Ventral Hernia RepairCOMpACT-BIONCT04597840
Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia
A study testing Incisional hernia repair with reinforcement of biosynthetic mesh and Incisional hernia repair with simple suture or synthetic mesh reinforcement. in people with Ventral Hernia Repair, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Repair
- What is being tested?
- Incisional hernia repair with reinforcement of biosynthetic mesh and Incisional hernia repair with simple suture or synthetic mesh reinforcement.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
All the following inclusion criteria must be fulfilled:
- Age ≥18 years old
- Physical status ASA < 4
- Patient with a mid-line IH
- Patient presenting with an IH without loss of domain
- Surgical indication in elective surgery
- "Potentially contaminated" grade III surgical environment according to the classification of the modified VHWG
- Cure of mid line IH feasible according to the defined standard technical modality (placement of a retromuscular prosthesis)
- No emergency surgical procedure
- Status of social insured or entitled to a social insurance
- Informed and signed consent of the patient after clear and appropriate information
The exclusion criteria are as follows:
- One or multiple incisional hernia out of the midline incision
- Pregnancy, breastfeeding, parturient or childbearing patients without contraception
- Known allergy to tetracyclines;
- Persons protected by law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69310
Guillaume PASSOT, Pr
About this study
Official title: Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair
Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.
Read the detailed description
The current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. However, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. In order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. However, some controversies exist about the clinical benefit of biological meshes in the long term. Reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. Moreover, the financial cost of biological meshes is very high. Recently developed, biosynthetic meshes appear to be a promising option ; Compared to biological meshes, they seem to have several advantages. However, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. In this regard, the COMpACT-BIO study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. This is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.
- Conditions
- Ventral Hernia Repair
- Being tested
- Incisional hernia repair with reinforcement of biosynthetic mesh, Incisional hernia repair with simple suture or synthetic mesh reinforcement.
- Keywords
- ventral hernia repair, contaminated surgical field, infected incisional hernia, biosynthetic mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional hernia repair with reinforcement of biosynthetic meshProcedure or surgery
The biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol.
Incisional hernia repair with simple suture or synthetic mesh reinforcement.Procedure or surgery
Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| biosynthetic mesh group | Experimental | Patient will undergo incisional hernia repair with biosynthetic mesh reinforcement. Based on the discretion of the surgeon, two types of biosynthetic mesh from different brand can be used: the Phasix mesh from BARD or the BioA mesh from GORE. These two biosynthetic meshes are resorbable, which means they are gradually absorbed by the body. Receives: Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh |
| standard of repair group | Other | Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes). Receives: Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incisional hernia recurrence
The rate of incisional hernia recurrence will be evaluated by radiologic imaging.
Measured: 3 years after surgery
Secondary outcomes (9)
Days of hospitalization related to incisional hernia repair
Number of days of hospitalization related to hernia repair-related complications will be reported.
Measured: For 3 years after surgery
Incidence of re-operation related to incisional hernia repair
Incidence of incisional hernia repair-related complications leading to re-operation will be reported.
Measured: For 3 years after surgery
Incidence of wound events
Incidence of incisional hernia repair-related wound complications, such as wound infection will be reported.
Measured: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Incidence of revision surgery or interventional radiologic procedure
Incidence of revision surgery or interventional radiologic procedure related incisional hernia repair-related wound complications will be reported.
Measured: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Rate of early incisional hernia recurrence
The rate of incisional hernia recurrence evaluated by physical examination and then confirmed by radiologic imaging will be reported.
Measured: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Incisional hernia specific quality-of-life assessment
Self reported clinical symptoms before and after incisional hernia repair will be done using a modified version of the Carolina Comfort Scale . Severity of pain and discomfort pre and post repair will be measured during different daily activities (item). Each item is scored 0-5 (0= no symptom ; 5= worst symptom).
Measured: Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Number of healing days
At each clinical examination, the time between surgery and the end of median scar care will be measured.
Measured: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Rate of screening failure
The proportion of patients who did not receive the surgical procedure proposed by the study, and the related reasons of screening failure will be reported.
