Prevention of Incisional Hernia After Renal Transplantation

NCT ID: NCT04794582

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

As defined by the European Hernia Society, eventration or incisional hernia is any defect in the abdominal wall with or without an associated bulge in the area of a surgical scar that is noticeable or palpable by physical examination or imaging tests. Incisional hernias after abdominal organ transplantation are of special interest since transplant recipients undergo immunosuppressive treatment that may increase the risk of developing incisional hernias due to their impact on the healing process. It is estimated that the incidence of incisional hernia after renal transplantation ranges from 1.6 to 18% and increases to 1.7-32.4% and 13.0-34.8% after liver and pancreatic transplantation respectively. Incisional hernias are a major source of morbidity and most require surgical repair at some point in time. Regarding patient-related factors, female sex and obesity have been identified as potential risk factors. In the case of immunosuppressive medication, nucleotide synthesis inhibitors such as mycophenolate and m-TOR inhibitors such as sirolimus have been associated with a higher incidence of incisional hernia. With regard to factors specifically related to the surgical wound, surgical wound infection and type of incision have been identified as risk factors. In 2018 Simson et al published a systematic review of the existing literature that highlights the limited scientific evidence that is primarily made up of case series review. We conducted a retrospective observational study that identified an incidence of 12.5% of incisional hernia on physical examination, which increase to 29.8% on radiological examination (CT) with a median time to diagnosis of 17.1 months (2.5 - 23.9). An additional 17.5% of muscle atrophy was observed.

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 a randomized clinical trial is proposed.

In accordance with the extensive experience and recommendations of the Abdominal Wall Section of the General and Digestive Surgery Department of our hospital, we intend to carry out a randomized clinical trial for the prophylactic use of Medtronic ProGrip™ Self-Gripping Polyester Mesh mesh reinforcement in supra-aponeurotic position. This mesh features polylactic acid (PLA) microgrips that act as Velcro, providing immediate, strong and uniform fixation, weighing 82 g/m2 before PLA resorption and 41 g/m2 after resorption (low density). The use of this mesh combines the effectiveness demonstrated by the macropore meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation for which it is equipped with the so-called absorbable microgrips of polylactic acid that adhere quickly and easily to the underlying tissue and safety. This mesh has proven its usefulness and safety for the prophylaxis of eventration in patients with other types of lateral incisions.

Patients in ProGrip group will be treated with self-gripping polyester and Polylactic acid meshes providing a sutureless fixation.

In the control group, closure will be performed according to standard clinical practice 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.

Study participation will start at signature of informed consent and each patient will be assessed before surgery. A close follow-up will be performed at 3, 6, 12 months (clinical visit, physical examination, laboratory tests, adverse effects), and final evaluation at 24 months (clinical visit, physical examination, laboratory tests, adverse effects and radiological examination -CT-) after surgery, which will end the participation to the study.

160 adult (>18 years) recipients of a first kidney transplantation divided in 2 groups will be included in the study. Allocation by the obesity variable, which is a determinant risk factor in the response to the intervention, will be carried out using permuted blocks of variable size in each stratum.

Conditions

Incisional Hernia; Kidney Transplantation; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ProGrip™ Self-Gripping Polyester Mesh

Intervention Type: DEVICE

Supra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ProGrip™ Self-Gripping Polyester Mesh

Supra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Candidate for first kidney transplant

Exclusion Criteria

• Patient receiving a second or successive renal transplant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Victoria Gómez Dos Santos

Head of Renal Surgery and Transplantation Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

VICTORIA GOMEZ

Role: PRINCIPAL_INVESTIGATOR

Fundación para la Investigación Biomédica del Hospital Unive

Locations

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

GOMEZ

Role: CONTACT

vgomezd69@gmail.com

+34670795972

BURGOS

Role: CONTACT

burgosrevillajavier@gmail.com

+34639155661

Facility Contacts

Victoria D Gómez

Role: primary

vgomezd69@gmail.com

+34670795972

Francisco Javier Burgos

Role: backup

burgosrevillajavier@gmail.com

+34639155661

References

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.

Reference Type: DERIVED

PMID: 37580782 (View on PubMed)

Other Identifiers

445/20

Identifier Type: -

Identifier Source: org_study_id