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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by University Medical Centre Groningen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00258986
First received: November 23, 2005
Last updated: January 31, 2006
Last verified: November 2005
  Purpose

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 Intervention Phase
Living Donors
Procedure: Living donornephrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by University Medical Centre Groningen:

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

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

Estimated Enrollment: 50
Study Start Date: March 2004
Estimated Study Completion Date: December 2006
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258986

Contacts
Contact: Hendrik S Hofker, MD +31(0)50.3616161 ext 12283 h.s.hofker@chir.umcg.nl
Contact: W N Nijboer, MD +31(0)50.3616161 ext 12283 w.n.nijboer@chir.umcg.nl

Locations
Netherlands
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 Centre Groningen
Investigators
Principal Investigator: Rutger J Ploeg, PhD, MD University Medical Centre Groningen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00258986     History of Changes
Other Study ID Numbers: UMCG/166.478/RvB
Study First Received: November 23, 2005
Last Updated: January 31, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
Living donors
Nephrectomy
Kidney transplantation
Randomized Controlled Trial
Laparoscopy

ClinicalTrials.gov processed this record on April 15, 2014