Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00592020
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : May 23, 2011
Information provided by:
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Procedure: Short Transverse Incision Procedure: Hockey Stick Incision Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: "Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation
Study Start Date : January 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. QoR (Quality of Recovery) - Score [ Time Frame: preoperative, day 1/3/5/7 postoperative ]

Secondary Outcome Measures :
  1. Quality of Life by SF (Short Form) 36 [ Time Frame: preoperative, day 7, week 4, month 6 postoperative ]
  2. Operation time [ Time Frame: intraoperative ]
  3. Warm ischemic time [ Time Frame: intraoperative ]
  4. Postoperative pain measured by VAS (visual analog scale) and amount of analgesia [ Time Frame: day 1/2/3/4/5/6/7 postoperative ]
  5. Surgical complications [ Time Frame: day 7, week 4, month 6, month 12 postoperative ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age equal or over 18 years
  • Sole kidney transplantation
  • Consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00592020

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

Responsible Party: Daniel Inderbitzin, Clinic of Visceral and Transplant Surgery, University Hospital Inselspital, Bern Identifier: NCT00592020     History of Changes
Other Study ID Numbers: 220/07
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: May 2011

Keywords provided by University Hospital Inselspital, Berne:
minimal invasive
short transverse
hockey stick
quality of life
planned kidney transplantation

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries