Coddington 2009.
| Study characteristics | ||
| Methods | Truly randomised trial: no comment regarding method of randomisation
Time of randomisation: no comment about timing of randomisation
Blinding: single‐blind trial Power calculation: no power calculation ITT: no Location: sIngle centre. Location not stated Timing and duration: not stated |
|
| Participants | Women of reproductive age undergoing surgery for symptomatic uterine leiomyomata 20 women randomly assigned 2 women excluded from analysis because of severe pelvic adhesive disease and no myoma requiring treatment Second‐look laparoscopy 2 to 10 weeks after initial surgery Blinding at second‐look laparoscopy: yes |
|
| Interventions | 3 months' preoperative treatment with GnRHa therapy (Lupron 3.75 mg monthly depot injection) or placebo (saline) Surgery within 4 weeks of last injection |
|
| Outcomes | Second‐look adhesion area (cm²) defined as surface of uterine visceral peritoneum covered with adhesions Ratio of adhesion area (cm²) to total myometrial, incision length in cm (total length of all incisions made through uterine visceral peritoneum) |
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| Notes | Received funding from TAP Pharmaceuticals | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to allow judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to allow judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to allow judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The same senior surgeon performed all adhesion scoring and was blinded to the treatment group of the women. All procedures were videotaped and measurements confirmed by an external reviewer" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No outcome data missing |
| 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 | |