Measured: 48 months after the start of the study
Assessment of health care consumption related to health care status
The cost / quality ratio will be measured using the consumption of health care and the health status. In one hand, each health care action will be reported (by the patient or the caregiver) and then the total cost relative to the health care will be measured. In another hand, self-reported health status before and after incisional hernia repair will be done using the EQ-5D-5L questionnaire.
Measured: pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start25 May 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (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 Ventral Hernia RepairStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597840
- Sponsor's protocol ID
- 69HCL20_0215
- Acronym
- COMpACT-BIO
- Status last verified
- Jun 2022
- First submitted
- 31 Jul 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Passot G, Margier J, Kefleyesus A, Rousset P, Ortega-Deballon P, Renard Y, Bin S, Villeneuve L. Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation. BMJ Open. 2022 Aug 25;12(8):e061184. doi: 10.1136/bmjopen-2022-061184.
PubMed 36008058
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair
- ClinicalTrials.gov ID
- NCT04597840
- Acronym / sponsor ID
- COMpACT-BIO / 69HCL20_0215
- Conditions
- Ventral Hernia Repair
- Keywords
- ventral hernia repair, contaminated surgical field, infected incisional hernia, biosynthetic mesh
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Oct 2020 (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.
Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.
Detailed description
The current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. However, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. In order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. However, some controversies exist about the clinical benefit of biological meshes in the long term. Reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. Moreover, the financial cost of biological meshes is very high. Recently developed, biosynthetic meshes appear to be a promising option ; Compared to biological meshes, they seem to have several advantages. However, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. In this regard, the COMpACT-BIO study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. This is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biosynthetic mesh group | Experimental | Procedure: Incisional hernia repair with reinforcement of biosynthetic meshPatient will undergo incisional hernia repair with biosynthetic mesh reinforcement. Based on the discretion of the surgeon, two types of biosynthetic mesh from different brand can be used: the Phasix mesh from BARD or the BioA mesh from GORE. These two biosynthetic meshes are resorbable, which means they are gradually absorbed by the body. |
| standard of repair group | Other | Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement.Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Incisional hernia repair with reinforcement of biosynthetic meshThe biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol. | Procedure or surgery | biosynthetic mesh group |
| Incisional hernia repair with simple suture or synthetic mesh reinforcement.Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol. | Procedure or surgery | standard of repair group |
Primary outcome
Rate of incisional hernia recurrence
Time frame: 3 years after surgery
The rate of incisional hernia recurrence will be evaluated by radiologic imaging.
9 secondary outcomes
Days of hospitalization related to incisional hernia repair
Time frame: For 3 years after surgery
Incidence of re-operation related to incisional hernia repair
Time frame: For 3 years after surgery
Incidence of wound events
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Incidence of revision surgery or interventional radiologic procedure
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Rate of early incisional hernia recurrence
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Incisional hernia specific quality-of-life assessment
Time frame: Pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Number of healing days
Time frame: 1 month from surgery date, then 3-, 6- 12-, 24- and 36 months from surgery date
Rate of screening failure
Time frame: 48 months after the start of the study
Assessment of health care consumption related to health care status
Time frame: pre and post-surgery (1 month from surgery date, then 3, 6, 12, 24 and 36 months from surgery date).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 36008058Passot G, Margier J, Kefleyesus A, Rousset P, Ortega-Deballon P, Renard Y, Bin S, Villeneuve L. Slowly absorbable mesh versus standard care in the management of contaminated midline incisional hernia (COMpACT-BIO): a multicentre randomised controlled phase III trial including a health economic evaluation. BMJ Open. 2022 Aug 25;12(8):e061184. doi: 10.1136/bmjopen-2022-061184.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional hernia repair with reinforcement of biosynthetic mesh and Incisional hernia repair with simple suture or synthetic mesh reinforcement. in people with Ventral Hernia Repair, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume PASSOT, Pr (4 78 86 23 71 ext. +33, guillaume.passot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of incisional hernia recurrence (time frame: 3 years after surgery). 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 NCT04597840, 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 5 Jul 2022.