Incisional Hernia/Prevention and ControlPROMETHEUSNCT07744230
Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study.
An observational study of Incisional Hernia/Prevention and Control, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
A multicenter prospective, consecutive case series study, on the use of a bio-absorbable mesh for prevention of incisional hernia, in high risk patients, after orthotopic liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia/Prevention and Control
- What is being tested?
- mesh
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2025to 30 May 2029
- Phase
- Observational
- 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
Study population: Patients undergoing liver transplantation in 5 centers in Italy
Who may be able to join
- Have at least 3 of the following pre transplant risk factors for IH (definition of high Risk Patients):
- Age >60
- Sex M
- Obesity (HR 1.74, 1.04 to 2.91) (16) (BMI equal to or higher than 30 kg/m², according WHO definition)
- Smoker (OR 3.93, 1.82 to 8.49) (14). An adult who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day, according WHO definition.
- Diabetes (OR 6.68, 2.02 to 22.0) (14) as defined by Centers of Disease Control and Prevention):
Show all 12Show fewer
- Result A1C Test Fasting Blood Sugar Test Glucose Tolerance Test Random Blood Sugar Test Diabetes 6.5% or above 126 mg/dL or above 200 mg/dL or above 200 mg/dL or above
- IRC according KDIGO definition: "CKD is defined as abnormalities of kidney structure or function, present for >3 months, with implications for health," and requires one of two criteria documented or inferred for >3 months: either GFR <60 ml/min/1.73 m2 or markers of kidney damage, including albuminuria.
- MELD > 22 (16)
- COPD (HR 2.35, 1.44 to 3.83) (16): previous diagnosis of emphysema, chronic bronchitis, and chronic obstructive asthma. In pulmonary function testing, a postbronchodilator FEV1/FVC ratio of <0.70 is commonly considered diagnostic for COPD according The Global Initiative for Chronic Obstructive Lung Disease (GOLD) system.
- Moderate/Large ascites at time of transplant. The International Ascites Club classifies the severity classification of ascites as follows: moderate ascites (grade 2): moderate abdominal distention, large ascites (grade 3): marked abdominal distention.
- Sarcopenia (if diagnosed with CT-scan or RM). The study of the muscular compartment at the level of the third lumbar vertebra (L3) by CT is the gold standard technique in the assessment of sarcopenia. (10) The sum of the areas of psoas, erector spinae, multifidus, quadratus lomborum, rectus of the abdomen, transverse and internal and external obliques are divided by the squared height of the patient and define the skeletal muscle index: SMI (Skeletal Muscle Index) = SMA (Skeletal Muscle Area) (cm²) / height (m²). Sarcopenia is defined by cut-off values below 41,6 cm²/m² for men and 32 cm²/m² for women.
Who cannot join
- retransplant, previous upper quadrants laparotomies, previous incisional hernia repair, umbilical hernia > 2cm in diameter, pre-Tx steroids treatment or immunosuppression, patient's rejection to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study. A Multicenter Prospective, Consecutive Case Series Study, on the Use of a Bio-absorbable Mesh for Prevention of Incisional Hernia, in High Risk Patients, After Orthotopic Liver Transplantation.
A multicenter prospective, consecutive case series study, on the use of a bio-absorbable mesh for prevention of incisional hernia, in high risk patients, after orthotopic liver transplantation.
Read the detailed description
STUDY DESIGN Multicenter, prospective, consecutive case series study.
OBJECTIVE The main purpose of the study is to determine whether a bio-absorbable mesh is effective and safe in the prevention of incisional hernia in high risk patients undergoing LT.
Primary endpoint:
- To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.
Secondary endpoint:
- Incidence of IH in different type of incision subgroups
- Incidence of surgical site occurrences
- Surgical site infection
- Seroma
- Evisceration (abdominal dehiscence)
- Mesh complications
- Incidence of general complications
- Incidence of IH in different subset of patients undergoing immunosuppressants (steroids, mTORi)
MATERIALS \& METHODS
- multicenter prospective, consecutive case series study: conventional closure technique (according to each center policy) + bio-absorbable mesh placed in an onlay position, with two-year-follow-up.
PATIENTS ENROLLMENT From the protocol start date all the transplant candidates that meet the inclusion criteria will be enrolled at time of LT by any of the surgeons who belongs to the centers involved in this trial, and an informed consent will be obtained. During the one year enrolling period we aim to include 100 consecutive patients in the study.
