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OpenTrials
Completed

NCT Number: NCT01206868

Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

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.

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Key information

Conditions

Incidence of Symptomatic Lymphocele After Kidney Transplantation Cysts Hemic and Lymphatic Diseases Lymphatic Diseases Lymphocele Neoplasms Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult recipients of kidney transplants from deceased donors

Exclusion criteria

  • Former extensive abdominal surgery
  • Participation in other studies

Treatment and study plan

Fenestration

Procedure

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

Control

Procedure

Standard kidney transplantation

Primary outcomes

  1. Incidence of symptomatic lymphoceles

    Time frame: 1 - 3 years

    Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage

Secondary outcomes

  1. Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks

    Time frame: 1 -10 weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles

Acronym: PROFFEN

Important dates

Study start
2007
Study completion
2009
First posted
Sep 22, 2010
Registry last updated
Sep 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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