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 |
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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 |
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Interventions | Carboxymethylcellulose and polyethylene oxide‐based gel versus no treatment < 30 mL Oxiplex gel applied to areas where surgeon thought adhesions may occur |
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Outcomes | Analysed in review Adhesions at second‐look laparoscopy
Other outcomes Adhesions at second‐look laparoscopy
Many results, then reported as per adnexa |
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Notes | mAFS score Funded by FzioMed Ltd |
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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