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Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01206868
Acronym
PROFFEN
Enrollment
130
Registered
2010-09-22
Start date
2007-03-31
Completion date
2009-05-31
Last updated
2010-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

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.

Interventions

PROCEDUREFenestration

Fenestration of the peritoneum according to the length of the transplanted kidney

PROCEDUREControl

Standard kidney transplantation

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult recipients of kidney transplants from deceased donors

Exclusion criteria

* Former extensive abdominal surgery * Participation in other studies

Design outcomes

Primary

MeasureTime frameDescription
Incidence of symptomatic lymphoceles1 - 3 yearsSymptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage

Secondary

MeasureTime frame
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks1 -10 weeks

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026