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. 2024 Mar 12;2024(3):CD014763. doi: 10.1002/14651858.CD014763.pub2

Alvandipour 2016.

Study characteristics
Methods Design: parallel‐group RCT
Study period: February 2015–May 2015
Participants Setting: elective general or colorectal surgery
Type of stoma: ileostomy
Inclusion criteria
  • Age ≥ 18 years

  • Colorectal cancer

  • Protective ileostomy after surgery

  • Benign condition that required ileostomy


Exclusion criteria
  • Death or dropout

  • Need for secondary surgery at other centres

Interventions PSSC using subcuticular absorbable suture (n = 34) versus LSC using interrupted non‐absorbable suture (n = 32). No mesh or drain was used during closure in either group.
Outcomes
  • SSI (any infection of the superficial or deep tissues or the organ/space affected by the surgery when no prosthesis has been implanted) as identified by a surgeon in the outpatient clinic within 30 days of surgery

  • Operating time

  • Length of hospital stay

  • Postoperative pain (VAS) at 3 days, 7 days, 1 month, and 3 months after surgery

  • Participant satisfaction with the wound or scar (VAS) at 3 days, 7 days, 1 month, and 3 months after surgery

Notes The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 3 months. The study received no external funding, and the protocol had been registered with the Iranian Registry of Clinical Trials (registration number: IRCT2015040714483N3). The study authors declared no conflicts of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Article describes method of randomisation but not type of randomisation.
Allocation concealment (selection bias) High risk Method used for randomisation is not recognised to support allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and personnel were not blinded (blinding may not be practical in this setting).
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcome assessment was not blinded (blinding may not be practical in this setting).
Incomplete outcome data (attrition bias)
All outcomes Low risk Complete outcome data for all participants.
Selective reporting (reporting bias) Low risk No selective reporting detected.
Other bias Low risk No other sources of bias detected.