Botulinum Toxin Type ABTCS01NCT04131348
Botulinum Toxin to Avoid Component Separation in Midline Large Hernias
A study testing botulinum toxin type A in people with Botulinum Toxin Type A and Rives Repair, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
Introduction. The goal of our study was to compare results in patients with large midline incisional hernia (LMIH) using only anterior compònent separation (CST) versus preoperative botulinum toxin (BT) and following Rives repair (RSR). Material and methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Botulinum Toxin Type A, Rives Repair, Large Midline Hernia
- What is being tested?
- botulinum toxin type A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2016to 1 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with LMIH with hernia transverse defect between 12 and 18 cms in preoperative CT scan
- grade W3 in EHS classification
Who cannot join
- patients with loss of domain hernia (Tanaka index over 20% in CT scan)
- laparoscopic approaches
- hernias not involving the midline, such as isolated flank and parastomal defects.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction. The goal of our study was to compare results in patients with large midline incisional hernia (LMIH) using only anterior compònent separation (CST) versus preoperative botulinum toxin (BT) and following Rives repair (RSR).
Material and methods. From to December 2016 to December 2018, a prospective comparative study was performed in 80 consecutive patients with LMIH and hernia transverse diameter between 12-18 cms at our tertiary center. Two groups were prospectively analyzed: patients underwent open CST (component separation group or CSG) and patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).
Read the detailed description
Multiple techniques have been described to decrease tension in the closure of the hernia defect in the large midline incisional hernias (LMIH) (1). Anterior component separation (CST) has demonstrated to accomplish primary fascial closure, while maintaining normal anatomy and physiology of the abdominal wall (2,3). However, described limitations of this technique are complications involving the skin and subcutaneous tissue, most likely caused by surgical interruption of perforating vessels during exposure of the external oblique muscle. So, CST has been related to surgical site occurrences (SSO), especially skin necrosis, up to 17% of cases, as well as recurrence rates between 7 and 18% (4).
On the other hand, botulinum toxin type A (BT) has been reported as a therapeutic option to decrease tension of a fascial closure in LMIH (5). It is a neurotoxin that causes a reversible denervation and paralisis of the lateral abdominal muscle, and has been considered as a "chemichal component separation" by some working groups (6). Our long experience about use of preoperative techniques like BT and progressive pneumperitoneum (PPP) allowed us to raise the possibility of planning the isolated use of BT in case of long transverse hernia diameters in patients with LMIH (7).
Taking advantage of the beneficial effect of the neurotoxin, we considered interesting to try to downstage the CST to other hernia repair with less morbidity, like Rives-Stoppa retromuscular repair (RSR). This technique has been traditionally considered the gold standard technique in midline hernias, especially in hernia defects with transverse diameters around or less than 10 cms, and appears to be more advantageous compared to other surgical techniques concerning complications and recurrence rates (8). RSR achieves several objectives: a tension-free closure due to extensive overlap between the prosthesis and the fascial edges, and the placement of the mesh next to the vascular-rich rectus muscles facilitates tissue incorporation and minimizing complications related to SSO (9).
The objective of our study was to compare results in two groups of patients with LMIH, using only CST versus preoperative BT plus following RSR, focusing on the SSO, possibility of primary fascial closure, length of hospital stay and hernia recurrence rate.
- Being tested
- botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin type AProcedure or surgery
From to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center.
| Study group | Role | What they receive |
|---|---|---|
| CSG | Other | patients underwent open CST (component separation group or CSG) Receives: Procedure: botulinum toxin type A |
| BTG | Other | patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG). Receives: Procedure: botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site ocurrences after hernia repair.
focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups
Measured: two years
primary fascial closure
possibility of free-tension closure
Measured: two years
lenght of stay
lenght of hospital stay after hernia repair
Measured: two years
recurrence rate
hernia recurrence rate after surgery in both groups
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Dec 2016
- Primary completion1 Dec 2018
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Botulinum Toxin Type AStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE BUENO-LLEDÓ, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131348
- Sponsor's protocol ID
- BTCS001
- Acronym
- BTCS01
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 21 Oct 2019
- 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 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin to Avoid Component Separation in Midline Large Hernias
- ClinicalTrials.gov ID
- NCT04131348
- Acronym / sponsor ID
- BTCS01 / BTCS001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 18 Oct 2019 (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.
