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 |
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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 |
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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
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 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 |