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. 2019 May 31;2019(5):CD004680. doi: 10.1002/14651858.CD004680.pub3

Chen 2014a.

Methods
  • Study design: parallel RCT

  • Study time frame/recruitment period: March 2008 to December 2012

  • Follow‐up period: mean follow‐up days were 487 in open surgery group (control) and 522 in omental folding group (treatment)

Participants
  • Country: China

  • Setting: single centre

  • Aged 18 to 80 years; initiation of PD; presence of greater omentum below the abdominal incision (accessible through the incision)

  • Number: treatment group (34); control group (33)

  • Mean age ± SD (years): treatment group (51 ± 13); control group (50 ± 14)

  • Sex (M/F): treatment group (16/18); control group (17/16)

  • Diabetes: treatment group (7/34); control group (7/33)

  • Exclusion criteria: previous open abdominal surgery history; history of psychological illness or condition that interfered with the ability to understand or comply with requirements of the study

Interventions Treatment group
  • Open insertion of PD catheter with omentum folding (where a 2 cm incision was made in the peritoneum and the greater omentum was gently drawn out of the abdominal cavity. The distal corners of the greater omentum were fixed to the proximal (gastrocolic) parts of the omentum with three stitches of 2‐0 silk suture)


Control group
  • Regular open insertion of PD catheter

Outcomes
  • Catheter tip migration with drainage failure

  • Irreversible catheter dysfunction

  • All‐cause catheter failure: defined as necessary to remove or reposition the catheter by surgical methods

  • First catheter‐related infections including peritonitis, exit‐site infection, and tunnel infection

  • Technique survival: defined as time to permanent transfer to HD or kidney transplant

Notes
  • Additional data requested from authors: yes

  • Funding source: " This work was supported in part by the Research Award Fund for Young Teachers in Central South University (2011QNZT165) to G.C. and the National Natural Science Foundation of China (No. 81070610) to F.L"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) Low risk All the outcomes are reported
Other bias High risk Assessment of presence of greater omentum was only possible during operation hence it is unclear randomisation was occurred after surgical incision was made