Querleu 1989.
Study characteristics | ||
Methods | Truly randomised trial Double‐blinded (known by correspondence with study author) Power calculation: no Intention‐to‐treat analysis: yes Randomised trial: method not stated Time of randomisation: evening before surgery Factorial design Power calculation done Location: multi‐centre—5 centres in France (Clermond‐Ferrand, Montpellier, Paris, Roubaix, and Lyon) and 1 centre in the Netherlands (Nijmegen) Timing and duration: 1984 Sponsored by Laboratories Chanterau, France | |
Participants | Infertile women undergoing open gynaecological microsurgery Condition: distal tubal obstruction,pelvic adhesions, or both (active PID, endometriosis, proximal tubal obstruction cases excluded) Surgery performed: tubal surgery; adhesiolysis (19) Pre‐existing adhesions: analysis done according to pre‐existing adhesion status, but number not stated Age: not stated Duration infertility: not stated Infertility work‐up: not stated Number randomly assigned: 131 5 lost to follow‐up Number analysed: 126 Number undergoing second‐look laparoscopy: 88 Timing second‐look laparoscopy: 3 to 6 months postoperative Blinding at second‐look laparoscopy: not stated | |
Interventions | Auto‐cross‐linked hyaluronic acid versus no treatment
Time of application: end of the procedure
Second‐look laparoscopy performed: 60 to 90 days after primary procedure 1. Steroids versus no steroids Route of administration: systemic (IM) Dosage/volume: dexamethasone 2 mg day before surgery, 8 mg day of surgery and day after, 2 mg on following 5 days 2. Noxytioline versus no treatment Route of administration: intraperitoneal Dosage/volume: noxytioline (Noxyflex) 5 mg diluted in 250 mL normal saline instilled in the pelvis via a removable drain Other adjuvants: perioperative pelvic irrigation with heparinised (5000 IU/L) normal saline Prophylactic antibiotics: yes (doxycycline) |
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Outcomes | Analysed in review Pregnancy
Ectopic pregnancy rate Adhesions at second‐look laparoscopy
Other outcomes Adhesions at second‐look laparoscopy
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Notes | Adhesion scoring system used
Modified American Fertility Society endometriosis scoring system (range 0 to 84)
Adhesions graded as filmy, vascular, or dense
Power calculation envisaged participation of 10 centres, entering 32 women each Only 4 centres reached this number; 2 more centres entered fewer women Pregnancy rates also presented in a cumulative conception curve, using life‐table analysis for steroid and no‐treatment groups |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated that study was double‐blinded, but no further information regarding blinding provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women accounted for |
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 | Did not recruit enough women to power study as intended |