Johns 2001.
Study characteristics | ||
Methods | Truly randomised, third party–blinded study (randomisation schedule) Multi‐centre: 16 centres in the USA and Europe Power calculation: no | |
Participants | Women aged 18 to 46 years, undergoing peritoneal cavity surgery by laparotomy Intention‐to‐treat: no Exclusion criteria: diabetes, haemochromatosis, hepatic disorders, renal disorders, lymphatic disorders, haematological disorders, autoimmune disorders, coagulation disorders, patients with pelvic or abdominal infection, patients receiveing cancer therapy, postoperative hydrotubation, anticoagulants, fibrin glue or other thrombogenic agents at initial surgery. N = 265 131 randomised to gel and 134 to Ringer's lactate Dropouts: 16 patients did not return for SLL. Age: mean age not stated Baseline characteristics: No significant differences in severity or extent of adhesions at baseline Indication for surgery: variety of indications Pre‐existing adhesions: present in the majority of women Aetiology of pre‐existing adhesions: not clearly stated Microsurgery: no Additional surgical procedures: not clearly stated Timing: not clearly stated |
|
Interventions | 0.5% ferric hyaluronate gel versus Ringer's lactate Volume: 300 mL Ringer's lactate or Intergel instilled at the end of the procedure Antibiotics: no Second‐look laparoscopy: 6 to 12 weeks after primary procedure | |
Outcomes | Analysed in review
Other outcomes
Pregnancy rates: no |
|
Notes | Adhesion scoring system used
Funded by Lifecore Biomedical Inc |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "At the time of initial surgical procedure, patients were assigned the next available study number corresponding to study device or control solution as determined by the randomization schedule" |
Allocation concealment (selection bias) | Low risk | Study device or control solution was maintained in a sealed carton until decision to enrol the participant was made |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Initial surgical team not blinded to allocation. Not clearly stated whether women blinded to allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded independent review of adhesion data as a quality assurance check |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 281 randomly assigned women receiving treatment—a total of 265 completed the study. Quote: "Of the 16 patient[s] who did not return for laparoscopy, 9 women discontinued for reasons unrelated to treatment. Although treatment‐related discontinuation could not be ruled out in the other seven women, a similar number were present in the treatment (N = 4) and control (N = 3) groups" |
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 |