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Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

Not Applicable
Completed
Conditions
Incidence of Symptomatic Lymphocele After Kidney Transplantation
Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
Interventions
Procedure: Fenestration
Procedure: Control
Registration Number
NCT01206868
Lead Sponsor
Oslo University Hospital
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
130
Inclusion Criteria
  • Adult recipients of kidney transplants from deceased donors
Exclusion Criteria
  • Former extensive abdominal surgery
  • Participation in other studies

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FenestrationFenestrationFenestration of the peritoneum according to the length of the transplanted kidney
ControlControlStandard kidney transplantation
Primary Outcome Measures
NameTimeMethod
Incidence of symptomatic lymphoceles1 - 3 years

Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage

Secondary Outcome Measures
NameTimeMethod
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks1 -10 weeks

Trial Locations

Locations (1)

Oslo University Hospital

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Oslo, Norway

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