Thornton 1998.
Study characteristics | ||
Methods | Truly randomised trial (concealed envelope). Randomised as to whether left or right ovary treated
Time of randomisation: at initial procedure
Double‐blind Power calculation: no, feasibility study ITT: yes Location: multi‐centre (2)—USA Timing and duration: not stated |
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Participants | Females, 24 to 41 years of age, undergoing peritoneal cavity surgery via laparotomy Indication for surgery: not stated Number randomly assigned: 23 Timing second‐look laparoscopy: 4 to 12 weeks postoperative Blinding at second‐look laparoscopy: not stated Exclusion criteria: diabetes; haemochromatosis; hepatic, renal, autoimmune, lymphatic, haematological, or coagulation disorders; active pelvic infection; inflammation, or malignancy; frozen pelvis or hydrosalpinges; exposure to irrigation fluids other than RLS or saline solution; use of any other anti‐adhesion agents during surgery; use of topical haemostatic agents left in the body; use of catgut or non‐resorbable sutures on the ovaries or immediately adjacent structures; use of gasless laparoscopy, elective or accidental enterotomy; additional non‐O+G procedures performed; endometriosis stage IV at time of surgery; findings that prevented or precluded SLL |
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Interventions | 0.5% ferric hyaluronate gel versus Ringer's lactate | |
Outcomes | Adverse effects Other outcomes Adhesions at second‐look laparoscopy
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Notes | mAFS used No actual figures of standard error of the mean and SD given; thus standard deviations were imputed to include study in Analysis 1.4 Funded by Confluent Surgical Inc |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomisation schedule" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | One woman in the control group was excluded from efficacy analyses as she had a large number of adhesions at baseline, which all re‐formed. The explanation for this was to make the two study groups more comparable, however, the authors stated there were no statistically significant differences between the two groups at baseline, so there seems to be no clear reason for this exclusion. |
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 | High risk | Authors did not publish relevant numerical data (e.g. mean adhesion score, standard deviation) and only displayed their results in the form of a graph. |