| Study characteristics |
| Methods |
True randomisation (randomisation list)
Pilot study; therefore, no power calculation was performed
Multi‐centre: 5 centres in USA
Blinding: assessor blind |
| Participants |
Adult women, older than 18 years of age, scheduled for gynaecological laparoscopic surgery for pelvic pain and infertility
Condition: pelvic adhesions, endometriosis
Surgery performed: adhesiolysis and tubal, adnexal surgery
Mean age: 31 years for study group (range 21 to 40) and 32 years for control group (range 18 to 50)
Number eligible: 62
Number undergoing second‐look laparoscopy: 53 |
| Interventions |
Icodextrin 4% versus Ringer's lactate
Timing second‐look laparoscopy: 6 to 12 months |
| Outcomes |
Analysed in review
Adhesions present, improvement or deterioration in adhesion scores at second‐look laparoscopy
Duration follow‐up: 6 to 12 months
Other outcomes: change in adhesion score at second‐look laparoscopy
No data on pregnancy rates |
| Notes |
Adhesion scoring system used
Modified American Fertility Society endometriosis scoring system |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Each patient was assigned the next available study number which was pre‐allocated to treatment according to a randomization list" |
| Allocation concealment (selection bias) |
Low risk |
Sealed treatment codes provided to centres by the supplier of the investigational product |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Initial surgeons not blinded. Not clearly stated whether women were blinded to treatment allocation. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Third party–blinded videotape review of adhesions at initial and second surgeries |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
4 withdrawn because of major protocol violation after initial surgery. 1 woman did not return for second surgery. 4 further protocol violators withdrawn (1 because study device was not being used correctly, 3 because of adhesions at more than 50% of sites. 53 of 62 included in per‐protocol analysis) |
| 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 |
|
