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

Jansen 1985.

Study characteristics
Methods Truly randomised (random number generated)
Time of randomisation: not stated
Factorial design
Power calculation: yes
Location: Sydney, Australia
Timing and duration: Feb 1982 to Nov 1983
Participants Females older than 18 years of age scheduled for gynaecological laparoscopic surgery for pelvic pain and infertility
Condition: pelvic adhesions, endometriosis
Surgery performed: adhesiolysis and tubal, adnexal surgery
Mean age: 31 years for study group (range 21 to 40); 32 years for control group (range 18 to 50)
Number eligible: 62
Number undergoing second‐look laparoscopy: 53
Infertile women undergoing open gynaecological microsurgery
Condition: peritubal adhesions (76), endometriosis (27), midtubal occlusion (61)
Surgery performed: salpingolysis on its own (92) or with tubal reanastomosis (20); endometriosis surgery (11); tubal reanastomosis (41)
Pre‐existing adhesions: 119 women
Mean age: 30 years (range 21 to 39)
Duration infertility: not stated
Infertility work‐up: not stated
Number eligible: 170
Number randomly assigned: 168
Number undergoing SLL: 164
Interventions 1. Dextran versus Hartmann's solution
Route of administration: intraperitoneal
Dosage/volume: dextran 100‐200 mL; Hartmann's 100 mL or more
2. Steroids versus no treatment
Route of administration: intraperitoneal + systemic (IV and oral) if pre‐existing adhesions or endometriosis
Dosage/volume: intraperitoneal: 500 mg hydrocortisone in 100 mL to 200 mL of dextran or Hartmann's; systemic: 8 mg of IV dexamethasone at time of surgery and 30 mg oral prednisolone daily until second‐look laparoscopy (SLL)
Other adjuvants: perioperative pelvic irrigation with heparinised (5000 IU/L) Ringer's
Prophylactic antibiotics: yes
Timing SLL: 12 to 21 days
Blinding at SLL: yes
Outcomes Analysed in review
Pregnancy
Method of diagnosis: not stated
Duration follow‐up: 1 to 18 months
Live birth
Miscarriage rate
Ectopic rate
Adhesions at second‐look laparoscopy
  1. Present; absent

  2. Improvement; deterioration


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

Notes Adhesion scoring system used
Modified American Fertility Society endometriosis scoring system (range 0 to 27)
Results expressed as medians with 95% confidence limits
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization sequences were generated by a random number‐generation program, and assignment of adjuncts was carried out strictly in the pre‐determined sequence. Two separate randomizations were carried out independently"—1 for dextran or no dextran, and 1 for steroids or no steroids
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "Although completely effective blinding in the allocation of the adjuncts was not practicable (owing to the viscous nature of the dextran solution and the need to administer systemic corticosteroids to some women), information on allocation and use of adjuncts was not recorded in the operation notes, and was not readily available at the time of postoperative laparoscopy".
Inital surgeons not blinded to allocation and unclear whether women were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Qualification of adhesions was carried out from operation diagrams at a later date, without knowledge of the patient's identity or the use of an adjunct"
Incomplete outcome data (attrition bias)
All outcomes Low risk All women accounted for, 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 Low risk None detected