Prophylactic Fenestration of the Peritoneum in Kidney Tra... | NCT01206868

Studies
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

NCT01206868

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Sep 22, 2010Estimated

Enrollment

130Actual

Phase

Not Applicable

Conditions

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

Interventions

Fenestration
Control

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

May 2009Actual

First Submitted Date

Sep 21, 2010

First Submission Date that Met QC Criteria

Sep 21, 2010

First Posted Date

Sep 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2010

Last Update Posted Date

Sep 22, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fenestration	Active Comparator	Fenestration of the peritoneum according to the length of the transplanted kidney	Procedure: Fenestration
Control	Sham Comparator	Standard kidney transplantation	Procedure: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fenestration	Procedure	Fenestration of the peritoneum according to the length of the transplanted kidney	Fenestration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of symptomatic lymphoceles	Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage	1 - 3 years

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks		1 -10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult recipients of kidney transplants from deceased donors

Exclusion Criteria:

Former extensive abdominal surgery
Participation in other studies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0027	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21597401	Derived	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.

ID	Term
D003560	Cysts
D009369	Neoplasms
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D013506	Otologic Surgical Procedures
D013517	Otorhinolaryngologic Surgical Procedures
D013514	Surgical Procedures, Operative