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 |
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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 |
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Interventions | Carboxymethylcellulose and polyethylene oxide‐based gel versus no treatment | |
Outcomes | Safety outcomes Other outcomes Adhesions at second‐look laparoscopy
Subanalyses based on stage of endometriosis |
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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 |
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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 |