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

Trew 2017.

Study characteristics
Methods Unit of randomisation: women
Method of randomisation: via telephone to an interactive voice response system or via electronic case report form centralised at the University of Glasgow
Time of randomisation: following primary surgery, prior to closure of abdomen
Blinding: women blinded; surgeons analysing recordings blinded; operating surgeons not blinded
Multi‐centre study
Participants Premenopausal women aged 18 to 46 years, undergoing gynaecological laparoscopic surgery with a planned, clinically indicated second‐look laparoscopy 4 to 12 weeks
N = 66
35 randomised to intervention and 31 to control
Dropouts: 3 women (1 from the control group and 2 from the intervention group) withdrew consent prior to second look laparoscopy
Age: mean age 33.6
Baseline characteristics: in the intervention group, more women were smokers and fewer had a history of treatment for uterine fibroids. Otherwise, no significant differences stated
Indication for surgery: not clearly stated, but all women wished to maintain fertility
Pre‐existing adhesions: 87.9% of the intervention group and 60.0% of the control group had pre‐existing adhesions
Aetiology of pre‐existing adhesions: not clearly stated
Microsurgery: surgery was performed using the basic tenets of microsurgery
Additional surgical procedures: not clearly stated
Location: three centres in Germany and one in Greece
Timing: November 2013 to June 2014
Interventions Dextran aldehyde and polyethylene glycol amine versus no treatment
Other adjuvants used: none stated
Second look laparoscopy:
  1. Timing: 4 to 12 weeks after initial surgery

  2. Surgeon blinded: not clearly stated

  3. Adhesiolysis: not clearly stated

Outcomes Adhesions at second look laparoscopy:
  1. Adhesion score (severity and extent)

  2. Adhesion incidence


Adverse events
Notes Funding provided by Actamax Surgical Materials LLC
Video recording performed both at initial surgery and second‐look laparoscopy
Power calculation not performed for efficacy analysis
Clinicaltrials.gov register number: NCT02260115
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomization was stratified by surgeon and by surgical subgroup. Randomization was conducted in permuted blocks of two within each stratum to ensure approximate treatment balance within each surgeon and subgroup at the end of the study"
Allocation concealment (selection bias) Low risk Quote: "Allocations were obtained by telephone to an interactive voice response system or via the electronic case report form managed by the Robertson Centre for Biostatistics, University of Glasgow, so that allocations were concealed from study sites until the time of randiomization."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk women blinded, personnel not blinded
operating surgeons not blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Following the SLL, copies of paired videos for the primary surgery (with application section removed) and SLL were provided to the blinded evaluator assigned to assess adhesions."
"The independent blinded reviewer assessing the postoperative adhesions on SLL videotape whilst being blind to the randomisation allocation of the patient would believe, if they observed any residual material to be present, that a subject had received hydrogel during their primary surgery"
Incomplete outcome data (attrition bias)
All outcomes Low risk 12 of 78 women were not randomised, evaluated in the initial usage group. 3/66 randomised women lost to follow‐up
Selective reporting (reporting bias) Low risk All outcomes stated in trial registry were reported ‐ NCT02260115
Other bias Low risk "Despite randomisation, statistically significantly more subjects in the treatment group had baseline adhesions"