DURATION OF SUBJECT PARTICIPATION AND DURATION OF STUDY Subjects will be on study for 24 months. Treatment: day 0 Follow-up: 8 days, 30 days, 3, 6, 12, 18, 24 months The total duration of the study is expected to be 3 years. One year for subjects recruitment and 24 months for final subjects follow-up.
SURGICAL PROCEDURES The technique used for surgical incision and for abdominal wall closure will follow each participating center policy. A slowly absorbable material will be used for closure by all centers.
After conventional closure a bio-absorbable mesh will be placed in a onlay position (PHASIX - C. R. Bard, Inc/Davol Inc, Warwick, RI). The above mentioned meshes are currently available in the participating centers.
The surgeons will be specifically trained in using a prophylactic onlay mesh. An overlapping of 3 cm must be obtained on every side of surgical incision. Fixation methods allowed: interrupted long- term absorbable suture. Subcutaneous and skin closure following center practice. The operating surgeon can decide for the placement of a subcutaneous drain if necessary.
PATIENT FOLLOW-UP An intention to treat analysis is planned. Patient follow up will be carried out in the outpatient clinic at 30 DAYS, 3, 6, 12, 18 and 24 months by any surgeon involved in the trial.
- Conditions
- Incisional Hernia/Prevention and Control
- Being tested
- mesh
- Keywords
- liver transplantation, incisional hernia, prevention, mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meshProcedure or surgery
The technique used for surgical incision and for abdominal wall closure will follow each participating center policy. A slowly absorbable material will be used for closure by all centers.
After conventional closure a bio-absorbable mesh will be placed in a onlay position (PHASIX - C. R. Bard, Inc/Davol Inc, Warwick, RI). The above mentioned meshes are currently available in the participating centers.
The surgeons will be specifically trained in using a prophylactic onlay mesh. An overlapping of 3 cm must be obtained on every side of surgical incision. Fixation methods allowed: interrupted long- term absorbable suture. Subcutaneous and skin closure following center practice. The operating surgeon can decide for the placement of a subcutaneous drain if necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernias after LT
To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.
Measured: 2 years follow up
Secondary outcomes (1)
Incidence of IH in different type of incisions, Incidence od SSO
- Incidence of IH in different type of incision subgroups
- Incidence of surgical site occurrences
- Surgical site infection
- Seroma
- Evisceration (abdominal dehiscence)
- Mesh complications
- Incidence of general complications
- Incidence of IH in different subset of patients undergoing immunosuppressants (steroids, mTORi)
Measured: 2 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 May 2025
- Primary completion30 May 2029 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia/Prevention and ControlStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Anselmo, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744230
- Sponsor's protocol ID
- REGISTRO SPERIMENTAZIONI 284.2
- Acronym
- PROMETHEUS
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prometheus: Prophylactic Mesh After OLtx for Hernia Reduction Study. A Multicenter Prospective, Consecutive Case Series Study, on the Use of a Bio-absorbable Mesh for Prevention of Incisional Hernia, in High Risk Patients, After Orthotopic Liver Transplantation.
- ClinicalTrials.gov ID
- NCT07744230
- Acronym / sponsor ID
- PROMETHEUS / REGISTRO SPERIMENTAZIONI 284.2
- Conditions
- Incisional Hernia/Prevention and Control
- Keywords
- liver transplantation, incisional hernia, prevention, mesh
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
A multicenter prospective, consecutive case series study, on the use of a bio-absorbable mesh for prevention of incisional hernia, in high risk patients, after orthotopic liver transplantation.
Detailed description
STUDY DESIGN Multicenter, prospective, consecutive case series study.
OBJECTIVE The main purpose of the study is to determine whether a bio-absorbable mesh is effective and safe in the prevention of incisional hernia in high risk patients undergoing LT.
Primary endpoint:
- To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.
Secondary endpoint:
- Incidence of IH in different type of incision subgroups
- Incidence of surgical site occurrences
- Surgical site infection
- Seroma
- Evisceration (abdominal dehiscence)
- Mesh complications
- Incidence of general complications
- Incidence of IH in different subset of patients undergoing immunosuppressants (steroids, mTORi)
MATERIALS \& METHODS
- multicenter prospective, consecutive case series study: conventional closure technique (according to each center policy) + bio-absorbable mesh placed in an onlay position, with two-year-follow-up.
