Botulinum Toxin to Avoid Component Separation in Midline Large Hernias (BTCS01)
Primary Purpose
Botulinum Toxin Type A, Rives Repair, Large Midline Hernia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Botulinum Toxin Type A
Eligibility Criteria
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.
Sites / Locations
- Jose Bueno-Lledo
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CSG
BTG
Arm Description
patients underwent open CST (component separation group or CSG)
patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).
Outcomes
Primary Outcome Measures
surgical site ocurrences after hernia repair.
focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups
primary fascial closure
possibility of free-tension closure
lenght of stay
lenght of hospital stay after hernia repair
recurrence rate
hernia recurrence rate after surgery in both groups
Secondary Outcome Measures
Full Information
NCT ID
NCT04131348
First Posted
October 14, 2019
Last Updated
October 17, 2019
Sponsor
Hospital Universitario La Fe
1. Study Identification
Unique Protocol Identification Number
NCT04131348
Brief Title
Botulinum Toxin to Avoid Component Separation in Midline Large Hernias
Acronym
BTCS01
Official Title
Botulinum Toxin to Avoid Component Separation in Midline Large Hernias
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Botulinum Toxin Type A, Rives Repair, Large Midline Hernia, Component Separation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSG
Arm Type
Other
Arm Description
patients underwent open CST (component separation group or CSG)
Arm Title
BTG
Arm Type
Other
Arm Description
patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).
Intervention Type
Procedure
Intervention Name(s)
botulinum toxin type A
Intervention Description
From to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center.
Primary Outcome Measure Information:
Title
surgical site ocurrences after hernia repair.
Description
focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups
Time Frame
two years
Title
primary fascial closure
Description
possibility of free-tension closure
Time Frame
two years
Title
lenght of stay
Description
lenght of hospital stay after hernia repair
Time Frame
two years
Title
recurrence rate
Description
hernia recurrence rate after surgery in both groups
Time Frame
two years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jose Bueno-Lledo
City
Valencia
ZIP/Postal Code
46008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Botulinum Toxin to Avoid Component Separation in Midline Large Hernias
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