QTcF by treatment arm. The peak QTcF value during follow-up was >480 ms for 21 patients (7 and 14 in the test and control arms, respectively) and >500 ms for 9 patients (5 and 4, respectively), corresponding to a risk difference of -0.9% (95% confidence interval [CI], -2.0% to 2.3%; P = 0.12) and 0.1% (95% CI, -0.6% to 0.9%; P = 0.75), respectively, between the test and control arms. One hundred six (6.6%) patients had a peak measurement change from baseline of >60 ms (adjusted between-arm difference, 0.8%; 95% CI, -1.4% to 3.1%; P = 0.47). No evidence was found of an association between Cmax of the antituberculosis drugs 1 month into treatment and the length of QTcF. Neither a standard 6-month nor a 4-month gatifloxacin-based regimen appears to carry a sizable risk of QT prolongation in patients with newly diagnosed pulmonary tuberculosis. This is to date the largest data set studying the effects of antituberculosis regimens on the QT, both for the standard regimen and for a fluoroquinolone-containing regimen. (This study has been registered at ClinicalTrials.gov under identifier NCT00216385.).

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Risk-Reducing Salpingectomy Versus Standard Tubal Sterilization: Lessons From Offering Women Options for Interval Sterilization.

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Risk-Reducing Salpingectomy Versus Standard Tubal Sterilization: Lessons From Offering Women Options for Interval Sterilization.

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