Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

Incidence of Symptomatic Lymphocele After Kidney Transplantation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206868
• Other study ID #: S-06342a
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: September 21, 2010
• Start date: March 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2007
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: The NorwegianData Inspectorate
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult recipients of kidney transplants from deceased donors

Exclusion Criteria:

• Former extensive abdominal surgery

• Participation in other studies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Incidence of Symptomatic Lymphocele After Kidney Transplantation
• Lymphocele
• Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks

Intervention

Procedure:
• Fenestration
Fenestration of the peritoneum according to the length of the transplanted kidney
• Control
Standard kidney transplantation

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of symptomatic lymphoceles	Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage	1 - 3 years	No
Secondary	Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks		1 -10 weeks	No