Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT01206868
Status:
COMPLETED
Last Update Posted:
2010-09-22
First Post:
2010-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
Sponsor:
Oslo University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFFEN
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: