Kidney TransplantationPREFENNCT03682627
Preventive Fenestration With and Without Clipping in Kidney Transplantation
A study testing Fenestration and Fenestration and clipping in people with Kidney Transplantation, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Post-Kidney Transplantation Lymphatic complications include lymphorrhea and lymphocele, and are some of the most challenging issues after kidney transplantation. The most frequent post-Kidney transplantation complication is accumulation of perirenal fluids, such as urinomas, hematomas, and lymphoceles. 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?
- Fenestration and Fenestration and clipping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2018to Dec 2020
- 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 > 18 years
- Provide written informed consent
- Recipients of KTx from deceased donors
Who cannot join
- Inability to comply with study and/or follow-up procedures
- Recipients of KTx from living donors
- Combined transplantation (e.g. pancreas-kidney transplantation)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: PREventive Effect of FENestration With and Without Clipping on Post-Kidney Transplantation Lymphatic Complications: PREFEN Trial
Post-Kidney Transplantation Lymphatic complications include lymphorrhea and lymphocele, and are some of the most challenging issues after kidney transplantation. The most frequent post-Kidney transplantation complication is accumulation of perirenal fluids, such as urinomas, hematomas, and lymphoceles. Lymphoceles are associated with morbidities such as abdominal discomfort, impaired wound healing, and thrombosis. Lymphoceles may also affect graft function by putting direct pressure on the kidney, or by compressing the ureter or transplant vasculature. The frequency and consequences of post-transplantation lymphoceles make preventive measures highly desirable. Peritoneal fenestration during kidney Transplantation is a simple method for preventing lymphocele formation. Recent studies have evaluated the effectiveness of clipping with metallic clips following fenestration on lymphocele formation and lymph leakage after prostate cancer surgery and laparoscopic retroperitoneal lymph node dissection. However, whether clipping prevents lymphocele formation after kidney transplantation has not been investigated. The aim of the proposed study is to compare the effect of fenestration with and without clipping on incidence of post-kidney transplantation lymphocele and lymphorrhea.
Read the detailed description
Recent improvements in transplantation techniques, organ matching systems, and modern immunosuppressive regiments have made kidney transplantation a routine operation with acceptable mortality and morbidity rates. Post-kidney transplantation morbidities include vascular and urological complications, and postoperative fluid collections. Perirenal fluid collections, such as urinomas, hematomas, and lymphoceles, are some of most frequent complications following Kidney transplantation, among which post-Kidney transplantation lymphatic collections, are most challenging complications.
The incidence of post-kidney transplantation lymphatic complications is up to 50% and the peak incidence of lymphocele is during the 6th postoperative week (range: 2 weeks to 6 months).
Lymphoceles are usually asymptomatic and identified incidentally by routine ultrasound examination. However lymphoceles may result in morbidities such as abdominal discomfort, impaired wound healing, and thrombosis. Post-kidney transplantation lymphatic complications may also affect graft function by putting pressure on the kidney, or by compressing the ureter or transplant vasculature. The frequency and consequences of post-transplantation lymphoceles make preventive measures highly desirable.
Various preventive methods have been proposed in the literature. Lymphoceles usually originate from unligated lymphatic vessels, therefore precise ligation of donor and recipient lymphatic vessels can reduce lymphocele formation. Compression therapy of the lower limb after kidney transplantation and appropriate immunosuppressive therapy may also reduce lymphocele formation. Some authors have used polymeric sealants/hemostatic biomaterials or povidone-iodine to prevent lymphocele formation. However, the effectiveness and cost-efficiency of these methods has not been conclusively proven. Use of drains in lymphocele prevention has also been previously suggested, but this method remains controversial. Peritoneal fenestration at the time of kidney transplantation is a simple method to prevent lymphocele formation. This method has been widely studied in treatment and prevention of lymphoceles following kidney transplantation. However, to the best of our knowledge, only one randomized controlled trial has been performed to investigate the impact of preventive fenestration in prevention of post kidney transplantation lymphatic complications. This study showed that the prevalence of fluid collections in the fifth postoperative week was significantly higher in the standard group compared to fenestration group. Also, 15.5% of patients in the standard group developed symptomatic lymphoceles requiring treatment during the first postoperative year, versus 3.0% in the fenestration group.
