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Trial record 4 of 2150 for:    Kidney Transplantation

Preventive Fenestration With and Without Clipping in Kidney Transplantation (PREFEN)

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ClinicalTrials.gov Identifier: NCT03682627
Recruitment Status : Not yet recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. A. Mehrabi, University Hospital Heidelberg

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Procedure: Fenestration Procedure: Fenestration and clipping Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single intuition, double blinded, randomized clinical trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PREventive Effect of FENestration With and Without Clipping on Post-Kidney Transplantation Lymphatic Complications: PREFEN Trial
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: preventive fenestration
Fenestration is performed at the time of kidney transplantation
Procedure: Fenestration
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.

Experimental: preventive fenestration and clipping
Fenestration and clipping of the edges are performed at the time of kidney transplantation
Procedure: Fenestration and clipping
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Operation time [ Time Frame: 1 day ]
    From skin incision to skin closure

  2. Estimated blood loss [ Time Frame: 1 day ]
    Blood loss during operation from skin incision to skin closure (mL)

  3. Length of hospital stay [ Time Frame: 6 months ]
    From the time of the operation to time of discharge

  4. Postoperative complications [ Time Frame: 6 months ]
    Postoperative complications will be reported and classified according to the Clavien-Dindo classification.

  5. Mortality [ Time Frame: 90 days ]
    Death due to any cause.

  6. Post Kidney transplantation fluid collection [ Time Frame: 6 months ]
    Fluid accumulation near to the transplanted kidney will be diagnosed by ultrasound as routine of the Heidelberg

  7. Post Kidney transplantation lymphorrhea [ Time Frame: 6 months ]
    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

  8. Lymphocele size [ Time Frame: 6 months ]
    Lymphocele diameter and volume will be recorded by ultrasound examination in mL.

  9. Lymphocele symptomes [ Time Frame: 6 months ]
  10. Lymphocele/lymphorrhea severity grade [ Time Frame: 6 months ]
    Severity of lymphocele/lymphorrhea will be graded based on the applied management strategy (Grade A: Observation, Grade B: Non-surgical intervention, Grade C: Surgery).

  11. Blood Urea Nitrogen Level [ Time Frame: 6 months ]
    Blood Urea Nitrogen Level (mg/dL)

  12. Plasma uric acid Level [ Time Frame: 6 months ]
    Plasma uric acid Level (mg/dL)

  13. Serum creatinine level [ Time Frame: 6 months ]
    Serum creatinine level (mg/dL)

  14. Rate of delayed graft function [ Time Frame: 30 days ]
    Is defined as the need for one or more hemodialysis treatments following transplantation prior to the onset of graft function.

  15. Glomerular filtration rate [ Time Frame: 6 months ]
    GFR (mL/min/1.73 m2) calculated with "175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female)" Formula

  16. Rate of primary non-function grafts [ Time Frame: 30 days ]
    number of recipients whose grafts never functions after transplantation

  17. Retransplantion rate [ Time Frame: 6 months ]
    Rate of retransplantation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Provide written informed consent
  • Recipients of KTx from deceased donors

Exclusion Criteria:

  • Inability to comply with study and/or follow-up procedures
  • Recipients of KTx from living donors
  • Combined transplantation (e.g. pancreas-kidney transplantation)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682627


Contacts
Contact: Arianeb Mehrabi, MD 0049 - 6221 - 5636223 arianeb.mehrabi@med.uni-heidelberg.de

Locations
Germany
Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Arianeb Mehrabi, MD Department of General, Visceral and Transplant Surgery, University Hospital

Responsible Party: Dr. A. Mehrabi, Professor Dr. med., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03682627     History of Changes
Other Study ID Numbers: S-318/2017
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. A. Mehrabi, University Hospital Heidelberg:
kidney transplantation
Lymphatic complications
preventive fenestration
clipping