Mesh Fixation Methods in Laparoscopic Hernia Repair: Glue vs. Sutures vs. Tacks (RCT)
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About
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.
Full description
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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
75 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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