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Completed

NCT Number: NCT07401082

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

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.

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Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

About this study

This study is a prospective, single-center, randomized controlled trial designed to compare the postoperative outcomes associated with three distinct mesh fixation modalities in laparoscopic Trans-Abdominal Pre-Peritoneal (TAPP) inguinal hernia repair.

Scientific Rationale:

While mesh reinforcement has drastically reduced recurrence rates in hernia surgery, chronic postoperative pain and mesh-related discomfort remain significant concerns that impact patient quality of life. The method of securing the mesh is hypothesized to be a key factor influencing these outcomes. Mechanical fixation with tacks or sutures may cause tissue trauma or nerve irritation, whereas adhesive fixation provides an atraumatic alternative. Direct comparative data on these three common techniques(glue, sutures, and tacks) within the standardized TAPP procedure is limited.

Study Design:

A total of 75 eligible participants will be enrolled and equally randomized into one of three parallel intervention arms in a 1:1:1 ratio. The randomization sequence will be computer-generated. Due to the nature of the interventions, blinding of the surgeon is not feasible; however, outcome assessors and the statistician will be blinded to group assignment where possible.

Interventional Protocol:

All participants will undergo a standardized TAPP procedure under general anesthesia. After creation of the preperitoneal space and placement of a polypropylene mesh over the myopectineal orifice, fixation will be performed according to the assigned group:

Glue Fixation Group: Fixation using a cyanoacrylate-based surgical adhesive (e.g., Glubran-2®) applied with a specific applicator.

Suture Fixation Group: Fixation using two non-absorbable polypropylene sutures placed at the medial and lateral ends of the mesh.

Tack Fixation Group: Fixation using helical titanium tacks (e.g., ProTack®), with careful avoidance of the "triangle of doom" and "triangle of pain" anatomical zones.

Follow-up and Assessments:

Participants will be followed for a period of six months postoperatively. Structured assessments will occur at designated intervals:

Pain Assessment: Measured using the Visual Analogue Scale (VAS) on postoperative day 1 and at 1, 3, and 6 months.

Quality of Life and Mesh Sensation: Assessed using the Carolinas Comfort Scale (CCS), a validated hernia-specific questionnaire, at 1, 3, and 6 months.

Clinical Outcomes: Operative time, length of hospital stay, time to return to normal work/activities, incidence of complications (seroma, hematoma, infection), and hernia recurrence will be systematically recorded.

Statistical Analysis:

Data will be analyzed on an intention-to-treat basis. Continuous variables will be compared using ANOVA or Kruskal-Wallis tests as appropriate, followed by post-hoc pairwise comparisons. Categorical variables will be analyzed using the Chi-square or Fisher's exact test. A p-value of <0.05 will be considered statistically significant.

Study Significance:

This trial aims to provide high-level evidence to guide surgical practice by identifying the mesh fixation technique associated with the most favorable balance of reduced postoperative pain, improved quality of life, and cost-effectiveness, without compromising the durability of the repair.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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).

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.

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.

Primary outcomes

  1. Postoperative Pain Intensity

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

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

  2. Postoperative Quality of Life and Mesh Sensation

    Time frame: Assessed at 1 month, 3 months, and 6 months postoperatively.

    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.

  3. Operative Time

    Time frame: Recorded on the day of surgery.

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

Secondary outcomes

  1. Hernia Recurrence

    Time frame: Assessed at 6 months postoperatively.

    Clinical or radiological evidence of recurrent inguinal hernia at the operated site.

  2. Time to Return to Work/Normal Activity

    Time frame: Assessed within the first 4 weeks postoperatively.

    Number of days from surgery until the patient returns to their regular employment or daily activities.

  3. Length of Hospital Stay

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

    Number of days from surgery to discharge from the hospital.

  4. Postoperative Complications

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

    Incidence of surgical complications including seroma, hematoma, wound infection, mesh infection, and scrotal edema.

  5. Direct Material Cost of Mesh Fixation Device

    Time frame: Recorded on the day of surgery.

    The direct material cost of the specific fixation device used in each study arm is recorded in US Dollars (USD). Costs are categorized into three predetermined ranges based on hospital procurement prices: Low ($30-60), Moderate ($200-300), and High ($350-500). Data will be aggregated and reported as the proportion of participants in each study arm falling into these cost categories.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Postoperative Pain and Quality of Life With Different Modalities of Mesh Fixation in Laparoscopic Trans-Abdominal Pre-Peritoneal Repair of Inguinal Hernia. A Randomized Controlled Trial

Acronym: RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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