Richtlijn Sterilisatie van de vrouw - NVOG

ReferentieType studieKenmerken(studie/patiënten)Interventie (I)Uitkomstmaten enfollow-up duurResultatenBeoordelingkwaliteit studieKulier, 2002Cochrane ReviewLangenveld,2008MetaanalysiscomparativeProspectivecohortstudy,published as“casereports”notcomparativeN = 149enrolled,placementwasattempted in143 patientsInclusion criteria:Exclusion criteria:Age (mean/ average/ 95% CI)BMI (mean/ average/ 95% CI)Other relevant demographics…Inclusion criteria:Female patients with a request for permanenttubal sterilization.Exclusion criteria: not describedNo demographic data providedLaparoscopic sterilizationcompared to minilaparotomyIrrespective of the technique ofthe technique used forinterrupting tubal patence.(combined with culdoscopy alsoincluded)Essure sterilization.Anesthesia: NSAID)Outcomes (primary/ secondary) andassesment of outcomes:Operative mortality and majormorbidity (cardiac arrest, pulmonaryembolism, intestinal or vascularinjuries requiring additional surgery)Minor morbidity (intestinal or vascularinjuries not requiring additionalsurgery, post operative woundhaematoma or infectionnot requiring hospitalisation, urinarytract infection)Failure of surgical approach(laparoscopy converted intolaparotomyor extension of the mini-laparotomyincision), failure ofanaesthetic approach, duration ofoperation, hospital stay > 24hours, complaints (abdominal pain,analgesic use post-operatively,persistent abdominal pain at follow-up,other minor complaintsat follow-up)Duration of operation and length ofhospital stayWomen’s satisfaction (as questioned atfollow-up)Follow-up:Primary outcome:Bilateral tubal occlusion after Essuresterilization and complication rate.Secondary outcome:The use ofultrasound as diagnostic tool forverification of proper placement forthe 3-month follow-up.Follow-up: 3 monthsSix trials were included in the review.Minilaparotomy vs laparoscopy: There was no difference in majormorbidity between the 2 groups. Minor morbidity was significantlyless in the laparoscopy group (Peto OR 1.89; 95% CI 1.38, 2.59).Duration of operation was shorter with laparoscopy (WMD 5.34;95% CI 4.52, 6.16).Minilaparotomy vs culdoscopy: Major morbidity was higher forculdoscopy compared to minilaparotomy (Peto OR 0.14; 95% CI0.02, 0.98). Duration of operation was shorter with culdoscopy (WMD4.91; 95% CI 3.82, 6.01).Laparoscopy vs culdoscopy: In the one trial comparing the twointerventions there was no significant difference between the groupswith regard to major morbidity. Significantly more women sufferedfrom minor morbidities with culdoscopy (Peto OR 0.20; 95% CI- 0.05, 0.77).In 149 placement was attempted, in 6 patients device placement was notattempted (3 patients no access to the uterine cavity, 2 patients in whichthe tubal ostia could not be seen, and 1 vasovagal collapse)- Bilateral placement of the device was successful in(136/143) 95%(95% confidence interval [CI] 92%–99%). Seven attempts wereunsuccessful. The complication rate was 2% (n = 3), and all involveda perforation.Vaginal ultrasound was conclusive in 91.7% (95% CI 87%–96%) nb nocomparison with a standard was made.; two perforations were notrecognized on the ultrasound. In 11 patients (8.3%) extra diagnostictests were performed (X-ray or HSG). In two patients an incorrectposition due to tubal perforation was not recognized.Study groups clearly defined: (+)Selectionbias*: (+/-):three trialsreceived a scoreof ´ B´ for unclear methods ofrandomisation and of concealmentof allocation.Adequate assesment of exposure *:(+/-): in three trials allocationconcealment was judges unclearAdequate assesment of outcomes*:(+)Assesor of the effect adequatelyblinded*: (-)Sufficient length of follow-up*: (+)Selective loss tofollow-up*: (-)Identification ofconfounders andcorrection in analysis: (+)Financial support: -Study groups clearly defined: +Selectionbias*: nvtAdequate assesment of exposure *:+Adequate assesment of outcomes*:(+)Assesor of the effect adequatelyblinded*: -Sufficient length of follow-up*: +Selective loss tofollow-up*: -85