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. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

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
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
Interventions Icodextrin 4% versus Ringer's lactate
> 100 mL every 30 minutes, no limit on amount used for irrigation. 1000 mL instilled at end
Outcomes Analysed in review
Adhesions at second‐look laparoscopy
  1. Mean adhesion score


Other outcomes
Adhesions at second‐look laparoscopy
  1. Number of adhesions

  2. 1 or more de novo adhesions at SLL

  3. Number of de novo adhesions at SLL

  4. Mean AFS score reduction

  5. Number of women free of de novo adhesions


Many subgroup analyses based on sites of adhesions
Notes mAFS score. Looked only at de novo adhesions, not re‐formed
Funded by Innovata Ltd, Vectura Group
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