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Prophylactic Fenestration of the Peritoneum in Kidney Transplantation (PROFFEN)

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01206868
First received: September 21, 2010
Last updated: NA
Last verified: March 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Incidence of symptomatic lymphoceles [ Time Frame: 1 - 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206868

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

No publications provided by Oslo University Hospital

Additional 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
Study First Received: September 21, 2010
Last Updated: September 21, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: The NorwegianData Inspectorate

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

Additional relevant MeSH terms:
Lymphocele
Cysts
Neoplasms
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013