Kidney TransplantationNCT00592020
Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation
A study testing Short Transverse Incision and Hockey Stick Incision in people with Kidney Transplantation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Short Transverse Incision and Hockey Stick Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to May 2011
- Phase
- Interventional
- 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
- Age equal or over 18 years
- Sole kidney transplantation
- Consent form
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Inselspital
Bern, Canton of Bern, 3010
About this study
Official title: "Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation
Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).
Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.
The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.
- Conditions
- Kidney Transplantation
- Being tested
- Short Transverse Incision, Hockey Stick Incision
- Keywords
- kidney, transplantation, minimal invasive, short transverse, hockey stick, incision, quality of life, planned kidney transplantation
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Transverse IncisionProcedure or surgery
Short Transverse Incision for kidney transplantation
Hockey Stick IncisionProcedure or surgery
Hockey Stick Incision for kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Short Transverse Incision Receives: Procedure: Short Transverse Incision |
| 2 | Active comparator | Hockey Stick Incision Receives: Procedure: Hockey Stick Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR (Quality of Recovery) - Score
Measured: preoperative, day 1/3/5/7 postoperative
Secondary outcomes (5)
Quality of Life by SF (Short Form) 36
Measured: preoperative, day 7, week 4, month 6 postoperative
Operation time
Measured: intraoperative
Warm ischemic time
Measured: intraoperative
Postoperative pain measured by VAS (visual analog scale) and amount of analgesia
Measured: day 1/2/3/4/5/6/7 postoperative
Surgical complications
Measured: day 7, week 4, month 6, month 12 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Uta Herden, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592020
- Sponsor's protocol ID
- 220/07
- Status last verified
- May 2011
- First submitted
- 31 Dec 2007
- Last updated
- 23 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00592020
- Acronym / sponsor ID
- 220/07
- Conditions
- Kidney Transplantation
- Keywords
- kidney, transplantation, minimal invasive, short transverse, hockey stick, incision, quality of life, planned kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Jan 2008 (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.
Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).
Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.
The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Short Transverse IncisionShort Transverse Incision |
| 2 | Active comparator | Procedure: Hockey Stick IncisionHockey Stick Incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal or over 18 years
- Sole kidney transplantation
- Consent form
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Short Transverse IncisionShort Transverse Incision for kidney transplantation | Procedure or surgery | 1 |
| Hockey Stick IncisionHockey Stick Incision for kidney transplantation | Procedure or surgery | 2 |
Primary outcome
QoR (Quality of Recovery) - Score
Time frame: preoperative, day 1/3/5/7 postoperative
5 secondary outcomes
Quality of Life by SF (Short Form) 36
Time frame: preoperative, day 7, week 4, month 6 postoperative
Operation time
Time frame: intraoperative
Warm ischemic time
Time frame: intraoperative
Postoperative pain measured by VAS (visual analog scale) and amount of analgesia
Time frame: day 1/2/3/4/5/6/7 postoperative
Surgical complications
Time frame: day 7, week 4, month 6, month 12 postoperative
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 23 May 2011.
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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.
Uta Herden, MD principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Transverse Incision and Hockey Stick Incision in people with Kidney Transplantation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 0 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 23 May 2011. 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 Switzerland. 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.
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?
QoR (Quality of Recovery) - Score (time frame: preoperative, day 1/3/5/7 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2011.