Buttram 1983.
| Study characteristics | ||
| Methods | Truly randomised trial (method not stated) Time of randomisation: not stated Double‐blind Location: multi‐centre—9 centres in the USA (Duke, Yale, Baylor, USC, Vanderbilt, Washington, Indiana, Navy, and Masachussets) Timing and duration: not stated | |
| Participants | Infertile women undergoing open gynaecological surgery (macrosurgery 53, loupe magnification 32, microsurgery 17) Condition: pelvic inflammatory disease with distal tubal disease (42), endometriosis (14), pelvic adhesions (46) Surgery performed: adhesiolysis, tubal surgery Pre‐existing adhesions: all women Age: 18 to 35 years (mean not stated) Duration infertility: not stated Infertility work‐up: semen analysis, postcoital test, and confirmation of ovulation (method not stated). Any abnormality was corrected before surgery Number randomly assigned: ? (no exclusions stated) Number undergoing treatment: 102 Number undergoing second‐look laparoscopy: 91 (11 conceived before laparoscopy) Timing second‐look laparoscopy: 8 to 12 weeks postoperative Blinding at second‐look laparoscopy: not explicitly stated Females 18 years of age and older undergoing laparotomy for gynaecological surgery Exclusion criteria: pregnancy, cancer, PID Number of women randomly assigned: 102 | |
| Interventions | Dextran versus normal saline Route of administration: intraperitoneal Dosage/volume: dextran 250 mL; saline 250 mL Prophylactic antibiotics: yes | |
| Outcomes | Analysed in review Pregnancy rate
Adhesions at second‐look laparoscopy
Other outcomes` Adhesions at second‐look laparoscopy
Appearance of tube Tubal patency rate Postoperative infection rate |
|
| Notes | Adhesion scoring system used Hulka system based on extent of adhesions (scored from 1 to 4) over fimbriae and ovaries (range 0 to 16) 1 = whole organ seen 2 = > 50% seen 3 = < 50% seen 4 = totally obscured | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to permit judgement. "Patients were randomly assigned to either treatment" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to permit judgement. "Blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement. "Blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Exclusion criteria for randomisation; number of women randomly assigned not stated. All women who underwent treatment were 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 | No others |