Recent studies have evaluated the effectiveness of extensive clipping using metallic clips following fenestration on lymphocele formation and lymph leakage after prostate cancer surgery and laparoscopic retroperitoneal lymph node dissection. Some surgeons have declared concerns that larger fenestrations increase the risk of hernia. However, risk of closure of the peritoneal fenestration is higher for smaller Windows in the peritoneal cavity. Recently clipping of the edges of peritoneal fenestration was performed in the surgical clinic of the Heidelberg University Hospital to reduce risk of closure of the fenestration after kidney transplantation. However, whether fenestration and clipping prevents lymphocele formation after kidney transplantation has not been investigated.
This clinical Trial is designed to investige the rate of post-kidney transplantation lymphocele and lymphorrhea in two groups of kidney transplantation patients: one with only fenestration and one with fenestration and clipping of the edges. Additionally, graft function and incidence rate of other morbidities will be investigated and analyzed after transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Fenestration, Fenestration and clipping
- Keywords
- kidney transplantation, Lymphatic complications, preventive fenestration, clipping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenestrationProcedure or surgery
A standardized fenestration of the peritoneum will be performed. A 2 cm incision will be made in the peritoneum that is parallel to the skin incision after the transplant procedure. The peritoneal will not be sutured at the edges to keep the fenestration open. No interpositioning of the omentum will be performed.
Fenestration and clippingProcedure or surgery
A standardized fenestration of the peritoneum will be performed. A 2 cm incision will be made in the peritoneum that is parallel to the skin incision after the transplant procedure. The window edges will be clipped after fenestration using 8 metal clips.
| Study group | Role | What they receive |
|---|---|---|
| preventive fenestration | Active comparator | Fenestration is performed at the time of kidney transplantation Receives: Procedure: Fenestration |
| preventive fenestration and clipping | Experimental | Fenestration and clipping of the edges are performed at the time of kidney transplantation Receives: Procedure: Fenestration and clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post kidney transplantation lymphocele
Fluid collection of variable size located near to the transplanted kidney in a non-epithelialized cavity. The possibility that the accumulation of fluid is a hematoma, abscess, and urinoma will be ruled out after aspiration of the fluid.
Measured: 6 months
Secondary outcomes (17)
Operation time
From skin incision to skin closure
Measured: 1 day
Estimated blood loss
Blood loss during operation from skin incision to skin closure (mL)
Measured: 1 day
Length of hospital stay
From the time of the operation to time of discharge
Measured: 6 months
Postoperative complications
Postoperative complications will be reported and classified according to the Clavien-Dindo classification.
Measured: 6 months
Mortality
Death due to any cause.
Measured: 90 days
Post Kidney transplantation fluid collection
Fluid accumulation near to the transplanted kidney will be diagnosed by ultrasound as routine of the Heidelberg
Measured: 6 months
Post Kidney transplantation lymphorrhea
Defined as an outflow of more than 50 (milileter) of fluid per day after the 7th post-KTx day. Fluid that flows from the drain, or the site of the removed drain, or surgical wound, which is not blood, pus, or urine will be monitored
Measured: 6 months
Lymphocele size
Lymphocele diameter and volume will be recorded by ultrasound examination in mL.
Measured: 6 months
Lymphocele symptomes
Measured: 6 months
Lymphocele/lymphorrhea severity grade
Severity of lymphocele/lymphorrhea will be graded based on the applied management strategy (Grade A: Observation, Grade B: Non-surgical intervention, Grade C: Surgery).
Measured: 6 months
Blood Urea Nitrogen Level
Blood Urea Nitrogen Level (mg/dL)
Measured: 6 months
Plasma uric acid Level
Plasma uric acid Level (mg/dL)
Measured: 6 months
Serum creatinine level
Serum creatinine level (mg/dL)
Measured: 6 months
Rate of delayed graft function
Is defined as the need for one or more hemodialysis treatments following transplantation prior to the onset of graft function.
