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. 2018 Nov 29;2018(11):CD011274. doi: 10.1002/14651858.CD011274.pub2

Turner 1994.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 3 POD

Participants
  • Country: Australia

  • Setting: single centre

  • Inclusion criteria: patients undergoing elective open cholecystectomy

  • Number: treatment group (24); control group (24)

  • Mean age ± SD (years): treatment group (56.5 ± 16.6); control group (49.0 ± 15.3)

  • Sex (M/F): treatment group (8/16); control group (10/14)

  • Exclusion criteria: history of peptic ulceration; bleeding disorder; kidney impairment; haemorrhoids

Interventions Treatment group
  • Indomethacin suppositories: 200 mg at end of surgery then 100 mg twice daily for 3 days


Control group
  • Placebo suppositories: according to same treatment regimen.

Outcomes
  • Pre‐operative and post‐operative (48 h) SCr was measured in 19/50 patients

Notes
  • No pre‐operative and post‐operative SCr measures given, rather the mean change was given for each group

  • Funding Source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised, method of randomisation was not reported
Allocation concealment (selection bias) Low risk Sequential selection of previously randomised envelopes, study drugs appearing identical
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients, nursing staff and medical staff were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Patients, nursing staff and medical staff were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 50 patients were included in the study, 2 patients were withdrawn due to protocol violation. Of the remaining 48 patients kidney outcome data was available from 38 patients (11% missing data). No reasons for missing data was provided
Selective reporting (reporting bias) Low risk Study protocol matches outcomes presented
Other bias Unclear risk Insufficient information to permit judgement