PATIENTS ENROLLMENT From the protocol start date all the transplant candidates that meet the inclusion criteria will be enrolled at time of LT by any of the surgeons who belongs to the centers involved in this trial, and an informed consent will be obtained. During the one year enrolling period we aim to include 100 consecutive patients in the study.
DURATION OF SUBJECT PARTICIPATION AND DURATION OF STUDY Subjects will be on study for 24 months. Treatment: day 0 Follow-up: 8 days, 30 days, 3, 6, 12, 18, 24 months The total duration of the study is expected to be 3 years. One year for subjects recruitment and 24 months for final subjects follow-up.
SURGICAL PROCEDURES The technique used for surgical incision and for abdominal wall closure will follow each participating center policy. A slowly absorbable material will be used for closure by all centers.
After conventional closure a bio-absorbable mesh will be placed in a onlay position (PHASIX - C. R. Bard, Inc/Davol Inc, Warwick, RI). The above mentioned meshes are currently available in the participating centers.
The surgeons will be specifically trained in using a prophylactic onlay mesh. An overlapping of 3 cm must be obtained on every side of surgical incision. Fixation methods allowed: interrupted long- term absorbable suture. Subcutaneous and skin closure following center practice. The operating surgeon can decide for the placement of a subcutaneous drain if necessary.
PATIENT FOLLOW-UP An intention to treat analysis is planned. Patient follow up will be carried out in the outpatient clinic at 30 DAYS, 3, 6, 12, 18 and 24 months by any surgeon involved in the trial.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver transplantation in 5 centers in Italy
Key inclusion criteria (12 listed)
- Have at least 3 of the following pre transplant risk factors for IH (definition of high Risk Patients):
- Result A1C Test Fasting Blood Sugar Test Glucose Tolerance Test Random Blood Sugar Test Diabetes 6.5% or above 126 mg/dL or above 200 mg/dL or above 200 mg/dL or above
- IRC according KDIGO definition: "CKD is defined as abnormalities of kidney structure or function, present for >3 months, with implications for health," and requires one of two criteria documented or inferred for >3 months: either GFR <60 ml/min/1.73 m2 or markers of kidney damage, including albuminuria.
- MELD > 22 (16)
- COPD (HR 2.35, 1.44 to 3.83) (16): previous diagnosis of emphysema, chronic bronchitis, and chronic obstructive asthma. In pulmonary function testing, a postbronchodilator FEV1/FVC ratio of <0.70 is commonly considered diagnostic for COPD according The Global Initiative for Chronic Obstructive Lung Disease (GOLD) system.
Key exclusion criteria (1 listed)
- retransplant, previous upper quadrants laparotomies, previous incisional hernia repair, umbilical hernia > 2cm in diameter, pre-Tx steroids treatment or immunosuppression, patient's rejection to participate.
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 |
|---|---|---|
| meshThe technique used for surgical incision and for abdominal wall closure will follow each participating center policy. A slowly absorbable material will be used for closure by all centers. After conventional closure a bio-absorbable mesh will be placed in a onlay position (PHASIX - C. R. Bard, Inc/Davol Inc, Warwick, RI). The above mentioned meshes are currently available in the participating centers. The surgeons will be specifically trained in using a prophylactic onlay mesh. An overlapping of 3 cm must be obtained on every side of surgical incision. Fixation methods allowed: interrupted long- term absorbable suture. Subcutaneous and skin closure following center practice. The operating surgeon can decide for the placement of a subcutaneous drain if necessary. | Procedure or surgery | – |
Primary outcome
Incidence of incisional hernias after LT
Time frame: 2 years follow up
To evaluate the incidence of incisional hernias after LT in a consecutive series of patients that meet the inclusion criteria after conventional abdominal wall closure plus placement of a bio-absorbable mesh in an onlay position, at two years of follow-up.
1 secondary outcome
Incidence of IH in different type of incisions, Incidence od SSO
Time frame: 2 years follow up
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 4 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Incisional Hernia/Prevention and Control
Not yet recruiting
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
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Active, not recruitingPhase 2/3
Small Bites Vs Large Bites Abdominal Midline Incisional Closure
Suture Techniques, Wound Closure Techniques
Active, not recruiting
Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
Incisional Hernia, Emergency Laparotomy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia/Prevention and Control, run by University of Rome Tor Vergata at 1 site in Italy.
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 12 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: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernias after LT (time frame: 2 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.