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

Mais 2006.

Study characteristics
Methods Truly randomised trial (computer‐generated sequence, sealed envelopes)
Time of randomisation: intraoperatively
Double‐blind: reviewer was blinded
Power calculation: no
ITT: yes
Location: Italy, multi‐centre—4 (Cagliari, Florence, Padova, Turin)
Timing and duration: March 2002 to March 2004; 2 years
Participants Females with both tubes and ovaries undergoing laparoscopic myomectomy for 1 to 3 subserous, intramural myomas
Indication for surgery: pelvic pain and infertility (93), infertility investigation (214), endometriosis (243)
Age: 22 to 42 years
Number randomly assigned: 52
Number undergoing second‐look laparoscopy: 43 (9 lost to follow‐up)
Timing second‐look laparoscopy: 12 to 14 weeks postoperative
Blinding at second‐look laparoscopy: yes
Exclusion criteria: postmenopausal, pregnancy, largest myoma < 20 mm or > 50 mm; history of diabetes, hepatic disorders, renal disorders, severe cardiopathies, malignancies; previous administration of anti‐adhesion agents; presence of pelvic, abdominal infection; oral steroids, immunosuppressives, cytostatic treatment, coagulation disorder, insufficient intraoperative haemostasis
Interventions Auto‐cross‐linked hyaluronic acid versus no treatment
Ringer's lactated saline used as irrigant, then Hyalobarrier applied at end of operation in those randomly assigned to the treatment group, for all uterine incisions and suture material
Outcomes Analysed in review
Adhesions at second‐look laparoscopy
  1. Mean adhesion score at first‐look and second‐look laparoscopy

  2. Number of women with adhesions at SLL


Other outcomes
Adhesions at SLL
  1. Subanalyses of uterine adhesions only

Notes Operative Laparoscopy Study Group scoring system used
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Computer generated 1:1 random allocation sequence"
Allocation concealment (selection bias) Low risk Quote: "Concealed in numbered sealed envelopes until interventions assigned"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Initial surgeons not blinded. Not clearly stated whether women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Initial surgeons blinded at time of assessment of adhesions. Second‐look laparoscopy surgeons blinded to allocation.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "Of 52 patients, five in Hyalobarrier gel group and four in control group...declined to undergo second‐look laparoscopy...for personal reasons"
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