Diamond 2003.
Study characteristics | ||
Methods | Randomised trial, although method of randomisation not stated
Time of randomisation: during surgery
Double‐blind. independent blinded reviewer scored videos of surgery, in addition to the surgeon who performed the procedure Power calculation: no, pilot study Location: multi‐centre (4)—USA Timing and duration: not stated |
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Participants | Females 18 years of age and older undergoing laparoscopic gynaecological surgery only (N = 34) Indication for surgery: pelvic pain, infertility, pelvic mass, uterine fibroids, endometriosis Surgery performed: laparoscopy Pre‐existing adhesions: not all women Number analysed: 32 (videotape not made in 1 case, 1 did not undergo SLL because of a reaction that was subsequently attributed to existing rheumatoid arthritis) Timing second‐look laparoscopy: 2 to 10 weeks postoperative Blinding at second‐look laparoscopy: yes, independent blinded reviewer used Exclusion criteria: pregnant, lactating, had previously undergone salpingectomy, oophorectomy, or hysterectomy, had a known cancer, active PID, received hormonal therapy within 1 month of initial surgery |
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Interventions | N,O‐carboxymethyl chitosan versus instillant of Ringer's lactate > 100 mL every 30 minutes, no limit on amount used for irrigation. 1000 mL instilled at end |
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Outcomes | Analysed in review Adverse effects Other outcomes Adhesions at second‐look laparoscopy
Duration surgery |
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Notes | mAFS score used, data presented in a way that did not allow us to include results regarding adhesions at SLL Funded by Chitogenetics |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States: was randomised "just before closure" but method not described |
Allocation concealment (selection bias) | Unclear risk | no comments on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not clearly stated whether women or initial surgeons were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Each surgical procedure was videotaped in its entirety. After editing to remove application of the test or study agent, the video of each procedure was reviewed by an evaluator who was blinded to group assignment. The reviewer applied the same scoring system as the surgeons" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All but 1 woman in the NOCC group underwent SLL; this patient developed a reaction that was subsequently attributed to her pre‐existing rheumatoid arthritis. A videotape was not made for one participant in the control group and thus, was not available for blinded review" |
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 | Funded by Chitogenetics. Significant baseline differences between control and treatment groups—co‐variate analysis used |