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Clinical Trial Summary

A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.

Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Incidence of Symptomatic Lymphocele After Kidney Transplantation
  • Lymphocele
  • Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks

NCT number NCT01206868
Study type Interventional
Source Oslo University Hospital
Contact
Status Completed
Phase N/A
Start date March 2007
Completion date May 2009