Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

NCT ID: NCT01206868

Last Updated: 2010-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fenestration

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

Group Type ACTIVE_COMPARATOR

Fenestration

Intervention Type PROCEDURE

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

Control

Standard kidney transplantation

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Standard kidney transplantation

Interventions

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Fenestration

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

Intervention Type PROCEDURE

Control

Standard kidney transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult recipients of kidney transplants from deceased donors

Exclusion Criteria

* Former extensive abdominal surgery
* Participation in other studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Section for Transplant Surgery, Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 21597401 (View on PubMed)

Other Identifiers

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S-06342a

Identifier Type: -

Identifier Source: org_study_id