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. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

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
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
Interventions Hyaluronic acid and carboxymethylcellulose versus no treatment
SepraSpray applied to all sites of surgical injury with potential for adhesion formation
Outcomes Analysed in review
Adhesions at second‐look laparoscopy
  1. Number of women with adhesion at SLL

  2. Mean adhesion score at SLL

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
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