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

Amano 2019.

Study characteristics
Methods Design: parallel‐group RCT
Study period: November 2007–September 2016
Participants Setting: elective general or colorectal surgery
Type of stoma: ileostomy or colostomy
Inclusion criteria
  • Age ≥ 18 years

  • Elective stoma reversal

  • Ability to provide voluntary informed consent for participation


Exclusion criteria
  • Parastomal hernia requiring intensive repair

  • Double stomas located close to each other

  • Refusal to provide consent for participation in the trial

Interventions PSSC using subcuticular absorbable suture (n = 89) versus LSC using interrupted non‐absorbable suture plus use of wound drain (n = 79). Wound drain was used in the LSC group but no mesh was used during closure in either group.
Outcomes
  • Wound healing 30 days after surgery

  • SSI at the stoma site 30 days after surgery (diagnosed by the presence of erythema, pain, swelling or discharge at or around the stoma site

Notes The 2 groups were comparable in terms of baseline demographics (age, sex, BMI) and comorbidities. The length of follow‐up was 1 month. The study received no external funding, and the protocol had been registered with University Hospital Medical Information Network (registration number: UMIN000030772). The study authors declared no conflicts of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Method and type of randomisation described appropriately.
Allocation concealment (selection bias) Low risk Method used for randomisation supports 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.