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 |
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| 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 |
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| 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 |
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| Outcomes | Analysed in review Adhesions at second‐look laparoscopy
Other outcomes Adhesions at SLL
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| 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 | |