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Prophylactic Fenestration of the Peritoneum in Kidney Transplantation (PROFFEN)

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ClinicalTrials.gov Identifier: NCT01206868
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : September 22, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Incidence of Symptomatic Lymphocele After Kidney Transplantation Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks Procedure: Fenestration Procedure: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Lymphoceles
Study Start Date : March 2007
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Fenestration
Fenestration of the peritoneum according to the length of the transplanted kidney
Procedure: Fenestration
Fenestration of the peritoneum according to the length of the transplanted kidney
Sham Comparator: Control
Standard kidney transplantation
Procedure: Control
Standard kidney transplantation



Primary Outcome Measures :
  1. Incidence of symptomatic lymphoceles [ Time Frame: 1 - 3 years ]
    Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage


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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult recipients of kidney transplants from deceased donors

Exclusion Criteria:

  • Former extensive abdominal surgery
  • Participation in other studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206868


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tim Scholz MD, PhD. Principal Investigator, Section for Transplant Surgery, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01206868     History of Changes
Other Study ID Numbers: S-06342a
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: March 2007

Keywords provided by Oslo University Hospital:
kidney, transplantation, surgery, complications, lymphocele, fluid collections.

Additional relevant MeSH terms:
Lymphocele
Cysts
Neoplasms
Lymphatic Diseases