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

Jansen 1988.

Study characteristics
Methods Truly randomised trial (random numbers generated)
Time of randomisation: not stated
Power calculation done
Location: Sydney, Australia
Timing and duration: Nov 1983 to Oct 1984
Participants Infertile women undergoing open gynaecological microsurgery
Condition: pelvic adhesions; endometriosis; tubal disease; uterine abnormalities
Surgery performed: adhesiolysis or treatment for endometriosis (52); tubal anastomosis or uterine surgery (40)
Pre‐existing adhesions: 63 women
Mean age: 28 years (range 21 to 42)
Duration infertility: not stated
Infertility work‐up: not stated
Number eligible: 102
Number undergoing second‐look laparoscopy: 92
Timing second‐look laparoscopy: 12 days postoperative
Blinding at second‐look laparoscopy: yes
Interventions Heparin containing Ringer's lactate versus Ringer's lactate
Route of administration: intraperitoneal preoperative pelvic irrigation
Dosage/volume: Ringer's solution containing 5000 IU heparin/L
Other adjuvants: 52 women with pre‐existing adhesions or endometriosis received systemic steroids intraoperatively and postoperatively. The first 46 women in the study received intraperitoneal steroids
Prophylactic antibiotics: yes
Outcomes Analysed in review
Adhesions at second‐look laparoscopy
  1. Improvement; no change; deterioration

  2. Change in score


Other outcomes
Blood transfusion requirements
Wound healing
Notes Adhesion scoring system used
Modified American Fertility Society endometriosis scoring system (range 0 to 27)
Data for adhesions at SLL (improvement; no change; deterioration) derived from scatter plot
Some study information supplied in correspondence from study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Strictly in a pre‐determined random sequence"
Allocation concealment (selection bias) Unclear risk Insufficient information available to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "Although completely effective blinding in heparin use was not practicable, owing to its obvious anticoagulant effect during the operation, information on its allocation was not recorded in the operation notes and was not available at the time of postoperative laparoscopy".
Initial surgeons not completely blinded to allocation and unclear whether women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Improvement scores were derived later, without knowledge of the identity of the patient, or the use of heparin"
Incomplete outcome data (attrition bias)
All outcomes Low risk No missing outcome data
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 Unclear risk The practice of adding hydrocortisone sodium succinate to the irrigation solution was stopped after 46 women had received it, because of a possible detrimental effect reported in an earlier study