Skip to main content
. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

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
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
Interventions 0.5% ferric hyaluronate gel versus Ringer's lactate
Outcomes Adverse effects
Other outcomes
Adhesions at second‐look laparoscopy
  1. Presence of adhesions

  2. Number of adhesions

  3. Extent of adhesions

  4. Severity of adhesions

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
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.