Larsson 1985.
Study characteristics | ||
Methods | Truly randomised trial (random number generated)
Time of randomisation: at end of surgery
Double‐blind Location: multi‐centre—5 centres in Sweden (Huddinge, Umea, Stockholm, Skovde, and Molndal) Timing and duration: not stated |
|
Participants | Infertile women undergoing open gynaecological microsurgery Condition: tubal or peritoneal adhesions, or both Surgery performed: adhesiolysis; tubal surgery (cases without adhesions excluded) Pre‐existing adhesions: all women Mean age: 31 years (range 21 to 39) Duration infertility: not stated Infertility work‐up: semen analysis, postcoital test, confirmation of ovulation (not specified), and laparoscopy; some also had hysterosalpingogram, sperm‐mucus penetration test, or both Number randomly assigned: 109 4 exclusions (lost to follow‐up) Number analysed: 105 Timing second‐look laparoscopy: 4 to 10 weeks postoperative Blinding at second‐look laparoscopy: not stated | |
Interventions | Dextran versus saline Route of administration: intraperitoneal Dosage/volume: dextran 250 mL; 0.9% saline 250 mL Prophylactic antibiotics: yes | |
Outcomes | Analysed in review Pregnancy rate
Full‐term pregnancy rate Miscarriage rate Ectopic rate Adhesions at SLL
Other outcomes Adhesions at SLL
Tubal patency Laboratory tests |
|
Notes | Adhesion scoring system used Own scoring system based on extent of adhesions (scored from 1 to 4) over tubes, fimbriae, and ovaries (range 4 to 24) 0 = none 1 = minimal 2 = mild (1 or 2 simple thin strands less than 1 cm in width) 3 = moderate (more than 2 adhesions of type 2 or at least 1 solid adhesion) 4 = severe (more than type 3) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "random selection sequence" |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Stated study was double‐blinded, but no clear details regarding blinding provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: was "double‐blinded," although no further information given. No mention of an independent reviewer or blinding during assessment |
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 | Low risk |