Introduction. The goal of our study was to compare results in patients with large midline incisional hernia (LMIH) using only anterior compònent separation (CST) versus preoperative botulinum toxin (BT) and following Rives repair (RSR).
Material and methods. From to December 2016 to December 2018, a prospective comparative study was performed in 80 consecutive patients with LMIH and hernia transverse diameter between 12-18 cms at our tertiary center. Two groups were prospectively analyzed: patients underwent open CST (component separation group or CSG) and patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).
Detailed description
Multiple techniques have been described to decrease tension in the closure of the hernia defect in the large midline incisional hernias (LMIH) (1). Anterior component separation (CST) has demonstrated to accomplish primary fascial closure, while maintaining normal anatomy and physiology of the abdominal wall (2,3). However, described limitations of this technique are complications involving the skin and subcutaneous tissue, most likely caused by surgical interruption of perforating vessels during exposure of the external oblique muscle. So, CST has been related to surgical site occurrences (SSO), especially skin necrosis, up to 17% of cases, as well as recurrence rates between 7 and 18% (4).
On the other hand, botulinum toxin type A (BT) has been reported as a therapeutic option to decrease tension of a fascial closure in LMIH (5). It is a neurotoxin that causes a reversible denervation and paralisis of the lateral abdominal muscle, and has been considered as a "chemichal component separation" by some working groups (6). Our long experience about use of preoperative techniques like BT and progressive pneumperitoneum (PPP) allowed us to raise the possibility of planning the isolated use of BT in case of long transverse hernia diameters in patients with LMIH (7).
Taking advantage of the beneficial effect of the neurotoxin, we considered interesting to try to downstage the CST to other hernia repair with less morbidity, like Rives-Stoppa retromuscular repair (RSR). This technique has been traditionally considered the gold standard technique in midline hernias, especially in hernia defects with transverse diameters around or less than 10 cms, and appears to be more advantageous compared to other surgical techniques concerning complications and recurrence rates (8). RSR achieves several objectives: a tension-free closure due to extensive overlap between the prosthesis and the fascial edges, and the placement of the mesh next to the vascular-rich rectus muscles facilitates tissue incorporation and minimizing complications related to SSO (9).
The objective of our study was to compare results in two groups of patients with LMIH, using only CST versus preoperative BT plus following RSR, focusing on the SSO, possibility of primary fascial closure, length of hospital stay and hernia recurrence rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective
| Arm | Type | Receives |
|---|---|---|
| CSG | Other | Procedure: botulinum toxin type Apatients underwent open CST (component separation group or CSG) |
| BTG | Other | Procedure: botulinum toxin type Apatients with preoperative BT administration and following open RSR (botulinum toxin group or BTG). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with LMIH with hernia transverse defect between 12 and 18 cms in preoperative CT scan
- grade W3 in EHS classification
Key exclusion criteria (3 listed)
- patients with loss of domain hernia (Tanaka index over 20% in CT scan)
- laparoscopic approaches
- hernias not involving the midline, such as isolated flank and parastomal defects.
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 |
|---|---|---|
| botulinum toxin type AFrom to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center. | Procedure or surgery | BTG, CSG |
Primary outcome
surgical site ocurrences after hernia repair.
Time frame: two years
focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups
primary fascial closure
Time frame: two years
possibility of free-tension closure
lenght of stay
Time frame: two years
lenght of hospital stay after hernia repair
recurrence rate
Time frame: two years
hernia recurrence rate after surgery in both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- 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.
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?
A study testing botulinum toxin type A in people with Botulinum Toxin Type A and Rives Repair, run by Hospital Universitario La Fe 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
surgical site ocurrences after hernia repair. (time frame: two years). The study lists 4 primary outcomes in all. 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 21 Oct 2019.