Incisional HerniaNCT04794582
Prevention of Incisional Hernia After Renal Transplantation
A study testing ProGrip™ Self-Gripping Polyester Mesh in people with Incisional Hernia and Kidney Transplantation, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Kidney Transplantation, Postoperative Complications
- What is being tested?
- ProGrip™ Self-Gripping Polyester Mesh
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for first kidney transplant
Who cannot join
- Patient receiving a second or successive renal transplant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Victoria D Gómez, +34670795972, vgomezd69@gmail.com
Francisco Javier Burgos, +34639155661, burgosrevillajavier@gmail.com
About this study
Official title: Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh
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.
Read the 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.
- Being tested
- ProGrip™ Self-Gripping Polyester Mesh
- Keywords
- Incisional Hernia, Kidney Transplantation
- Medical subject headings
- Incisional Hernia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProGrip™ Self-Gripping Polyester MeshDevice
Supra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position
| Study group | Role | What they receive |
|---|---|---|
| ProGrip® Mesh reinforcement | Active comparator | 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 Receives: Device: ProGrip™ Self-Gripping Polyester Mesh |
| Monomax® USP 0 2 planes closure | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation
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.
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start31 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Victoria Gómez Dos Santos, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Investigators
- VICTORIA GOMEZ, Principal investigator, Fundación para la Investigación Biomédica del Hospital Unive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794582
- Sponsor's protocol ID
- 445/20
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37580782
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh
- ClinicalTrials.gov ID
- NCT04794582
- Acronym / sponsor ID
- 445/20
- Keywords
- Incisional Hernia, Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ProGrip® Mesh reinforcement | Active comparator | Device: ProGrip™ Self-Gripping Polyester MeshOnce 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidate for first kidney transplant
Key exclusion criteria (1 listed)
- Patient receiving a second or successive renal transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProGrip™ Self-Gripping Polyester MeshSupra-aponeurotic placement of ProGrip® macroporous polyester mesh in the supra-aponeurotic position | Device | ProGrip® Mesh reinforcement |
Primary outcome
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.
1 secondary outcome
To determine the safety of mesh reinforcement in laparotomy closure in renal transplantation
Time frame: 3, 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 37580782Gomez-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
VICTORIA GOMEZ principal investigator
Fundación para la Investigación Biomédica del Hospital Unive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProGrip™ Self-Gripping Polyester Mesh in people with Incisional Hernia and Kidney Transplantation, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GOMEZ (+34670795972, vgomezd69@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation measured by radiological diagnosis (CT) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.