Living DonorsPhase 3NCT00258986
Efficacy Study Comparing Hand-assisted Laparoscopic and Mini-incision Muscle Splitting Incision Living Donor Nephrectomy
A Phase 3 study testing Living donornephrectomy in people with Living Donors, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Living Donors
- What is being tested?
- Living donornephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous surgery using subcostal incision(s)
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Living Donors
- Being tested
- Living donornephrectomy
- Keywords
- Living donors, Nephrectomy, Kidney transplantation, Randomized Controlled Trial, Laparoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living donornephrectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startMar 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Living DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Rutger J Ploeg, PhD, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258986
- Sponsor's protocol ID
- UMCG/166.478/RvB
- Status last verified
- Mar 2024
- First submitted
- 23 Nov 2005
- Last updated
- 4 Mar 2024
- Results posted
- No
Publications
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.
PubMed 23566574
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study Comparing Hand-assisted Laparoscopic and Mini-incision Muscle Splitting Incision Living Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT00258986
- Acronym / sponsor ID
- UMCG/166.478/RvB
- Conditions
- Living Donors
- Keywords
- Living donors, Nephrectomy, Kidney transplantation, Randomized Controlled Trial, Laparoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Previous surgery using subcostal incision(s)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living donornephrectomy | Procedure or surgery | – |
Primary outcome
Triple pain measurement using linear Visual Analogue Scale (at rest, at coughing and in supine position lifting of straight legs)
2 secondary outcomes
- 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 23566574Smit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rutger J Ploeg, PhD, MD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Living donornephrectomy in people with Living Donors, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triple pain measurement using linear Visual Analogue Scale (at rest, at coughing and in supine position lifting of straight legs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00258986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.