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

NCT06412445 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-14

No results posted yet for this study

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

Interventions

PROCEDURE

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

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.

PROCEDURE

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

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.

Sponsors & Collaborators

  • Helwan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06412445 on ClinicalTrials.gov