Incisional HerniaPhase 3INCISOXNCT06499324
Surgery with Botulinum Toxin a for Incisional Hernia
A Phase 3 study testing BTA group in people with Incisional Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
After laparotomy, treating large incisional hernias (width >= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- BTA group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2025to 4 Mar 2029
- Phase
- Phase 3
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 79 years;
- BMI < 35 kg/m²;
- Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width >= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3);
- IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) < 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion;
- Written informed consent;
- Scheduled surgery for an open IH repair;
- For female of childbearing potential: using highly effective contraception.
Who cannot join
- Other types of IH (lateral, groin, para-stomal, portsite);
- VHWG grades 3 or 4 for the risk of surgical site infection;
- Ongoing skin infection or inflammation at the IH site or at the BTA injection site;
- Planned IH repair with slowly absorbable mesh;
- IH with loss of domain (volumetric ratio > 25%);
- Emergency IH surgery;
Show all 20Show fewer
- ASA score > 3;
- Pregnancy or breastfeeding;
- Ongoing treatment with aminoglycosides;
- Severe hemostasis disorder or non-weaning treatment with curative dose anticoagulant;
- Active tobacco use (or cessation inferior to 3 months);
- Use of another investigational product within 6 months or 5 half-lives (whichever is longer), or currently participating in a prospective study with an investigational product, whether it concerns an experimental drug or a medical device;
- Patient not covered by social insurance;
- Patient under legal guardianship;
- Hypersensitivity to the active substance (Clostridium Botulinum neurotoxin type A) or to any of the excipients (Human albumin, sucrose);
- Generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome, peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy), facial nerve disorders, underlying neurological disorders) and history of dysphagia and aspiration);
- Patient with ongoing treatment with medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g. tubocurarine-type muscle relaxants that weaken the muscles;
- Patient with severe and uncontrolled cardiovascular diseases;
- Patient has received BTA within 12 weeks;
- Patients with a history of seizures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
David Moszkowicz
Colombes, France
David Moszkowicz, Pr, 01 47 60 63 84, david.moszkowicz@aphp.fr
About this study
Official title: Surgical Treatment of Large Incisional Hernia with Botulinum Toxin a Injection: a Double-blind Randomized Controlled Trial
After laparotomy, treating large incisional hernias (width >= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence. High rates of severe postoperative morbidity, up to 50%, are reported, linked to dissection extent, increased muscular tension, and abdominal pressure. Reconstructing normal anatomy by bringing muscles together may be impossible, leading to the use of complex procedures like component separation techniques (CST), involving large aponeurotomy for muscle relaxation. Intramuscular injection of botulinum toxin A (BTA) induces reversible flaccid paralysis, with potential benefits in hernia closure, known as "chemical CST." Retrospective studies suggest reduced muscle retraction and facilitated closure without specific morbidity. Prehabilitation with BTA aims to reduce surgical morbidity compared to repair and CST. The prospective evaluation of BTA's clinical benefits, including reduced postoperative morbidity, pain, successful abdominal closure, and decreased IH recurrence risk, is lacking. A prospective randomized double-blind placebo-controlled trial is proposed to demonstrate BTA's efficacy. The hypothesis is that BTA injection before IH repair is more effective than a placebo in reducing postoperative morbimortality. Secondary expectations include a significant reduction in complete closure of the abdominal wall without CST.
