Preventive Fenestration With and Without Clipping in Kidney Transplantation

NCT03682627 | Unknown

• 1 other identifier: S-318/2017
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

kidney transplantation; Lymphatic complications; preventive fenestration; clipping

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (17)

• Operation time

  1 day

• Estimated blood loss

  1 day

• Length of hospital stay

  6 months

• Postoperative complications

  6 months

• Mortality

  90 days

Study Arms (2)

preventive fenestration

ACTIVE COMPARATOR

Fenestration is performed at the time of kidney transplantation

Procedure: Fenestration

preventive fenestration and clipping

EXPERIMENTAL

Fenestration and clipping of the edges are performed at the time of kidney transplantation

Procedure: Fenestration and clipping

Interventions

Fenestration PROCEDURE

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.

preventive fenestration

Fenestration and clipping PROCEDURE

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.

preventive fenestration and clipping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (1)

• 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.

  PMID: 33051226 DERIVED

MeSH Terms

Interventions

Fenestration, Labyrinth

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Arianeb Mehrabi, MD

  Department of General, Visceral and Transplant Surgery, University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arianeb Mehrabi, MD

CONTACT

0049 - 6221 - 5636223; arianeb.mehrabi@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Model Details: single intuition, double blinded, randomized clinical trial.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 24, 2018
• Study Start: October 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

DE (1)