Botulinum Toxin to Avoid Component Separation in Midline Large Hernias

NCT04131348 | Completed

• 1 other identifier: BTCS001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Botulinum Toxin Type A; Rives Repair; Large Midline Hernia; Component Separation

Outcome Measures

Primary Outcomes (4)

• surgical site ocurrences after hernia repair.

  focusing on the SSO (seroma, ischemia, infection) after hernia repair in both groups

  two years

• primary fascial closure

  possibility of free-tension closure

  two years

• lenght of stay

  lenght of hospital stay after hernia repair

  two years

• recurrence rate

  hernia recurrence rate after surgery in both groups

  two years

Study Arms (2)

CSG

OTHER

patients underwent open CST (component separation group or CSG)

Procedure: botulinum toxin type A

BTG

OTHER

patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).

Procedure: botulinum toxin type A

Interventions

botulinum toxin type A PROCEDURE

From to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center.

BTG; CSG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with LMIH with hernia transverse defect between 12 and 18 cms in preoperative CT scan
• grade W3 in EHS classification

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Jose Bueno-Lledo

Valencia, 46008, Spain

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of section

Model Details: prospective

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: October 1, 2019
• Last Updated: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)