Liu 2015.
Study characteristics | ||
Methods | Unit of randomisation: women Method of randomisation: central web‐based programme Time of randomisation: after completion of surgery Blinding: women blinded. Surgeons analysing recordings blinded. Multi‐centre trial |
|
Participants | Women aged 18 to 45 years, undergoing laparoscopic surgery for removal of adhesions, myomas, ovarian cysts, or endometriotic cysts, with negative pregnancy tests Intention‐to‐treat: yes Exclusion criteria: acute or severe infection, autoimmune disease, abnormal liver or renal function (ALT or creatinine > 50% upper normal limit), abnormal cardiovascular function (grade III and above), abnormal blood coagulation, medical history of peripheral vascular disease, alcohol or drug abuse, mental illness, known or suspected intolerance to hyaluronan or derivatives, use of anti‐inflammatory drugs, use of anticoagulant, fibrin glue, thrombogenic agents, anti‐adhesion agents used during procedure, concurrent peritoneal grafts or tubal implantation. N = 216 108 randomised to intervention and 108 to control Dropouts: 1 woman in intervention group was incorrectly randomised and did not receive the allocated intervention. 19 women (14 control and 5 intervention) did not show up for second‐look laparoscopy. Age: mean age 29.53 in intervention group and 29.95 in control group Baseline characteristics: in the intervention group, severity of pre‐existing adhesions was significantly greater than in the control group. No other significant differences Indication for surgery: variety of indications Pre‐existing adhesions: present in the majority of women Aetiology of pre‐existing adhesions: mostly previous surgery, or chronic infections, or both Microsurgery: no Additional surgical procedures: various extra procedures performed on a number of women Location: 6 centres in China Timing: June 2011 to April 2013 Study duration: 12 weeks |
|
Interventions | Cross‐linked hyaluronic acid versus saline Other adjuvants used: none stated Second look laparoscopy:
|
|
Outcomes | Adhesions at second‐look laparoscopy:
Adverse events |
|
Notes | Study supported by grants from BioRegen Biomedical (Changzhou) Co Ltd Video recording taken at initial surgery and second‐look laparoscopy Power calculation: stated 108 women needed in each arm Clinicaltrials.gov register number: NCT02166554 |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were assigned at random to either the NCH gel or control group in a 1:1 ratio through a central web‐based program." |
Allocation concealment (selection bias) | Low risk | women were only assigned to control or treatment group after the first‐look laparoscopy. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | women blinded, operators not blinded due to difference in viscosity of intervention versus control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All videos were provided to 2 qualified reviewers for blinded assessment. To ensure minimal interobserver variability, adhesion scoring in the blinded reviewer assessments was compared, and any discrepancies were settled by the principal investigator." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 14 lost to follow‐up past randomisation to control; 5 lost to follow‐up past randomisation to treatment; 1 patient incorrectly randomised |
Selective reporting (reporting bias) | Low risk | All outcomes stated in trial registry are reported ‐ NCT02166554 |
Other bias | Low risk | Severity of pre‐existing adhesions significantly greater in NCH gel compared to control group. |