Read the detailed description
Almost 20% of patients will develop an incisional hernia (IH) after laparotomy. Each year in France, around 30,000 patients undergo IH repair with mesh [PMSI, 2017]. The treatment of large IH (width>=10cm) is difficult due to the progressive retraction of the lateral abdominal muscles associated with the separation of the rectus muscles. The IH width is a major risk factor of failure of the repair and recurrence. Furthermore, high rates of severe postoperative morbidity, up to 50%, have been reported and related to the extent of dissection and increase of muscular tension and abdominal pressure. Thus, bringing the muscles together to reconstruct the normal anatomy may be impossible and lead the surgeon to use complex and morbid technical procedures, such as component separation techniques (CST), consisting in large aponeurotomy for relaxation of the lateral muscles. The intramuscular injection of botulinum toxin A (BTA) makes it possible to obtain a reversible flaccid paralysis of the striated muscle fibers and its advantage has been demonstrated for the treatment of neurological spasticity. Its use to obtain a relaxation of the lateral muscles of the abdomen, so-called "chemical CST", reduce their retraction and facilitate hernia closure, as studied in retrospective studies, without specific morbidity. In particular, prehabilitation with BTA injection, is supposed to reduce surgical morbidity in comparison with surgical repair and CST. The expected clinical benefit, in terms of reduction of postoperative morbidity and pain, successful closure of the abdomen, and reduction of the risk of recurrence of the IH, has never been evaluated prospectively. Thus, a prospective randomized double-blind placebo-controlled trial would be the best method to demonstrate the benefit of BTA injection. The investigators hypothesize that BTA injection in the lateral muscles before IH repair is more effective than placebo injection in reducing postoperative morbimortality. Secondarily, the investigators expect that BTA injection is associated with a significant reduction of complete closure of the abdominal wall without CST.
- Conditions
- Incisional Hernia
- Being tested
- BTA group, Placebo group
- Keywords
- Incisional Hernia, Botulinum toxin A, Incisional Hernia repair, Laparatomy
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTA groupDrug
It consists of a blind injection of 288 IU (/144mL) of BTA (XEOMIN®) into the lateral muscles (18 injection sites, 16UI/8mL/injection site), 4 to 6 weeks before the treatment of a large anterior IH (width ≥ 10 cm) with open non absorbable mesh repair. The injection of BTA (XEOMIN®) will be done during an outpatient hospitalization, in each of the 3 lateral muscles of the abdomen on each side. To do this in the BTA group, 3 vials of 100 equivalent IU of BTA (XEOMIN® 100U), diluted to 2 IU/mL with 0.9% saline will be distributed in 3 syringes of 50 mL equipped with a 21G needle. A total of 72 mL of BTA solution (144 IU) will be injected on each side, at 3 injection points between the costal rim and iliac crest, under ultrasound control.
Placebo groupDrug
It consists of a blind injection of placebo of BTA (XEOMIN® 100U matching placebo) into the lateral muscles (18 injection sites, 8mL/injection site), 4 to 6 weeks before the treatment of a large IH (width >= 10 cm) with open non absorbable mesh repair. The injection of placebo of BTA (XEOMIN® 100U matching placebo) will be done during an outpatient hospitalization, in each of the 3 lateral muscles of the abdomen on each side. To do this in the control group, 3 vials of placebo of BTA (XEOMIN® 100U matching placebo), diluted with 0.9% saline will be distributed in 3 syringes of 50 mL equipped with a 21G needle. A total of 72 mL of placebo of BTA solution will be injected on each side, at 3 injection points between the costal rim and iliac crest, under ultrasound control.
| Study group | Role | What they receive |
|---|---|---|
| BTA group | Experimental | This arm corresponds to patients presenting with midline anterior primary or recurrent IH (subxiphoidal to suprapubic) of width >= 10 cm, without loss of domain, scheduled for IH repair with mesh.
Patients will be injected with 288 IU of BTA (XEOMIN® 100U) into the lateral muscles (18 injection sites, 16UI/8mL/injection site), 4 to 6 weeks before the treatment of the IH. Receives: Drug: BTA group |
| Placebo group | Placebo comparator | This arm corresponds to patients presenting with midline anterior primary or recurrent IH (subxiphoidal to suprapubic) of width >= 10 cm, without loss of domain, scheduled for IH repair with mesh.
Patients will be injected with placebo of BTA (XEOMIN® 100U matching placebo) into the lateral muscles (18 injection sites, 8mL/injection site), 4 to 6 weeks before the treatment of the IH. Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the efficacy of preoperative BTA injection in the lateral abdominal wall muscles reduces the rate of postoperative morbimortality after large IH (width >= 10cm) repair with mesh, compared with placebo injection.
