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
Other outcomes Blood transfusion requirements Wound healing |
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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 |
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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 |