Self-Fixating Mesh Versus Mesh Fixation With Tissue Glue in Laparoscopic Inguinal Hernia Repair

NCT06412445 | Enrolling By Invitation

• 1 other identifier: Mesh Fixation Methods in TAPP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare between the safety and efficacy of self-fixating mesh versus mesh fixation with tissue glue in patients undergoing laparoscopic transabdominal inguinal hernia repair (TAPP). The criteria of comparison shall include operating time, post-operative pain and recurrence.

Conditions

Inguinal Hernia

Keywords

TAPP; Self-Fixating Mesh; Mesh Fixation; Tissue Glue; Laparoscopic Transabdominal Inguinal Hernia Repair; Inguinal Hernia Repair

Outcome Measures

Primary Outcomes (2)

• Hernia recurrence

  clinical or radiological at any time point

  Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months

• Chronic pain

  pain persisting beyond three months postoperatively. Post-operative pain will be evaluated based on the numerical rating scale (NRS) 0-10, for pain self-reporting with reference to the patient's individual experience, where 0 indicates no pain, 1-3 mild pain, 4-6 moderate pain and 7-10 disabling severe pain

  Follow up of all patients will be done post-operatively as outpatients after discharge on day 15, and after 3, 6 and 12 months

Secondary Outcomes (8)

• Length of surgery

  1 to 3 hours

• Immediate postoperative pain

  1 to 3 days

• Vascular/visceral injury

  1 to 3 hours

• Haematoma/seroma development

  1 to 7 days

• Length of hospital stay

  1 to 7 days

Study Arms (2)

Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue

ACTIVE COMPARATOR

Patients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair having there mesh fixated with tissue glue. Glubran 2® surgical glue is a medical device Class III CE marked for internal and external use. It is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer synthesized by the manufacturer GEM. It is ready for use. It has high adhesive and haemostatic properties and once it is polymerised it creates an efficient antiseptic barrier against the most diffused infective or pathogenic agents during the surgical intervention. It polymerizes quickly in contact with live tissue and wet environment creating a thin and elastic film having high tensile properties which guarantee strong adhesion to the tissues. This film naturally conforms with the tissues on which it is applied; it is not permeable to liquids and is not altered by blood or organic liquids

Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation

Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh

ACTIVE COMPARATOR

Patients aged from 18 to 60 years with unilateral direct or indirect inguinal hernia who will undergo laparoscopic TAPP inguinal hernia repair with self fixating mesh. Covidien ProGrip mesh is a self-gripping polyester mesh, 15x15 cm in size, it is equipped with resorbable microgrip technology which provides immediate fixation of the entire mesh surface for a secure repair and even distribution of tension for patient comfort. The resorbable polylactic acid (PLA) microgrips enable surgeons to position and place the mesh in under 60 seconds, without the use of additional fixation. Surgeons and patients can depend on a secure repair with the potential for greater patient comfort. According to the manufacturer, the time for degradation of the quickly absorbing layer is \< 1 day and that for the layer with microgrips \> 18 months

Procedure: Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh

Interventions

Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair applying tissue glue for mesh fixation PROCEDURE

The operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving applying tissue glue for mesh fixation. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures.

Patients with unilateral inguinal hernia undergoing TAPP repair and mesh fixation with tissue glue

Laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair using self-fixating mesh PROCEDURE

The operation will be performed using 3 trocars, with 10 mm trocar above the umbilicus and 5 mm and 12 mm trocars at the level of the umbilicus in the left and right midclavicular lines. Pneumoperitoneum will be established and a 30° optic will be used. After accessing the inguinal region, dissection of the parietal peritoneum will be performed in the direction from the anterior superior iliac spine up to the medial umbilical ligament. During dissection, gonadal vessels, vas deferens, Cooper's ligament and the posterior fascia of the rectus abdominis muscle will be visualized and prepared. Then, the prepared implant sized 15×15 cm will be introduced, spread out in the abdominal cavity and placed in the groin in order to cover the hernia opening by 2-3 cm in all directions. Fixation will be based on a mechanical effect involving the adherence of grips to tissue using self-fixating mesh. Reconstruction of the parietal peritoneum will be followed, with continuous absorbable sutures.

Also known as: TAPP procedure

Patients with unilateral inguinal hernia undergoing TAPP repair with self fixating mesh

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unilateral direct or indirect inguinal hernia

You may not qualify if:

• Bilateral hernia.
• Femoral hernia.
• Inguinoscrotal hernia.
• Complicated inguinal hernias.
• Recurrent inguinal hernias.
• Morbid obesity.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University Hospitals

Cairo, 11795, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Assistant Lecturer

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 14, 2024
• Study Start: December 20, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)