Occurrence of Clavien-Dindo classification grade II or higher post-operative complication
Measured: During the 90-day postoperative period
Secondary outcomes (12)
Assessment of the impact of preoperative BTA injection on length of stay.
Length of hospital stay in days
Measured: From surgery until hospital discharge, average 5 days
Assessment of the impact of preoperative BTA injection on severity of surgical complications
Severity of complications according to the Clavien-Dindo classification
Measured: During the 90-day postoperative period
Assessment of the impact of preoperative BTA injection on surgical difficulty: abdominal wall closure with CST; incomplete closure of the wall with need of bridge prosthetic repair
Occurrence of CST and occurrence of incomplete wall closure (bridge closure)
Measured: During IH repair surgery
Assessment of the impact of preoperative BTA injection on radiological response:lateral muscles elongation
Sum of the length variation of the left and right lateral muscles (cm)
Measured: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response:lateral muscles elongation
Sum of the width variation of the left and right lateral muscles (cm)
Measured: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response: muscular defect reduction
Width (cm) variation of the muscular defect
Measured: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response: muscular defect reduction
Surface(cm²) variation of the muscular defect
Measured: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response: hernia sac volume
Volume (cm3) variation of the peritonial sac
Measured: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on intra-abdominal pressure, monitored until bladder catheter removal
Measurement of intravesical pressure
Measured: From catheter insertion to removal
Assessment of the impact of preoperative BTA injection on consequences of repair on pain evolution and consumption of analgesics
Pain on Analogical Visual Scale, prescription of type 3 analgesics
Measured: From 1st to 7th postoperative day and at 1, 3 , 6, and 12 months after surgery
Assessment of the impact of preoperative BTA injection repair results: post-operative abdominal wall disruption , clinical and radiological recurrence of the IH
Occurrence of post-operative abdominal wall disruption during a 90 days period after surgery, defined as early postoperative abdominal content herniation with or without skin coverage, identified clinically or at CT-scan; Occurrence of clinical recurrence of the IH during the first year after surgery, defined as any fascial defect that was palpable and was located within 7 cm of the site of hernia repair while the patient was in the supine position with legs extended and raised.
Occurrence of radiological recurrence of the IH at 12 months post-surgery; radiologic hernia is defined as any protrusion of abdominal contents including the anterior parietal peritoneum through a discontinuity of the fascial layers on CT performed during follow-up without Valsalva maneuver postoperative occurrence of clinical and radiological recurrence of the IH, or reoperation for recurrence.
Measured: 90 days and 12 months after surgery
Assessment of the impact of preoperative BTA injection on evolution of quality of life
EQ-5D-5L scale
Measured: 90 days, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start17 Jan 2025
- Primary completion4 Aug 2028 (estimated)
- Study completion4 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David MOSZKOWICZ, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499324
- Sponsor's protocol ID
- APHP220805
- Acronym
- INCISOX
- Status last verified
- Jan 2025
- First submitted
- 31 May 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Large Incisional Hernia with Botulinum Toxin a Injection: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06499324
- Acronym / sponsor ID
- INCISOX / APHP220805
- Conditions
- Incisional Hernia
- Keywords
- Incisional Hernia, Botulinum toxin A, Incisional Hernia repair, Laparatomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 4 Aug 2028 (estimated)
- Study completion
- 4 Mar 2029 (estimated)
- First posted
- 12 Jul 2024 (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.
After laparotomy, treating large incisional hernias (width >= 10cm) proves challenging due to the progressive retraction of lateral abdominal muscles and the separation of rectus muscles. This width is a significant risk factor for repair failure and recurrence. High rates of severe postoperative morbidity, up to 50%, are reported, linked to dissection extent, increased muscular tension, and abdominal pressure. Reconstructing normal anatomy by bringing muscles together may be impossible, leading to the use of complex procedures like component separation techniques (CST), involving large aponeurotomy for muscle relaxation. Intramuscular injection of botulinum toxin A (BTA) induces reversible flaccid paralysis, with potential benefits in hernia closure, known as "chemical CST." Retrospective studies suggest reduced muscle retraction and facilitated closure without specific morbidity. Prehabilitation with BTA aims to reduce surgical morbidity compared to repair and CST. The prospective evaluation of BTA's clinical benefits, including reduced postoperative morbidity, pain, successful abdominal closure, and decreased IH recurrence risk, is lacking. A prospective randomized double-blind placebo-controlled trial is proposed to demonstrate BTA's efficacy. The hypothesis is that BTA injection before IH repair is more effective than a placebo in reducing postoperative morbimortality. Secondary expectations include a significant reduction in complete closure of the abdominal wall without CST.