Measured: 30 days
Glomerular filtration rate
GFR (mL/min/1.73 m2) calculated with "175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female)" Formula
Measured: 6 months
Rate of primary non-function grafts
number of recipients whose grafts never functions after transplantation
Measured: 30 days
Retransplantion rate
Rate of retransplantation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single intuition, double blinded, randomized clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A. Mehrabi, University Hospital Heidelberg
- Investigators
- Arianeb Mehrabi, MD, Principal investigator, Department of General, Visceral and Transplant Surgery, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682627
- Sponsor's protocol ID
- S-318/2017
- Acronym
- PREFEN
- Status last verified
- Sep 2018
- First submitted
- 18 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Golriz M, Sabagh M, Mohammadi S, Ghamarnejad O, Khajeh E, Mieth M, Al-Saeedi M, Diener MK, Mihaljevic AL, Morath C, Zeier M, Kulu Y, Mehrabi A. PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 13;10(10):e032286. doi: 10.1136/bmjopen-2019-032286.
PubMed 33051226
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREventive Effect of FENestration With and Without Clipping on Post-Kidney Transplantation Lymphatic Complications: PREFEN Trial
- ClinicalTrials.gov ID
- NCT03682627
- Acronym / sponsor ID
- PREFEN / S-318/2017
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplantation, Lymphatic complications, preventive fenestration, clipping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Sep 2018 (actual)
- 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.
Post-Kidney Transplantation Lymphatic complications include lymphorrhea and lymphocele, and are some of the most challenging issues after kidney transplantation. The most frequent post-Kidney transplantation complication is accumulation of perirenal fluids, such as urinomas, hematomas, and lymphoceles. Lymphoceles are associated with morbidities such as abdominal discomfort, impaired wound healing, and thrombosis. Lymphoceles may also affect graft function by putting direct pressure on the kidney, or by compressing the ureter or transplant vasculature. The frequency and consequences of post-transplantation lymphoceles make preventive measures highly desirable. Peritoneal fenestration during kidney Transplantation is a simple method for preventing lymphocele formation. Recent studies have evaluated the effectiveness of clipping with metallic clips following fenestration on lymphocele formation and lymph leakage after prostate cancer surgery and laparoscopic retroperitoneal lymph node dissection. However, whether clipping prevents lymphocele formation after kidney transplantation has not been investigated. The aim of the proposed study is to compare the effect of fenestration with and without clipping on incidence of post-kidney transplantation lymphocele and lymphorrhea.
Detailed description
Recent improvements in transplantation techniques, organ matching systems, and modern immunosuppressive regiments have made kidney transplantation a routine operation with acceptable mortality and morbidity rates. Post-kidney transplantation morbidities include vascular and urological complications, and postoperative fluid collections. Perirenal fluid collections, such as urinomas, hematomas, and lymphoceles, are some of most frequent complications following Kidney transplantation, among which post-Kidney transplantation lymphatic collections, are most challenging complications.
The incidence of post-kidney transplantation lymphatic complications is up to 50% and the peak incidence of lymphocele is during the 6th postoperative week (range: 2 weeks to 6 months).
Lymphoceles are usually asymptomatic and identified incidentally by routine ultrasound examination. However lymphoceles may result in morbidities such as abdominal discomfort, impaired wound healing, and thrombosis. Post-kidney transplantation lymphatic complications may also affect graft function by putting pressure on the kidney, or by compressing the ureter or transplant vasculature. The frequency and consequences of post-transplantation lymphoceles make preventive measures highly desirable.
Various preventive methods have been proposed in the literature. Lymphoceles usually originate from unligated lymphatic vessels, therefore precise ligation of donor and recipient lymphatic vessels can reduce lymphocele formation. Compression therapy of the lower limb after kidney transplantation and appropriate immunosuppressive therapy may also reduce lymphocele formation. Some authors have used polymeric sealants/hemostatic biomaterials or povidone-iodine to prevent lymphocele formation. However, the effectiveness and cost-efficiency of these methods has not been conclusively proven. Use of drains in lymphocele prevention has also been previously suggested, but this method remains controversial. Peritoneal fenestration at the time of kidney transplantation is a simple method to prevent lymphocele formation. This method has been widely studied in treatment and prevention of lymphoceles following kidney transplantation. However, to the best of our knowledge, only one randomized controlled trial has been performed to investigate the impact of preventive fenestration in prevention of post kidney transplantation lymphatic complications. This study showed that the prevalence of fluid collections in the fifth postoperative week was significantly higher in the standard group compared to fenestration group. Also, 15.5% of patients in the standard group developed symptomatic lymphoceles requiring treatment during the first postoperative year, versus 3.0% in the fenestration group.
