Prevention of Incisional Hernia After Renal Transplantation
1 other identifier
interventional
160
1 country
1
Brief Summary
Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 22, 2024
November 1, 2024
4.3 years
March 9, 2021
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT)
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT) of incisional hernia at 2 years post-transplantation.
24 months
Secondary Outcomes (1)
To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation
3, 6, 12 and 24 months
Other Outcomes (2)
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by the reduction in the incidence of incisional hernia at 2 years post-transplantation measured by radiological diagnosis (CT)
24 months
To determine the incidence of incisional hernia surgery in post-renal transplantation measured by physical examination at 3, 6 and 12 months and by radiological diagnosis (CT) at 24 months
3, 6, 12 and 24 months
Study Arms (2)
ProGrip® Mesh reinforcement
ACTIVE COMPARATOROnce the closure has been completed in 2 muscle-aponeurotic planes with continuous synthetic suture (Monomax® USP 0), the closure will be completed by placing the ProGrip® macroporous polypropylene monofilament mesh in supra-aponeurotic position using the surface with the polylactic acid microgrips, which act as Velcro, in direct contact with the superficial aponeurotic plane constituted by the aponeuroses of the greater oblique muscle and the crescentic line of the anterior rectus abdominis muscle. The polylactic acid microgrips provide immediate fixation, making additional fixation with stitches unnecessary, which makes the technique very easy to use and systematize among the different surgeons of the transplant team. The procedure is completed with the placement of a low caliber round Jackson-Pratt subcutaneous drain (10F) connected to a vacuum system that will be removed on post-transplant day 2 or 3
Monomax® USP 0 2 planes closure
NO INTERVENTIONThe control group will proceed according to standard clinical practice with closure using the technique in 2 muscle-aponeurotic planes with very long-term (3 months) absorbable synthetic continuous suture of poly(4-hydroxybutyrate), monofilament, elastic (Monomax® USP 0) according to the small-bites technique. In order to achieve masking of the participating subject, a small-bore (10F) Jackson-Pratt drain connected to a vacuum system will be placed in the subcutaneous space at the end of the procedure in a manner similar to the intervention group. In both treatment groups, the subcutaneous drain will be removed on post-transplant day 2 or 3.
Interventions
Supra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position
Eligibility Criteria
You may qualify if:
- Candidate for first kidney transplant
You may not qualify if:
- Patient receiving a second or successive renal transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Related Publications (1)
Gomez-Dos-Santos V, Lopez-Plaza JA, Molina-Villar JM, Blazquez-Hernando L, Diez-Nicolas V, Jimenez-Cidre M, Porrero-Guerrero B, Rodriguez-Patron R, Arias-Funez F, Muriel-Garcia A, Fernandez-Cebrian JM, Burgos-Revilla FJ. Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial. Trials. 2023 Aug 14;24(1):528. doi: 10.1186/s13063-023-07545-0.
PMID: 37580782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
VICTORIA GOMEZ
Fundación para la Investigación Biomédica del Hospital Unive
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- For observer masking, the observer (outcomes assessor) will belong to the General Surgery team that is not directly involved with the transplantation procedure and agrees not to verify the assignment in the transplantation surgical protocol. Finally, the masking of the analyst (investigator) is achieved through collaboration with the Clinical Biostatistics Unit in the data analysis of the study (independent analyst) using a pseudo-anonymized database.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Renal Surgery and Transplantation Section
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 12, 2021
Study Start
August 31, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- At the end of the study for 6 months
- Access Criteria
- After approval of an specific ethics commission
All data collected in the project will be recorded and stored in an electronic data capture tool developed for this project under REDCap (Research Electronic Data Capture, Vanderbilt University, TN, USA) that complies with national and international regulatory and legal requirements, including GDPR Regulation (EU) 2016/679. Data generated will be uploaded to provide access to the PI. Data will be shared by the PI only with the research team members. Access data security would be granted and supervised by the Data Protection Officer (DPO). All patient level data will be accessed only in coded and anonymized form. Once the objectives of the project have been achieved, the data used will be deposited in the internal REDCap repository of IRYCIS, which is the Institutional Repository of the Ramón y Cajal Health Research Institute. Access to the internal repository data for other researchers who may be legitimately interested in them will be subject to the approval of an ethics commission.