Clinical trial NCT03682627: Preventive Fenestration With and Without Clipping in Kidney Transplantation
Official title: PREventive Effect of FENestration With and Without Clipping on Post-Kidney Transplantation Lymphatic Complications: PREFEN Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Keywords: kidney transplantation
Lymphatic complications
preventive fenestration
clipping
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single intuition, double blinded, randomized clinical trial.
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Post kidney transplantation lymphocele
timeFrame: 6 months
Secondary outcomes:
measure: Operation time
timeFrame: 1 day
measure: Estimated blood loss
timeFrame: 1 day
measure: Length of hospital stay
timeFrame: 6 months
measure: Postoperative complications
timeFrame: 6 months
measure: Mortality
timeFrame: 90 days
measure: Post Kidney transplantation fluid collection
timeFrame: 6 months
measure: Post Kidney transplantation lymphorrhea
timeFrame: 6 months
measure: Lymphocele size
timeFrame: 6 months
measure: Lymphocele symptomes
timeFrame: 6 months
measure: Lymphocele/lymphorrhea severity grade
timeFrame: 6 months
measure: Blood Urea Nitrogen Level
timeFrame: 6 months
measure: Plasma uric acid Level
timeFrame: 6 months
measure: Serum creatinine level
timeFrame: 6 months
measure: Rate of delayed graft function
timeFrame: 30 days
measure: Glomerular filtration rate
timeFrame: 6 months
measure: Rate of primary non-function grafts
timeFrame: 30 days
measure: Retransplantion rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of General, Visceral and Transplant Surgery, University Hospital
name: Arianeb Mehrabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.