Only Mesh Fixation With Glue of Ventral/Incisional Laparoscopic Hernia Repair

NCT06183840 | Not Yet Recruiting

• 1 other identifier: Rafael Villalobos
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

This multicenter randomized controlled non-inferiority trial of only mesh fixation with a glue applicator is a trial to evaluate the outcomes between atraumatic laparoscopic mesh fixation with GLUTACK-Glubran2® and conventional traumatic fixation, so the primary endpoint of the study is to analyze the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.

Conditions

Ventral Incisional Hernia

Keywords

Ventral hernia; Incisional hernia; Mesh; Glue; Tackers; IPOM plus

Outcome Measures

Primary Outcomes (1)

• Rate of the recurrence on ventral or incisional hernia repair 2 years postoperatively assessed by a clinical and/or imaging technique.

  The fixation of the mesh with atraumatic material with glue is as good as the conventional traumatic fixation

  2 years

Secondary Outcomes (3)

• Rate of postoperative pain between atraumatic and traumatic fixation of the mesh (EuraHS Quality of life scale: 0-10). Ten is the worst outcome

  2 years

• Types of comorbidities related on the surgery as visceral adhesions, seroma, hematoma, bulging, port site incisional hernia, recurrence

  2 years

• Quality of life (QoL) between the two types of fixations with the EuraHS scale at 1 month, 6 months, 12 months, and 24 months. EurasHS scale of 10 is the worst outcome

  2 years

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Patients with a traumatic fixation of the mesh

Device: Conventional

Glutack

EXPERIMENTAL

Patient with Glutack mesh fixation

Device: Glutack

Interventions

Glutack DEVICE

Three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm: Glutack

Glutack

Conventional DEVICE

Three ports are used (1x11 mm and 2x5 mm) and after adhesiolysis and the field prepared, the defect is measured with a local standard in a craneo-caudal and transversal directions. Then, the defect is closed with a 2-0 caliber barbed suture following its biggest axis. A Dynamesh IPOM previously hydrated (2-3 min) is introduced throughout the 11mm trocar and extended. After this maneuver, mesh fixation is performed depending on the randomized arm: Traumatic fixation

Also known as: Traumatic fixation

Conventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults with a BMI lesser than 35 Kg/m2 undergoing an elective laparoscopic primary ventral or incisional hernia repair with a fascial transverse defect between 4-8 cm (W2 EHS) on anterior or lateral location (M1-M5 up to 10 cm of length or L1-3)
• ASA grade from I-II
• Informed consent signed

You may not qualify if:

• Patients less than 18 years and over 80 years of age.
• Fascial transverse defect less than 4 cm and more than 8 cm.
• Recurrent ventral or incisional hernia in the same place
• Emergency surgery
• Procedure involving concomitant surgeries (e.g. gastrointestinal, biliary or genitourinary surgery)
• BMI greater than 35 Kg/m2
• ASA III-IV
• Pregnancy
• Tobacco

Sponsors & Collaborators

• Institut Catala de Salut: lead

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Abdominal Wall Unit Surgery

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 28, 2023
• Study Start: March 10, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03