Ten Broek 2012.
Study characteristics | ||
Methods | Truly randomised trial (shuffled, sealed envelopes)
Time of randomisation: intraoperatively—just before barrier application Single‐blinded—women Power calculation: yes ITT: no Location: single centre—Netherlands Timing and duration: Sep 2002 to March 2004; 1 year 7 months |
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Participants | Females, 18 years of age and older, undergoing laparoscopic gynaecological surgery for benign gynaecological conditions (N = 16) Number undergoing second‐look laparoscopy: 15 (1 was excluded at first‐look laparoscopy) Timing second‐look laparoscopy: 4 to 8 weeks postoperative Blinding at second‐look laparoscopy: yes Exclusion criteria: pregnancy, lactating, malignancy, endometriosis stage IV, if complete adhesiolysis not possible |
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Interventions | Hyaluronic acid and carboxymethylcellulose versus no treatment SepraSpray applied to all sites of surgical injury with potential for adhesion formation |
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Outcomes | Analysed in review Adhesions at second‐look laparoscopy
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Notes | Prematurely ended for financial and organisational reasons Supported by Confluent Surgery Inc. Adhesions scored by Local Adhesion Barrier Scoring System, based on mAFS score |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sealed envelopes shuffled as randomisation. Unclear whether any other method of randomisation used |
Allocation concealment (selection bias) | Low risk | Allocations concealed in sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | women blinded; surgical team not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Initial surgeons blinded at time of initial outcome assessment; SLL surgeons blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No noted patient withdrawals |
Selective reporting (reporting bias) | Unclear risk | Data presented in full for all outcomes specified, however, no study protocol or trial registry identified for comparison. |
Other bias | Low risk |