Mesh Fixation Methods in Laparoscopic Hernia Repair: Glue vs. Sutures vs. Tacks

NCT07401082 | Completed

• 1 other identifier: MS-358-2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical trial that aims to compare three different methods for securing a surgical mesh during a specific type of groin (inguinal) hernia repair surgery. The surgery is performed using a minimally invasive, keyhole technique called TAPP. The main questions this study aims to answer are: Which mesh fixation method-surgical glue, stitches (sutures), or small metal coils (tacks)-results in less pain for patients after surgery? Which method leads to a better quality of life and less feeling of the mesh inside the body after recovery? Is there a difference in how long the surgery takes with each method? To answer these questions, researchers will compare the three methods to see which one works best for patient comfort and recovery. Adults aged 21-60 years with a new inguinal hernia who are having laparoscopic TAPP surgery can participate. Participants will be randomly assigned to one of three groups: Group 1: Their mesh will be secured using surgical glue. Group 2: Their mesh will be secured using stitches (sutures). Group 3: Their mesh will be secured using small metal coils (tacks). All other parts of the surgery and care after surgery will be the same. Participants will: Have the laparoscopic TAPP hernia repair surgery. Report their pain levels after surgery using a simple scale. Answer questions about their comfort and quality of life during follow-up visits at 1, 3, and 6 months after surgery.

Conditions

Inguinal Hernia

Keywords

Inguinal hernia; Laparoscopic Hernia Repair; TAPP; Transabdominal Preperitoneal Repair; Mesh Fixation; Surgical Glue; Cyanoacrylate; Sutures; Tacks; Carolinas Comfort Scale; Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain Intensity

  Intensity of pain measured using the Visual Analogue Scale (VAS), a 10-point scale where 0 = no pain and 10 = worst pain imaginable.

  Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively.

• Postoperative Quality of Life and Mesh Sensation

  Patient-reported quality of life and mesh-related symptoms were measured using the Carolinas Comfort Scale (CCS), a validated hernia-specific outcome measure. The CCS consists of 23 items evaluating pain, mesh sensation, and movement limitation during daily activities, each scored from 0 (no symptoms) to 5 (disabling symptoms), yielding a total score range of 0-115. Higher scores indicate worse postoperative comfort and quality of life.

  Assessed at 1 month, 3 months, and 6 months postoperatively.

• Operative Time

  Total duration of surgery, measured from skin incision to skin closure (in minutes).

  Recorded on the day of surgery.

Secondary Outcomes (5)

• Hernia Recurrence

  Assessed at 6 months postoperatively.

• Time to Return to Work/Normal Activity

  Assessed within the first 4 weeks postoperatively.

• Length of Hospital Stay

  Measured during the immediate postoperative period (typically 1-2 days).

• Postoperative Complications

  Assessed on postoperative Day 1 and at 1 month, 3 months, and 6 months postoperatively

• Direct Material Cost of Mesh Fixation Device

  Recorded on the day of surgery.

Study Arms (3)

Glue Mesh Fixation

EXPERIMENTAL

Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using a cyanoacrylate-based surgical adhesive (Glubran-2®) applied via a dedicated applicator (GlueTack device). The mesh will be secured with small drops of glue at its corners.

Device: Cyanoacrylate Surgical Adhesive Fixation; Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .

Suture Mesh Fixation

EXPERIMENTAL

Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh. This is a traditional mechanical fixation method.

Procedure: Suture Mesh Fixation; Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .

Tack Mesh Fixation

ACTIVE COMPARATOR

Participants in this arm will undergo laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair with mesh fixation using helical titanium tacks (e.g., ProTack®). This is a standard mechanical fixation method commonly used in laparoscopic hernia repair. Tacks are placed around the periphery of the mesh, avoiding critical neurovascular zones.

Device: Helical Titanium Tack Fixation; Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. .

Interventions

Cyanoacrylate Surgical Adhesive Fixation DEVICE

Fixation of the polypropylene mesh using a cyanoacrylate-based surgical adhesive (Glubran-2®). The adhesive is applied in small drops at the mesh corners using a specific applicator device (GlueTack) to secure the mesh to the abdominal wall without mechanical penetration.

Glue Mesh Fixation

Suture Mesh Fixation PROCEDURE

Fixation of the polypropylene mesh using two non-absorbable polypropylene sutures. The sutures are placed laparoscopically at the medial and lateral ends of the mesh to mechanically secure it to the abdominal wall tissues (e.g., Cooper's ligament, transversalis fascia).

Suture Mesh Fixation

Helical Titanium Tack Fixation DEVICE

Fixation of the polypropylene mesh using multiple helical titanium tacks ( ProTack®). The tacks are fired laparoscopically around the periphery of the mesh, penetrating the abdominal wall to mechanically secure the mesh in place, while avoiding anatomical danger zones.

Tack Mesh Fixation

Laparoscopic Transabdominal Preperitoneal (TAPP) Inguinal Hernia Repair with Polypropylene Mesh Fixation. . PROCEDURE

All participants in this study will undergo Laparoscopic Transabdominal Preperitoneal (TAPP) Repair of Inguinal Hernia, which is the standard surgical procedure. This minimally invasive technique involves: Creation of Pneumoperitoneum: The abdominal cavity is inflated with carbon dioxide gas. Port Placement: Three small incisions are made for camera and instrument ports. Peritoneal Incision: The peritoneum (inner abdominal lining) is cut to access the preperitoneal space in the groin. Hernia Reduction: The hernia sac and contents are pushed back into the abdominal cavity. Mesh Placement: A synthetic polypropylene mesh is positioned to cover the entire myopectineal orifice (the weak area where hernias occur). Mesh Fixation: The mesh is secured using one of three study methods (glue, sutures, or tacks) according to the assigned intervention arm. Peritoneal Closure: The initial peritoneal incision is closed over the mesh to isolate it from the abdominal organs.

Glue Mesh Fixation; Suture Mesh Fixation; Tack Mesh Fixation

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 21 to 60 years
• Diagnosis of primary (de novo) inguinal hernia
• Hernia type: unilateral or bilateral, direct or indirect
• Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) repair
• Able to provide informed consent

You may not qualify if:

• Age \<21 or \>60 years
• Recurrent inguinal hernia
• Complicated hernia (irreducible, incarcerated, obstructed, or strangulated)
• Contraindication to laparoscopic surgery or general anesthesia
• Significant comorbid conditions making surgery high-risk (ASA class ≥III)
• Chronic pain syndrome or regular use of strong analgesics
• Allergy to mesh materials (polypropylene) or fixation components (cyanoacrylate, titanium)
• Participation in another clinical trial
• Inability to complete follow-up or comply with study protocol

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

tetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed Eid Aziz

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants are randomized into one of three parallel groups (glue, sutures, tacks) and remain in that group for the duration of the study. All groups undergo the same surgical procedure (TAPP) with only the mesh fixation method differing.

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 10, 2026
• Study Start: September 26, 2024
• Primary Completion: March 5, 2025
• Study Completion: October 1, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)