Detailed description
Almost 20% of patients will develop an incisional hernia (IH) after laparotomy. Each year in France, around 30,000 patients undergo IH repair with mesh [PMSI, 2017]. The treatment of large IH (width>=10cm) is difficult due to the progressive retraction of the lateral abdominal muscles associated with the separation of the rectus muscles. The IH width is a major risk factor of failure of the repair and recurrence. Furthermore, high rates of severe postoperative morbidity, up to 50%, have been reported and related to the extent of dissection and increase of muscular tension and abdominal pressure. Thus, bringing the muscles together to reconstruct the normal anatomy may be impossible and lead the surgeon to use complex and morbid technical procedures, such as component separation techniques (CST), consisting in large aponeurotomy for relaxation of the lateral muscles. The intramuscular injection of botulinum toxin A (BTA) makes it possible to obtain a reversible flaccid paralysis of the striated muscle fibers and its advantage has been demonstrated for the treatment of neurological spasticity. Its use to obtain a relaxation of the lateral muscles of the abdomen, so-called "chemical CST", reduce their retraction and facilitate hernia closure, as studied in retrospective studies, without specific morbidity. In particular, prehabilitation with BTA injection, is supposed to reduce surgical morbidity in comparison with surgical repair and CST. The expected clinical benefit, in terms of reduction of postoperative morbidity and pain, successful closure of the abdomen, and reduction of the risk of recurrence of the IH, has never been evaluated prospectively. Thus, a prospective randomized double-blind placebo-controlled trial would be the best method to demonstrate the benefit of BTA injection. The investigators hypothesize that BTA injection in the lateral muscles before IH repair is more effective than placebo injection in reducing postoperative morbimortality. Secondarily, the investigators expect that BTA injection is associated with a significant reduction of complete closure of the abdominal wall without CST.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTA group | Experimental | Drug: BTA groupThis arm corresponds to patients presenting with midline anterior primary or recurrent IH (subxiphoidal to suprapubic) of width >= 10 cm, without loss of domain, scheduled for IH repair with mesh. Patients will be injected with 288 IU of BTA (XEOMIN® 100U) into the lateral muscles (18 injection sites, 16UI/8mL/injection site), 4 to 6 weeks before the treatment of the IH. |
| Placebo group | Placebo comparator | Drug: Placebo groupThis arm corresponds to patients presenting with midline anterior primary or recurrent IH (subxiphoidal to suprapubic) of width >= 10 cm, without loss of domain, scheduled for IH repair with mesh. Patients will be injected with placebo of BTA (XEOMIN® 100U matching placebo) into the lateral muscles (18 injection sites, 8mL/injection site), 4 to 6 weeks before the treatment of the IH. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between 18 and 79 years;
- BMI < 35 kg/m²;
- Midline anterior primary or recurrent IH (subxiphoidal to suprapubic), of width >= 10 cm, on the abdominopelvic CT without injection of contrast agent, performed in the 6 months before inclusion (EHS W3);
- IH without loss of domain, defined by the ratio: (volume of the peritoneal sac) / (total peritoneal volume) < 25%, on the abdominal CT without injection of contrast agent, performed in the 6 months before inclusion;
- Written informed consent;
Key exclusion criteria (20 listed)
- Other types of IH (lateral, groin, para-stomal, portsite);
- VHWG grades 3 or 4 for the risk of surgical site infection;
- Ongoing skin infection or inflammation at the IH site or at the BTA injection site;
- Planned IH repair with slowly absorbable mesh;
- IH with loss of domain (volumetric ratio > 25%);
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 |
|---|---|---|
