Clinical trial NCT04794582: Prevention of Incisional Hernia After Renal Transplantation
Official title: Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incisional Hernia
Kidney Transplantation
Postoperative Complications
Keywords: Incisional Hernia
Kidney Transplantation
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2021-03-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Candidate for first kidney transplant

Exclusion Criteria:

* Patient receiving a second or successive renal transplant.

Primary outcomes:
measure: To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT)
timeFrame: 24 months
Secondary outcomes:
measure: To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
measure: 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)
timeFrame: 24 months
measure: 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
timeFrame: 3, 6, 12 and 24 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Fundación para la Investigación Biomédica del Hospital Unive
name: VICTORIA GOMEZ
role: PRINCIPAL_INVESTIGATOR
References: