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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: "Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation

Resource links provided by NLM:

U.S. FDA Resources

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 ]
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Short Transverse Incision
 Procedure: Short Transverse Incision
Short Transverse Incision for kidney transplantation
Active Comparator: 2
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

Locations
Switzerland
University Hospital Inselspital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Uta Herden, MD University Hospital Inselspital, Berne
  More Information

No publications provided

Responsible Party: Daniel Inderbitzin, Clinic of Visceral and Transplant Surgery, University Hospital Inselspital, Bern
ClinicalTrials.gov Identifier: NCT00592020     History of Changes
Other Study ID Numbers: 220/07
Study First Received: December 31, 2007
Last Updated: May 20, 2011
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

ClinicalTrials.gov processed this record on June 18, 2013