Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

This study has been completed.

Sponsor:

Information provided by:

University Hospital Inselspital, Berne

ClinicalTrials.gov Identifier:

NCT00592020

First received: December 31, 2007

Last updated: May 20, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 31, 2007

Last Updated Date

May 20, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

QoR (Quality of Recovery) - Score [ Time Frame: preoperative, day 1/3/5/7 postoperative ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

QoR (Quality of Recovery)- Score [ Time Frame: preoperative, day 1/3/5/7 postoperative ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00592020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of Life by SF (Short Form) 36 [ Time Frame: preoperative, day 7, week 4, month 6 postoperative ] [ Designated as safety issue: No ]
Operation time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
Warm ischemic time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
Postoperative pain measured by VAS (visual analog scale) and amount of analgesia [ Time Frame: day 1/2/3/4/5/6/7 postoperative ] [ Designated as safety issue: No ]
Surgical complications [ Time Frame: day 7, week 4, month 6, month 12 postoperative ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Qualitiy of Life by SF (Short Form) 36 [ Time Frame: preoperative, day 7, week 4, month 6 postoperative ] [ Designated as safety issue: No ]
operation time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
warm ischemic time [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
postoperative pain measured by VAS (visuell analog scale)and amount of analgesia [ Time Frame: day 1/2/3/4/5/6/7 postoperative ] [ Designated as safety issue: No ]
surgical complications [ Time Frame: day 7, week 4, month 6, month 12 postoperative ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

Official Title ^ICMJE

"Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Procedure: Short Transverse Incision
Short Transverse Incision for kidney transplantation
Procedure: Hockey Stick Incision
Hockey Stick Incision for kidney transplantation

Study Arm (s)

Active Comparator: 1
Short Transverse Incision

Intervention: Procedure: Short Transverse Incision
Active Comparator: 2
Hockey Stick Incision

Intervention: Procedure: Hockey Stick Incision

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

May 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age equal or over 18 years
Sole kidney transplantation
Consent form

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00592020

Other Study ID Numbers ^ICMJE

220/07

Has Data Monitoring Committee

Responsible Party

Daniel Inderbitzin, Clinic of Visceral and Transplant Surgery, University Hospital Inselspital, Bern

Study Sponsor ^ICMJE

University Hospital Inselspital, Berne

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Uta Herden, MD

University Hospital Inselspital, Berne

Information Provided By

University Hospital Inselspital, Berne

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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