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. 2020 Jul 17;2020(7):CD001298. doi: 10.1002/14651858.CD001298.pub5

Tchartchian 2014.

Study characteristics
Methods Unit of randomisation: women
Method of randomisation: computer‐generated allocation schedule randomising 2:1 externally prepared and stored in envelopes
Time of randomisation: not clearly stated but apparently intraoperatively
Blinding: women blinded; surgeons analysing recordings blinded.
Participants Women, aged 18 and older, with child‐bearing potential, undergoing laparoscopic myomectomy due to at least one myoma
Exclusion criteria: pregnancy, lactation, previous open or closed myomectomy for myomas, active endometriosis, infection, inflammatory of bowel disease, pelvic inflammatory disease, frozen pelvis, hydrosalpinges
N = 15
9 randomised to intervention and 6 to control
Dropouts: 2 women (one from each group) withdrew consent prior to second‐look laparoscopy
Age: mean age 35.8 in intervention group, and 44.3 in control group
Baseline characteristics: the control group was significantly older (P = 0.002), had significantly higher gravidity (P = 0.021), and significantly larger number of previous vaginal deliveries (P = 0.038) than the control group.
Indication for surgery: myomectomy for removal of at least one myoma
Pre‐existing adhesions: 66.7% of the intervention group and 50.0% of the control group had pre‐existing adhesions (P = 0.662)
Aetiology of pre‐existing adhesions: not clearly stated
Microsurgery: surgery was based on the basic principles of microsurgery
Additional surgical procedures: not clearly stated
Location: Oldenburg, Germany
Timing: November 2008 to May 2009
Interventions Polyethylene glycol ester amine versus no treatment
Other adjuvants used: none stated
Second‐look laparoscopy:
  1. Timing: 8 to 12 weeks after initial surgery

  2. Surgeon blinded: not stated

  3. Adhesiolysis: performed in women still wanting to conceive

Outcomes Adhesions at second‐look laparoscopy:
  1. Adhesion score (incidence, severity, and extent)

  2. Number of sites with adhesions

  3. Area of sites adherent to the uterus


Adverse events
Notes Funding provided by Covidien
Video recording performed both at initial surgery and second look laparoscopy
Power calculation not performed
Clinicaltrials.gov register number: NCT00891657
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Subjects were randomly assigned in a 2:1 ratio to the SprayShield Adhesion Barrier group or the control group according to a computer‐generated allocation schedule."
Allocation concealment (selection bias) Low risk Quote: "Patient blinding was performed intraoperatively through a third person with externally prepared randomisation using envelopes."
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk women blinded, operating surgeons not blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "To blind the reviewer to subject and treatment, all videos were assigned a unique, blind code."
"The videos were edited to remove the phase of the SprayShield Adhesion barrier application from treated subjects."
"The videos were sent to an independent gynaecological surgeon to obtain standardised, unbiased evaluation of adhesion formation."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 2 out of 15 women lost to follow‐up
Selective reporting (reporting bias) Low risk All outcomes stated in trial registry reported ‐ NCT00891657
Other bias High risk Multiple statistically significant differences between the two groups at baseline
Quote: "Due to the low number of patients' efficacy, data are not final regarding the performance of SprayShield Adhesion Barrier"