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Efficacy Study Comparing Hand-Assisted Laparoscopic and Mini-Incision Muscle Splitting Incision Living Donor Nephrectomy

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: NCT00258986
Recruitment Status : Unknown
Verified November 2005 by University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : November 28, 2005
Last Update Posted : February 1, 2006
Information provided by:
University Medical Center Groningen

Brief Summary:
The purpose of this study is to compare the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors. The hypothesis is that the mini-incision is not inferior to the laparoscopic technique.

Condition or disease Intervention/treatment Phase
Living Donors Procedure: Living donornephrectomy Phase 3

Detailed Description:

Living kidney donation has become an important source for kidney transplantation because of insufficient numbers of post mortem kidney donations. To reduce the surgical trauma of the donor operation and improve postoperative recovery minimal invasive techniques have developed. Especially the laparoscopic and the hand-assisted laparoscopic technique gained wide popularity. Minimal invasive open techniques have had less publicity. One of those open techniques is to perform the open donornephrectomy by means of an anterolateral approach. A transverse subcostal incision of 10 cm or less is made. The abdominal wall is opened by splitting the muscles and sparing the nerves. Staying in the retroperitoneal space the kidney is freed and taken out. Laparoscopic approaches have especially become more popular after the hand-assisted technique had developed. By means of an 8 cm transverse suprapubic skin incision and a vertical midline fascia incision the abdominal cavity is opened and a hand is inserted in the abdomen through an air tight sleeve. Three more trocarts are needed for the insufflation, the video camera and surgical instruments to perform a transperitoneal donornephrectomy. The hand in the abdomen assisting in the procedure has especially increased the sense of safety compared to the full laparoscopic technique without compromising the advantages of the laparoscopic technique.

So far no prospective or retrospective study has been done comparing the hand-assisted laparoscopic with the mini-incision muscle-splitting technique. Most studies that have been done comparing the (hand-assisted) laparoscopic technique with more invasive open techniques resulted in favour of the former technique.

Comparison(s): The study compares the effects of hand-assisted laparoscopic and mini-incision muscle-splitting donornephrectomy on living kidney donors.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : March 2004
Study Completion Date : December 2006

Primary Outcome Measures :
  1. Triple pain measurement using linear Visual Analogue Scale (at rest, at coughing and in supine position lifting of straight legs)

Secondary Outcome Measures :
  1. - CRP levels in first three days after the donor operation (indicative of the magnitude of the surgical trauma)
  2. - Abdominal wall muscle function (testing the functional integrity of the abdominal muscles)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Accepted as living kidney donor by local protocol
  • 18 years or older
  • Excellent understanding of Dutch language
  • Able to be operated on by both surgical techniques
  • Having read patient information and signed informed consent

Exclusion Criteria:

  • Previous surgery using subcostal incision(s)
  • Not meeting the inclusion criteria

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): NCT00258986

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Contact: Hendrik S Hofker, MD +31(0)50.3616161 ext 12283
Contact: W N Nijboer, MD +31(0)50.3616161 ext 12283

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University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Sub-Investigator: Hendrik S Hofker, MD         
Sub-Investigator: W N Nijboer, MD         
Sponsors and Collaborators
University Medical Center Groningen
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Principal Investigator: Rutger J Ploeg, PhD, MD University Medical Center Groningen

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00258986    
Other Study ID Numbers: UMCG/166.478/RvB
First Posted: November 28, 2005    Key Record Dates
Last Update Posted: February 1, 2006
Last Verified: November 2005
Keywords provided by University Medical Center Groningen:
Living donors
Kidney transplantation
Randomized Controlled Trial