Richtlijn Sterilisatie van de vrouw - NVOG

ReferenceType studyCharacteristicsIntervention (I)Outcomemeasured andfollow upResultsQualityassessmentLarsen,1983Combination ofdifferentstudydesigns:cohortstudyincluding aRCT onlocal tubalanestheticspartlycomparativeN = 192wereplanned,189 wereperformedInclusion criteria:sterilizations performed during the intervalphase or in connection with termination ofpregnancy (four postpartum sterilisations,44 in connection with termination ofpregnancy 141 were sterilized during theinterval phase and of these 139 had afractionated curettage simultaneously?)Exclusion criteria:Age (mean/ average/ 95% CI)BMI (mean/ average/ 95% CI)Other relevant demographics…Laparoscopicsterilizationwith thefalope ring.generalanesthesiaand a singlepuncturetechnic wasused.100 patientswererandomisedto a lidocainand a nonlidocainGroup: 2.5ml oflidocaine 1%were drippedonto thatpart of thetube whichwas ligatedby theFalope-ring.Outcomes:peroperativecomplications and thefrequency ofcomplicationsassociated withsterilizationsperformed during theinterval phase or inconnection withterminationof pregnancy.The possible analgeticeffectof application oflidocaine to the tubehas been investigatedin a randomized trial.(n = 100)The effectiveness ofthe method and theoccurrence of latecomplicationshave been evaluated infollow-upinvestigations.(pregnancies)Follow-up: Of 100consecutively sterilizedwomen, 91participated ina clinical investigation,on average 16 months(11-22 months) afterthe operation.Bleeding patterns andthe occurrenceof low abdominal painwere recorded and apelvic exam was made.3 planned procedures were abbandoned because of failure to visualize the tubesbecause of pelvicadhesions (2 cases) or equipment malfunction (1 case).In all, the frequency of complications was 17.5% (95% confidence limits 12-24'70).No significant difference between complications in sterilizations undertaken inconnection with abortion (18.2%) and sterilizationsperformed during the interval phase (17.0%).Postoperative pain during the First 24 hours : 18% )non/lidocaine vs 24% inlidocain group. NSThe occurrence of change in bleeding pattern in women who used OC prior tothe sterilization was higher than among those who did not, but the difference isnot statistically significant.Of 60 women without previously recorded pain, 24 (40%, ,28 - 53%) did havepain after the sterilization and the number of women with pain increasedsignificantly (p < 0.05). The increase, however, was only significant among thosewomen who previously used OC, not among those who did not (pp>0.5).1 Pregnancy- 172 women in 3 months. 0.6% (95% confidence limits 0.01 -3.2%).Four regrets.Study groups clearly defined: +Selectionbias*: ? randomisation for lidocain notexplained.Adequate assesment of exposure *: (+)Adequate assesment of outcomes*: forcomplications yes. For pain and othercomplaints± no.Assesor of the effect adequately blinded*: ?Sufficient length of follow-up*: ~forinteroperative and shortly postoperativecomplications.Selective loss tofollow-up*: = Incongruency in follow/upassesments.Identification ofconfounders andcorrection in analysis: -Financial support: not reported169 participated in aquestionnaireinvestigationconcerning incidenceof climacteric108