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

Hellebrekers 2009.

Study characteristics
Methods Truly randomised trial (computer‐generated schema)
Time of randomisation: at scheduling of surgery
Blinding: single‐blind
Power calculation: no
ITT: no
Location: sIngle centre—Leiden University Medical Centre
Timing and duration: not stated
Participants women 18 years of age or older who were candidates for open abdominal myomectomy with tubes and ovaries present bilaterally. All women were menstruating regularly, none had received hormonal treatment for at least 2 months before surgery. Good general health with no significant systemic conditions (N = 26)
Indication for surgery: clinical indications for myomectomy not stated
Number undergoing second‐look laparoscopy: 25
Timing second‐look laparoscopy: 8th postoperative day
Exclusion criteria: pregnancy, haematological disorder, or coagulopathy, cancer therapy, unavailable for study duration, ongoing pelvic infection, participation in other clinical investigations, diabetes mellitus
Interventions 300 mL Ringer's lactate with 1 mg reteplase versus 300 mL Ringer's lactate alone
Instillation of agent after completion of myomectomy
Outcomes Scoring of adhesions:
  1. Incidence—number of adhesions adherent to uterus or surrounding tissues

  2. Severity—defined as adhesion tenacity score (0 to 3)

  3. Extent—area covered by adhesions in cm²


Adverse effects:
defined as undesirable physical, psychological, or behavioural effects experienced by women
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk No comments regarding allocation concealment—insufficient information to allow judgement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "Same two gynaecologists performed the second‐look laparoscopy and were blinded to the randomisation during both surgical procedures". Not clearly stated whether women blinded to allocation.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The surgeon calculated adhesion scores immediately after surgery. Photographs were taken during myomectomy and videotapes were recorded during early second‐look laparoscopy. A single independent and blinded observer reviewed the photographs and videotapes and made new adhesion scores. These adhesion scores were then compared with the scores from the case record forms made by the two surgeons to ensure consistency of adhesion scoring"
Incomplete outcome data (attrition bias)
All outcomes Low risk 1 participant refused consent for second‐look laparoscopy. No other missing outcome data
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