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)
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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
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Interventions |
Treatment group
Control group
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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
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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"
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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 |