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

Young 2005.

Study characteristics
Methods Truly randomised trial (central office–generated)
Time of randomisation: intraoperatively
Double‐blind. independent blinded video reviewer
Power calculation: yes, but study authors state not powered as pilot study
ITT: yes
Location: multi‐centre (6)—locations not stated
Timing and duration: not stated
Participants Females, 18 years of age and older, undergoing laparoscopic gynaecological surgery on at least 1 adnexa
Indication for surgery: adnexal pathology (e.g. adhesions, endometrioma, endometriosis, dermoid cyst, tubal occlusion)
Number randomly assigned: 28
Number undergoing second‐look laparoscopy: 27
Timing second‐look laparoscopy: 6 to 10 weeks postoperative
Blinding at SLL: yes
Exclusion criteria: not clearly stated
Interventions Carboxymethylcellulose and polyethylene oxide‐based gel versus no treatment
< 30 mL Oxiplex gel applied to areas where surgeon thought adhesions may occur
Outcomes Analysed in review
Adhesions at second‐look laparoscopy
  1. Number of women with improvement in adhesion score

  2. Number of women with worsening adhesion score


Other outcomes
Adhesions at second‐look laparoscopy
  1. Mean AFS score per adnexa at first‐look and SLL

  2. Change in adhesion score


Many results, then reported as per adnexa
Notes mAFS score
Funded by FzioMed Ltd
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No comment on method used for sequence generation
Allocation concealment (selection bias) Low risk Quote: "After a standard surgical treatment was completed and before closing, the investigator contacted a central office for subject group assignment"
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Initial surgeons not blinded to allocation. Not clearly stated whether women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "All surgeries were recorded and the videotapes were forwarded to a single masked reviewer to assess"
Incomplete outcome data (attrition bias)
All outcomes Low risk All 28 women randomly assigned were evaluated by second‐look laparoscopy. No issues identified
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 Data reported in terms of adnexae rather than individual women

CI – confidence interval

GnRHa ‐ gonadotropin‐releasing hormone agonist

IM ‐ intramuscular

IV ‐ intravenous

mAFS ‐ modified American Fertility Society adhesion score

PID – pelvic inflammatory disease

SD – standard deviation

SE – standard error

SEM ‐ standard error of the mean

SLL – second‐look laparoscopy