Prophylactic Fenestration of the Peritoneum in Kidney Transplantation (PROFFEN)

University of Oslo (UIO)

Status: Completed

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

Treatments: Procedure: Control; Procedure: Fenestration

Study type: Interventional

Funder types: Other

Identifiers

NCT01206868

S-06342a

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult recipients of kidney transplants from deceased donors

Exclusion criteria

• Former extensive abdominal surgery
• Participation in other studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

Fenestration

Active Comparator group

Description:

Fenestration of the peritoneum according to the length of the transplanted kidney

Treatment:

Procedure: Fenestration

Control

Sham Comparator group

Description:

Standard kidney transplantation

Treatment:

Procedure: Control