NCT00258986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 4, 2024

Status Verified

March 1, 2024

First QC Date

November 23, 2005

Last Update Submit

March 1, 2024

Conditions

Living Donors

Keywords

Living donorsNephrectomyKidney transplantationRandomized Controlled TrialLaparoscopy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • - 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)

Interventions

Living donornephrectomyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Accepted as living kidney donor by local protocol
  • 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

You may not qualify if:

  • Previous surgery using subcostal incision(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • Smit M, Hofker HS, Leuvenink HG, Krikke C, Jongman RM, Zijlstra JG, van Meurs M. A human model of intra-abdominal hypertension: even slightly elevated pressures lead to increased acute systemic inflammation and signs of acute kidney injury. Crit Care. 2013 Apr 4;17(2):425. doi: 10.1186/cc12568. No abstract available.

    PMID: 23566574DERIVED

Study Officials

  • Rutger J Ploeg, PhD, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 28, 2005

Study Start

March 1, 2004

Study Completion

December 1, 2006

Last Updated

March 4, 2024

Record last verified: 2024-03

Locations

NL(1)