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Prophylactic Fenestration of the Peritoneum in Kidney Transplantation (PROFFEN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206868
First Posted: September 22, 2010
Last Update Posted: September 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  Purpose

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 Intervention
Incidence of Symptomatic Lymphocele After Kidney Transplantation Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks Procedure: Fenestration Procedure: Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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


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

Enrollment: 130
Study Start Date: March 2007
Study Completion Date: May 2009
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: September 21, 2010
First Posted: September 22, 2010
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