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CompletedNCT01206868PROFFENUpdated Sep 22, 2010

Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

An interventional study of Fenestration and Control in Incidence of Symptomatic Lymphocele After Kidney Transplantation and Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-22.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • kidney, transplantation, surgery, complications, lymphocele, fluid collections.
03

In context

Lymphocele

27 studies on the registry are indexed under Lymphocele; 3 are open to participants now.

This study's enrollment of 130 is above the median of 100 across 24 interventional studies indexed under Lymphocele.

Browse Lymphocele studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult recipients of kidney transplants from deceased donors

Exclusion criteria

Exclusion Criteria:

  • Former extensive abdominal surgery
  • Participation in other studies
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Fenestration

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

    Procedure: Fenestration

  • Sham comparator
    Control

    Standard kidney transplantation

    Procedure: Control

Interventions

  • ProcedureFenestration

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

  • ProcedureControl

    Standard kidney transplantation

06

What researchers measure

Primary outcomes

  1. Incidence of symptomatic lymphoceles

    Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage

    Time frame: 1 - 3 years

Secondary outcomes

  1. Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks

    Time frame: 1 -10 weeks

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, 0027, Norway
08

References and documents

Publications

  • 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. PubMed 21597401 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01206868
Lead sponsor
Oslo University Hospital
First posted
Sep 22, 2010
Start date
Mar 2007
Completion
May 2009
Last update
Sep 22, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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