Incidence of Symptomatic Lymphocele After Kidney TransplantationPROFFENNCT01206868
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation
A study testing Fenestration in people with Incidence of Symptomatic Lymphocele After Kidney Transplantation and Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks, run by Oslo University Hospital at 1 site in Norway.
Trial summary
A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation. Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incidence of Symptomatic Lymphocele After Kidney Transplantation, Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
- What is being tested?
- Fenestration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to May 2009
- 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
- Adult recipients of kidney transplants from deceased donors
Who cannot join
- Former extensive abdominal surgery
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles
A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.
Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.
- Conditions
- Incidence of Symptomatic Lymphocele After Kidney Transplantation, Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
- Being tested
- Fenestration, Control
- Keywords
- kidney, transplantation, surgery, complications, lymphocele, fluid collections.
- Medical subject headings
- Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenestrationProcedure or surgery
Fenestration of the peritoneum according to the length of the transplanted kidney
ControlProcedure or surgery
Standard kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| Fenestration | Active comparator | Fenestration of the peritoneum according to the length of the transplanted kidney Receives: Procedure: Fenestration |
| Control | Sham comparator | Standard kidney transplantation Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic lymphoceles
Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage
Measured: 1 - 3 years
Secondary outcomes (1)
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks
Measured: 1 -10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startMar 2007
- Study completionMay 2009
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 Incidence of Symptomatic Lymphocele After Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206868
- Sponsor's protocol ID
- S-06342a
- Acronym
- PROFFEN
- Status last verified
- Mar 2007
- First submitted
- 21 Sep 2010
- Last updated
- 22 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Syversveen T, Midtvedt K, Brabrand K, Oyen O, Foss A, Scholz T. Prophylactic peritoneal fenestration to prevent morbidity after kidney transplantation: a randomized study. Transplantation. 2011 Jul 27;92(2):196-202. doi: 10.1097/TP.0b013e318220f57b.
PubMed 21597401
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Randomized Study to Evaluate the Efficiency of Prophylactic Fenestration of the Peritoneum in Kidney Transplantation in Preventing the Occurrence of Postoperative Lymphoceles
- ClinicalTrials.gov ID
- NCT01206868
- Acronym / sponsor ID
- PROFFEN / S-06342a
- Conditions
- Incidence of Symptomatic Lymphocele After Kidney Transplantation, Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks
- Keywords
- kidney, transplantation, surgery, complications, lymphocele, fluid collections.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- May 2009 (actual)
- First posted
- 22 Sep 2010 (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.
A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.
Adult (>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenestration | Active comparator | Procedure: FenestrationFenestration of the peritoneum according to the length of the transplanted kidney |
| Control | Sham comparator | Procedure: ControlStandard kidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult recipients of kidney transplants from deceased donors
Key exclusion criteria (2 listed)
- Former extensive abdominal surgery
- Participation in other studies
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 |
|---|---|---|
| FenestrationFenestration of the peritoneum according to the length of the transplanted kidney | Procedure or surgery | Fenestration |
| ControlStandard kidney transplantation | Procedure or surgery | Control |
Primary outcome
Incidence of symptomatic lymphoceles
Time frame: 1 - 3 years
Symptomatic lymphoceles treated by surgical intervetion or ultrasound guided drainage
1 secondary outcome
Prevalence of fluid perirenal collections evaluated by ultrasound at 1, 5 and 10 weeks
Time frame: 1 -10 weeks
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 22 Sep 2010.
- Derived from this study: PubMed 21597401Syversveen T, Midtvedt K, Brabrand K, Oyen O, Foss A, Scholz T. Prophylactic peritoneal fenestration to prevent morbidity after kidney transplantation: a randomized study. Transplantation. 2011 Jul 27;92(2):196-202. doi: 10.1097/TP.0b013e318220f57b.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenestration in people with Incidence of Symptomatic Lymphocele After Kidney Transplantation and Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks, run by Oslo University Hospital at 1 site in Norway.
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 1 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 22 Sep 2010. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
Incidence of symptomatic lymphoceles (time frame: 1 - 3 years). 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 NCT01206868, 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 22 Sep 2010.