Richtlijn Sterilisatie van de vrouw - NVOG

ReferentieType studieKenmerken(studie/patiënten)Interventie (I)Uitkomstmaten enfollow-up duurResultatenBeoordelingkwaliteit studieDavis, 1990Prospectivecohort studycomparitiveInclusion criteria:Not described.Exclusion criteria:N=6 mini laparotomy.Demographics:Age mean years 34.1 filshie, 33.4 HulkaParity mean Filshie 2.9, 2.6 HulkaNo difference in PID or previous abdominalsurgery.Filshie Mark IV (N= 141) vsHulka-Clemens clips (N=142)-Complications of tubal sterilisation-Problems with tubal sterilisation-Postoperative pain measured by needof analgesia.Study groups clearly defined: (+)Selectionbias*: ( -) randomisationAdequate assesment of exposure *:(+)Adequate assesment of outcomes*:(+)Assesor of the effect adequatelyblinded*: (?) Not described.Sufficient length of follow-up*: (?)Selective loss tofollow-up*: (-)Identification ofconfounders andcorrection in analysis: (-), notdescribed.Financial support: (?) Notdescribed.Dominik, 2000 2multicenterrandomizedcontrolledtrialsN=2126Comparitive:1.Minilaparotomy (Hulkaclip vsFilshie clip)2.Laparoscopy (Hulkaclip vsFilshie clip)Inclusion criteria:- at least 21 years of age- legally able to consent to sterilization- normal physical and pelvic examinationresultsExclusion criteria:-Women that had undergone a pregnancytermination within the past 42 days- if they had a pre-existing clinicallyimportant abnormal condition suchas diabetes, renal or cardiac disease.- Women who were already pregnant- Women undergoing surgery other thanroutine curettage or IUD removal concurrentwith sterilization.- women who required sterilization forreasons other than voluntarily limitingthe size of their family.Minilaparotomy N=878Laparoscopy N=1248Filshie clips N=1066Hulka clips N=1060- The effectiveness outcome of interestwas pregnancy.- Surgery injuries and safetyFollow-up: 12 months.Although follow-up was high withrespect to short-term safety outcomes,long -term follow-up rate wasdisappointing.Study groups clearly defined: (+)Selectionbias*: (-), blindrandomisationAdequate assesment of exposure *:(+) randomisation for occlussiondevices.Adequate assesment of outcomes*:(+)Assesor of the effect adequatelyblinded*: (+) for occlusion devices.Sufficient length of follow-up*:(+/?/-)Selective loss tofollow-up*: (+) Less educated78