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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Germany

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.

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 groups in NCT03682627
Study groupRoleWhat they receive
preventive fenestrationActive comparatorFenestration is performed at the time of kidney transplantation
Receives: Procedure: Fenestration
preventive fenestration and clippingExperimentalFenestration 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.

  1. 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)
  1. Operation time

    From skin incision to skin closure

    Measured: 1 day

  2. Estimated blood loss

    Blood loss during operation from skin incision to skin closure (mL)

    Measured: 1 day

  3. Length of hospital stay

    From the time of the operation to time of discharge

    Measured: 6 months

  4. Postoperative complications

    Postoperative complications will be reported and classified according to the Clavien-Dindo classification.

    Measured: 6 months

  5. Mortality

    Death due to any cause.

    Measured: 90 days

  6. 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

  7. 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

  8. Lymphocele size

    Lymphocele diameter and volume will be recorded by ultrasound examination in mL.

    Measured: 6 months

  9. Lymphocele symptomes

    Measured: 6 months

  10. 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

  11. Blood Urea Nitrogen Level

    Blood Urea Nitrogen Level (mg/dL)

    Measured: 6 months

  12. Plasma uric acid Level

    Plasma uric acid Level (mg/dL)

    Measured: 6 months

  13. Serum creatinine level

    Serum creatinine level (mg/dL)

    Measured: 6 months

  14. 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

  15. 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

  16. Rate of primary non-function grafts

    number of recipients whose grafts never functions after transplantation

    Measured: 30 days

  17. 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.

  1. First posted24 Sep 2018
  2. Study startOct 2018 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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

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.

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