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

Lundorff 2005.

Study characteristics
Methods Truly randomised trial
Time of randomisation: during initial surgery
Double‐blind: videoed and blinded reviewer scored adhesions
Power calculation: no
ITT: no
Location: multi‐centre (4)—Europe
Timing and duration: not stated
Participants Females, 18 to 46 years of age and older, undergoing laparoscopic peritoneal cavity surgery (N = 49)
Surgery performed: laparoscopy and adhesiolysis
Pre‐existing adhesions: not all women
Number randomly assigned: 14
Timing second‐look laparoscopy: 6 to 10 weeks postoperative
Blinding at second‐look laparoscopy: yes
Exclusion criteria: participant had diabetes, hepatic or renal disorders, pelvic or abdominal infection, history of malignancy within 5 years of study; had received systemic corticosteroids within 30 days of surgery; pregnant; converted to open surgery; exposure to irrigation fluids other than RLS or saline solution; use of any other anti‐adhesion agents during surgery, use of topical haemostatic agents left in the body; elective or accidental enterotomy; no evidence of adnexal disease or endometriosis at first‐look laparoscopy
Interventions Carboxymethylcellulose and polyethylene oxide‐based gel versus no treatment
Outcomes Safety outcomes
Other outcomes
Adhesions at second‐look laparoscopy
  1. Change in adhesion score: numerical and categorical

  2. Shift analysis


Subanalyses based on stage of endometriosis
Notes mAFS used
Scored per adnexa, not per participant; thus the results could not be included in the meta‐analysis, although appears to have used an external control
Funded by FzioMed Inc
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisation schedule" was used
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The entire procedure was recorded on videotape...blinded reviews of the videotapes were performed to quantify adhesion scores"
Incomplete outcome data (attrition bias)
All outcomes Low risk All 86 adnexae that were enrolled were analysed
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 in part by FzioMed Inc