Prevention of Incisional Hernia After Renal Transplantation
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ClinicalTrials.gov Identifier: NCT04794582 |
Recruitment Status :
Recruiting
First Posted : March 12, 2021
Last Update Posted : November 29, 2023
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Condition or disease | Intervention/treatment | Phase |
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Incisional Hernia Kidney Transplantation Postoperative Complications | Device: ProGrip™ Self-Gripping Polyester Mesh | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Blinded parallel randomized clinical trial. A stratified allocation by the variable obesity will be performed using permuted blocks of variable size in each stratum. To guarantee the concealment of the randomization sequence, the randomization codes will be kept in opaque envelopes with correlative numerical identification that will be opened once it has been verified that the patient meets the inclusion criteria and has signed the informed consent form. |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Prevention |
Official Title: | Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh |
Actual Study Start Date : | August 31, 2022 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
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Active Comparator: ProGrip® Mesh reinforcement
Once 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
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Device: ProGrip™ Self-Gripping Polyester Mesh
Supra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position |
No Intervention: Monomax® USP 0 2 planes closure
The 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.
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- To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT) [ Time Frame: 24 months ]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.
- To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation [ Time Frame: 3, 6, 12 and 24 months ]To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation measured by determining the incidence of surgical wound complications: number of seromas, number of surgical wound infections, incidence and severity of acute and chronic pain, and need for mesh removal.
- 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) [ Time Frame: 24 months ]Reduction in the incidence of incisional hernia at 2 years post-transplantation.
- 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 [ Time Frame: 3, 6, 12 and 24 months ]To determine the incidence of incisional hernia surgery in post-renal transplantation.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Candidate for first kidney transplant
Exclusion Criteria:
- Patient receiving a second or successive renal transplant.
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): NCT04794582
Contact: GOMEZ | +34670795972 | vgomezd69@gmail.com | |
Contact: BURGOS | +34639155661 | burgosrevillajavier@gmail.com |
Spain | |
Hospital Universitario Ramón y Cajal | Recruiting |
Madrid, Spain, 28034 | |
Contact: Victoria D Gómez +34670795972 vgomezd69@gmail.com | |
Contact: Francisco Javier Burgos +34639155661 burgosrevillajavier@gmail.com | |
Sub-Investigator: Jose Manuel Molina | |
Sub-Investigator: Jose María Cebrian |
Principal Investigator: | VICTORIA GOMEZ | Fundación para la Investigación Biomédica del Hospital Unive |
Responsible Party: | Victoria Gómez Dos Santos, Head of Renal Surgery and Transplantation Section, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
ClinicalTrials.gov Identifier: | NCT04794582 |
Other Study ID Numbers: |
445/20 |
First Posted: | March 12, 2021 Key Record Dates |
Last Update Posted: | November 29, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | At the end of the study for 6 months |
Access Criteria: | After approval of an specific ethics commission |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Incisional Hernia Kidney Transplantation |
Hernia Postoperative Complications Incisional Hernia Pathological Conditions, Anatomical Pathologic Processes |