Back to resultsProphylactic Fenestration of the Peritoneum in Kidney Transplantation (PROFFEN)
Primary Purpose
Incidence of Symptomatic Lymphocele After Kidney Transplantation, Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Fenestration
Control
Sponsored by
About this trial
This is an interventional treatment trial for Incidence of Symptomatic Lymphocele After Kidney Transplantation focused on measuring kidney, transplantation, surgery, complications, lymphocele, fluid collections.
Eligibility Criteria
Inclusion Criteria:
- Adult recipients of kidney transplants from deceased donors
Exclusion Criteria:
- Former extensive abdominal surgery
- Participation in other studies
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Fenestration
Control
Arm Description
Fenestration of the peritoneum according to the length of the transplanted kidney
Standard kidney transplantation
Outcomes
Primary Outcome Measures
Incidence of symptomatic lymphoceles
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
Full Information
NCT ID
NCT01206868
First Posted
September 21, 2010
Last Updated
September 21, 2010
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01206868
Brief Title
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
Acronym
PROFFEN
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 Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incidence of Symptomatic Lymphocele After Kidney Transplantation, Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
Keywords
kidney, transplantation, surgery, complications, lymphocele, fluid collections.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenestration
Arm Type
Active Comparator
Arm Description
Fenestration of the peritoneum according to the length of the transplanted kidney
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Standard kidney transplantation
Intervention Type
Procedure
Intervention Name(s)
Fenestration
Intervention Description
Fenestration of the peritoneum according to the length of the transplanted kidney
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Standard kidney transplantation
Primary Outcome Measure Information:
Title
Incidence of symptomatic lymphoceles
Description
Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage
Time Frame
1 - 3 years
Secondary Outcome Measure Information:
Title
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks
Time Frame
1 -10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult recipients of kidney transplants from deceased donors
Exclusion Criteria:
Former extensive abdominal surgery
Participation in other studies
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
21597401
Citation
Syversveen T, Midtvedt K, Brabrand K, Oyen O, Foss A, Scholz T. Prophylactic peritoneal fenestration to prevent morbidity after kidney transplantation: a randomized study. Transplantation. 2011 Jul 27;92(2):196-202. doi: 10.1097/TP.0b013e318220f57b.
Results Reference
derived
Learn more about this trial
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
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