- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131348
Botulinum Toxin to Avoid Component Separation in Midline Large Hernias (BTCS01)
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).
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Valencia, Spain, 46008
- Jose Bueno-Lledo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with LMIH with hernia transverse defect between 12 and 18 cms in preoperative CT scan
- grade W3 in EHS classification
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: CSG
patients underwent open CST (component separation group or CSG)
|
From to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center.
|
Other: BTG
patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).
|
From to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical site ocurrences after hernia repair.
Time Frame: two years
|
focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups
|
two years
|
primary fascial closure
Time Frame: two years
|
possibility of free-tension closure
|
two years
|
lenght of stay
Time Frame: two years
|
lenght of hospital stay after hernia repair
|
two years
|
recurrence rate
Time Frame: two years
|
hernia recurrence rate after surgery in both groups
|
two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Hernia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- BTCS001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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