| BTA groupIt consists of a blind injection of 288 IU (/144mL) of BTA (XEOMIN®) into the lateral muscles (18 injection sites, 16UI/8mL/injection site), 4 to 6 weeks before the treatment of a large anterior IH (width ≥ 10 cm) with open non absorbable mesh repair. The injection of BTA (XEOMIN®) will be done during an outpatient hospitalization, in each of the 3 lateral muscles of the abdomen on each side. To do this in the BTA group, 3 vials of 100 equivalent IU of BTA (XEOMIN® 100U), diluted to 2 IU/mL with 0.9% saline will be distributed in 3 syringes of 50 mL equipped with a 21G needle. A total of 72 mL of BTA solution (144 IU) will be injected on each side, at 3 injection points between the costal rim and iliac crest, under ultrasound control. | Drug | BTA group |
| Placebo groupIt consists of a blind injection of placebo of BTA (XEOMIN® 100U matching placebo) into the lateral muscles (18 injection sites, 8mL/injection site), 4 to 6 weeks before the treatment of a large IH (width >= 10 cm) with open non absorbable mesh repair. The injection of placebo of BTA (XEOMIN® 100U matching placebo) will be done during an outpatient hospitalization, in each of the 3 lateral muscles of the abdomen on each side. To do this in the control group, 3 vials of placebo of BTA (XEOMIN® 100U matching placebo), diluted with 0.9% saline will be distributed in 3 syringes of 50 mL equipped with a 21G needle. A total of 72 mL of placebo of BTA solution will be injected on each side, at 3 injection points between the costal rim and iliac crest, under ultrasound control. | Drug | Placebo group |
Primary outcome
Demonstrate the efficacy of preoperative BTA injection in the lateral abdominal wall muscles reduces the rate of postoperative morbimortality after large IH (width >= 10cm) repair with mesh, compared with placebo injection.
Time frame: During the 90-day postoperative period
Occurrence of Clavien-Dindo classification grade II or higher post-operative complication
12 secondary outcomes
Assessment of the impact of preoperative BTA injection on length of stay.
Time frame: From surgery until hospital discharge, average 5 days
Assessment of the impact of preoperative BTA injection on severity of surgical complications
Time frame: During the 90-day postoperative period
Assessment of the impact of preoperative BTA injection on surgical difficulty: abdominal wall closure with CST; incomplete closure of the wall with need of bridge prosthetic repair
Time frame: During IH repair surgery
Assessment of the impact of preoperative BTA injection on radiological response:lateral muscles elongation
Time frame: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response:lateral muscles elongation
Time frame: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response: muscular defect reduction
Time frame: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response: muscular defect reduction
Time frame: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on radiological response: hernia sac volume
Time frame: Between the pre-inclusion CT-scan and the CT-scan 4 weeks after BTA injection
Assessment of the impact of preoperative BTA injection on intra-abdominal pressure, monitored until bladder catheter removal
Time frame: From catheter insertion to removal
Assessment of the impact of preoperative BTA injection on consequences of repair on pain evolution and consumption of analgesics
Time frame: From 1st to 7th postoperative day and at 1, 3 , 6, and 12 months after surgery
Assessment of the impact of preoperative BTA injection repair results: post-operative abdominal wall disruption , clinical and radiological recurrence of the IH
Time frame: 90 days and 12 months after surgery
Assessment of the impact of preoperative BTA injection on evolution of quality of life
Time frame: 90 days, 6, and 12 months after surgery
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 Jan 2025.
- 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.
David MOSZKOWICZ principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BTA group in people with Incisional Hernia, run by Assistance Publique - Hôpitaux de Paris 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?
The sponsor lists 7 inclusion and 20 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 Jan 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 David MOSZKOWICZ, MD-PhD (+33 (0)1 47 60 66 02, david.moszkowicz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the efficacy of preoperative BTA injection in the lateral abdominal wall muscles reduces the rate of postoperative morbimortality after large IH (width >= 10cm) repair with mesh, compared with placebo injection. (time frame: During the 90-day postoperative period). 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 22 Jan 2025.