Trew 2011.
Study characteristics | ||
Methods | Truly randomised trial (telephone‐generated)
Time of randomisation: 24 hours before surgery
Double‐blind. Independent blinded video reviewer Power calculation: yes ITT: yes Location: multi‐centre—25 centres in Europe Timing and duration: Sep 2003 to Aug 2005; 1 year 11 months |
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Participants | Females, 18 years of age and older, undergoing laparoscopic gynaecological surgery only Indication for surgery: myoma or endometriotic cysts Number randomly assigned: 498 Number undergoing second‐look laparoscopy: 330 Timing second‐look laparoscopy: 4 to 16 weeks postoperative Blinding at SLL: yes Exclusion criteria: endometriosis stage 3 to 4, AFS score moderate or severe, pregnancy, systemic corticosteroids, antineoplastic drugs or radiation, GnRHa, active pelvic or abdominal infection, known allergy to starch polymer, prior surgery for endometriotic cysts, > 4 myomas, largest myoma < 2 or > 8 cm in diameter, cancer, re‐formed adhesions not counted, drain, pedunculated cysts, use of glue or other anti‐adhesion agent |
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Interventions | Icodextrin 4% versus 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 Adhesions at second‐look laparoscopy
Other outcomes Adhesions at second‐look laparoscopy
Many subgroup analyses based on sites of adhesions |
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Notes | mAFS score. Looked only at de novo adhesions, not re‐formed Funded by Innovata Ltd, Vectura Group |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Treatment was randomised through a 24‐h central randomization telephone system" |
Allocation concealment (selection bias) | Low risk | Quote: "Double‐blinding was possible as both fluids are clear and odourless solutions with similar viscosities and were packaged identically" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Both women and initial operating surgeons blinded to allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The surgery was video recorded according to a detailed protocol to enable all assessments to be made through an independent and blinded review of video recordings...reviewers were blinded to the study treatment assignment, subject confidential information, and investigator site identifiers...first and second procedures were scored independently" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
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 Innovata Ltd, Vectura Group |