A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia

• Sponsor: Nanchong Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05929378
• Collaborator: (none)
• Enrollment: 206
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 18.8

Study Details

Study Description

Brief Summary

This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal; Chronic Pain; Seroma; Recurrence; Infections; Hematoma	Procedure: Lightweight mesh fixation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 206 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3-point fixation group Lightweight Mesh Fixation with 3-point Fixation. First fixation is in cooper ligament. Second fixation is in the back of rectus abdominis. Third fixation is in the later of tractus iliopubicus.	Procedure: Lightweight mesh fixation; Lightweight mesh fixation in 3 points
Active Comparator: 1-point fixation group Lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis.	Procedure: Lightweight mesh fixation; Lightweight mesh fixation in 3 points

Outcome Measures

Primary Outcome Measures

1. recurrence [6 months]

   Check for recurrence by clinical examination or ultrasound at 6 months postoperatively

2. Postoperative pain [6 months]

   The visual analog scale (VAS) was adopted for pain evaluation 2 days, 3 months, and 6 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.

Secondary Outcome Measures

1. postoperative complications [6 months]

   Including infection, seroma, hematoma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination.

The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)

Exclusion Criteria:

Female patients Age below 18 years or older than 80. Direct hernia, femoral hernia, recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias.

Patients not suitable for general anesthesia. Patients requiring open surgery; patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yunhong Tian	Nanchong	Sichuan	China	637000

Sponsors and Collaborators

• Nanchong Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yunhong Tian, Director of Gastrointestinal, Colorectal and Hernia Surgery, Nanchong Central Hospital
• ClinicalTrials.gov Identifier: NCT05929378
• Other Study ID Numbers: 2023031
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 5, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Chronic Pain; Hernia; Recurrence; Hernia, Inguinal; Hematoma

Study Results

No Results Posted as of Jul 5, 2023