Clinical Trial: Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative 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.


Detailed Summary:
Sponsor: Oslo University Hospital

Current Primary Outcome: Incidence of symptomatic lymphoceles [ Time Frame: 1 - 3 years ]

Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage


Original Primary Outcome: Same as current

Current Secondary Outcome: Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks [ Time Frame: 1 -10 weeks ]

Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: September 21, 2010
Date Started: March 2007
Date Completion:
Last Updated: September 21, 2010
Last Verified: March 2007