Recent studies have evaluated the effectiveness of extensive clipping using metallic clips following fenestration on lymphocele formation and lymph leakage after prostate cancer surgery and laparoscopic retroperitoneal lymph node dissection. Some surgeons have declared concerns that larger fenestrations increase the risk of hernia. However, risk of closure of the peritoneal fenestration is higher for smaller Windows in the peritoneal cavity. Recently clipping of the edges of peritoneal fenestration was performed in the surgical clinic of the Heidelberg University Hospital to reduce risk of closure of the fenestration after kidney transplantation. However, whether fenestration and clipping prevents lymphocele formation after kidney transplantation has not been investigated.
This clinical Trial is designed to investige the rate of post-kidney transplantation lymphocele and lymphorrhea in two groups of kidney transplantation patients: one with only fenestration and one with fenestration and clipping of the edges. Additionally, graft function and incidence rate of other morbidities will be investigated and analyzed after transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single intuition, double blinded, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| preventive fenestration | Active comparator | Procedure: FenestrationFenestration is performed at the time of kidney transplantation |
| preventive fenestration and clipping | Experimental | Procedure: Fenestration and clippingFenestration and clipping of the edges are performed at the time of kidney transplantation |
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 > 18 years
- Provide written informed consent
- Recipients of KTx from deceased donors
Key exclusion criteria (3 listed)
- Inability to comply with study and/or follow-up procedures
- Recipients of KTx from living donors
- Combined transplantation (e.g. pancreas-kidney transplantation)
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 |
|---|---|---|
| FenestrationA standardized fenestration of the peritoneum will be performed. A 2 cm incision will be made in the peritoneum that is parallel to the skin incision after the transplant procedure. The peritoneal will not be sutured at the edges to keep the fenestration open. No interpositioning of the omentum will be performed. | Procedure or surgery | preventive fenestration |
| Fenestration and clippingA standardized fenestration of the peritoneum will be performed. A 2 cm incision will be made in the peritoneum that is parallel to the skin incision after the transplant procedure. The window edges will be clipped after fenestration using 8 metal clips. | Procedure or surgery | preventive fenestration and clipping |
Primary outcome
Post kidney transplantation lymphocele
Time frame: 6 months
Fluid collection of variable size located near to the transplanted kidney in a non-epithelialized cavity. The possibility that the accumulation of fluid is a hematoma, abscess, and urinoma will be ruled out after aspiration of the fluid.
17 secondary outcomes
Operation time
Time frame: 1 day
Estimated blood loss
Time frame: 1 day
Length of hospital stay
Time frame: 6 months
Postoperative complications
Time frame: 6 months
Mortality
Time frame: 90 days
Post Kidney transplantation fluid collection
Time frame: 6 months
Post Kidney transplantation lymphorrhea
Time frame: 6 months
Lymphocele size
Time frame: 6 months
Lymphocele symptomes
Time frame: 6 months
Lymphocele/lymphorrhea severity grade
Time frame: 6 months
Blood Urea Nitrogen Level
Time frame: 6 months
Plasma uric acid Level
Time frame: 6 months
Serum creatinine level
Time frame: 6 months
Rate of delayed graft function
Time frame: 30 days
Glomerular filtration rate
Time frame: 6 months
Rate of primary non-function grafts
Time frame: 30 days
Retransplantion rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Derived from this study: PubMed 33051226Golriz M, Sabagh M, Mohammadi S, Ghamarnejad O, Khajeh E, Mieth M, Al-Saeedi M, Diener MK, Mihaljevic AL, Morath C, Zeier M, Kulu Y, Mehrabi A. PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial. BMJ Open. 2020 Oct 13;10(10):e032286. doi: 10.1136/bmjopen-2019-032286.
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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.
Arianeb Mehrabi, MD principal investigator
Department of General, Visceral and Transplant Surgery, University Hospital
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 and Fenestration and clipping in people with Kidney Transplantation, run by University Hospital Heidelberg at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Sep 2018. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arianeb Mehrabi, MD (0049 - 6221 - 5636223, arianeb.mehrabi@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post kidney transplantation lymphocele (time frame: 6 months). 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 NCT03682627, 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 24 Sep 2018.