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

March 1, 2024 updated by: University Medical Center Groningen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
- 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Rutger J Ploeg, PhD, MD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

November 23, 2005

First Submitted That Met QC Criteria

November 23, 2005

First Posted (Estimated)

November 28, 2005

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UMCG/166.478/RvB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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