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

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)
Outcomes Analysed in review
Pregnancy
  1. Method of diagnosis: not specified

  2. Duration follow‐up: 36 months


Ectopic pregnancy rate
Adhesions at second‐look laparoscopy
  1. Improvement; deterioration or no change

  2. Change in score


Other outcomes
Adhesions at second‐look laparoscopy
  1. Change in score according to initial score

  2. Change in score according to grade of adhesions

  3. Change in score in subgroup of pure adhesiolysis

  4. Grade of adhesions

  5. Per cent of ovarian surface free of adhesions

  6. Fimbrial status

  7. Mobility of the tube

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
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