Short Transverse Versus Conventional Hockey Stick Incisio... | NCT00592020

Studies
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

NCT00592020

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

May 23, 2011Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Kidney Transplantation

Interventions

Short Transverse Incision
Hockey Stick Incision

Countries

Switzerland

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

May 2011

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

Jan 2008

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Dec 31, 2007

First Submission Date that Met QC Criteria

Dec 31, 2007

First Posted Date

Jan 11, 2008Estimated

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

May 20, 2011

Last Update Posted Date

May 23, 2011Estimated

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

Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).

Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.

The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Short Transverse Incision	Procedure: Short Transverse Incision
2	Active Comparator	Hockey Stick Incision	Procedure: Hockey Stick Incision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Short Transverse Incision	Procedure	Short Transverse Incision for kidney transplantation	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QoR (Quality of Recovery) - Score		preoperative, day 1/3/5/7 postoperative

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life by SF (Short Form) 36		preoperative, day 7, week 4, month 6 postoperative
Operation time		intraoperative
Warm ischemic time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age equal or over 18 years
Sole kidney transplantation
Consent form

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Uta Herden, MD	Insel Gruppe AG, University Hospital Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Inselspital		Bern	Canton of Bern	3010	Switzerland