Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation - Full Text View

Sponsored by:	University Hospital Inselspital, Berne
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00592020

Purpose

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.

Condition	Intervention
Kidney Transplantation	Procedure: Short Transverse Incision Procedure: Hockey Stick Incision

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	"Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Quality of Life by SF (Short Form) 36 [ Time Frame: preoperative, day 7, week 4, month 6 postoperative ] [ Designated as safety issue: No ]
Pperation 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 ]

Estimated Enrollment:	50
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Short Transverse Incision	Procedure: Short Transverse Incision Short Transverse Incision for kidney transplantation
2: Active Comparator Hockey Stick Incision	Procedure: Hockey Stick Incision Hockey Stick Incision for kidney transplantation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age equal or over 18 years
Sole kidney transplantation
Consent form

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592020

Contacts

Contact: Stefan W Schmid, Medical Doctor

0041316322111

stefan.schmid@insel.ch

Locations

Switzerland
University Hospital Inselspital	Recruiting
Berne, Switzerland, 3010
Contact: Stefan W Schmid, MD +41316322111 stefan.schmid@insel.ch
Principal Investigator: Stefan W Schmid, MD

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator:

Uta Herden, MD

University Hospital Inselspital, Berne

More Information

Responsible Party:	Clinic of Visceral and Transplant Surgery, University Hospital Inselspital, Bern ( Stefan Schmid )
Study ID Numbers:	220/07
Study First Received:	December 31, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00592020
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

kidney
transplantation
minimal invasive
short transverse

hockey stick
incision
quality of life
planned kidney transplantation

Study placed in the following topic categories:

Quality of Life

ClinicalTrials.gov processed this record on January 16, 2009