Outcomes of Mesh Fixation Versus Non Fixation in Laparoscopic TAPP Inguinal Hernia Repair

NCT05430984 | Completed

• 1 other identifier: MKSU50-6-16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This work aims to study the outcomes of mesh fixation versus non-fixation of laparoscopic TAPP inguinal hernia repair as regards postoperative pain, recurrence, operative time, and other postoperative complications.

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  the degree of pain after surgery in the inguinal region assessed by numerical rating score

  12 months

Study Arms (2)

Laparoscopic TAPP inguinal hernia repair with mesh fixation

ACTIVE COMPARATOR

the mesh will be fixed to the abdominal wall using suture, spiral tacks.

Procedure: Laparoscopic TAPP inguinal hernia repair

Laparoscopic TAPP inguinal hernia repair without mesh fixation

ACTIVE COMPARATOR

the mesh will be left as it is and the operation will be concluded

Procedure: Laparoscopic TAPP inguinal hernia repair

Interventions

Laparoscopic TAPP inguinal hernia repair PROCEDURE

Isolation of preperitoneal space will be accomplished to guarantee the mesh flattening with the medial border at the pubic symphysis, the lateral border at the psoas major and anterior superior iliac spine, superior border at least 3 cm above the conjoined tendon, medial inferior border 3 cm below the pectineal ligament, and lateral inferior border to permit perietalization of the spermatic cord (6-8 cm isolation of the hernia sac and spermatic cord). For the mesh fixation group, the mesh will be fixed to the abdominal wall using suture, spiral tacks, whereas for the non-fixation group it will be left as it is and the operation will be concluded. A mesh measuring 15x10cm is placed in the preperitoneal space and fixed using limited numbers of tacks or suture. In some cases, based on body habitus, a slightly smaller mesh could be used. The peritoneum will be closed over the mesh.

Laparoscopic TAPP inguinal hernia repair with mesh fixation; Laparoscopic TAPP inguinal hernia repair without mesh fixation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of either gender, aged between 18 and 65 years, who had early diagnosed inguinal hernia (unilateral or bilateral)

You may not qualify if:

• patients with a recurrent hernia, inguinoscrotal hernia, complicated hernia (incarcerated or strangulated), known ascites or connective tissue disease, heart and kidney failure, and hypoalbuminemia

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, assistant lecturer of General Surgery

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: December 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

EG (1)