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

NCT ID: NCT05929378

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hernia, Inguinal Chronic Pain Seroma Recurrence Infections Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lightweight mesh fixation

Intervention Type PROCEDURE

Lightweight mesh fixation in 3 points

1-point fixation group

Lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis.

Group Type ACTIVE_COMPARATOR

Lightweight mesh fixation

Intervention Type PROCEDURE

Lightweight mesh fixation in 3 points

Interventions

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Lightweight mesh fixation

Lightweight mesh fixation in 3 points

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'an People's Hospital

UNKNOWN

Sponsor Role collaborator

Pengan County People's Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Yilong County

UNKNOWN

Sponsor Role collaborator

Nanbu Hospital of County Chinese Medicine

OTHER

Sponsor Role collaborator

Nanchong Jialing District People's Hospital

UNKNOWN

Sponsor Role collaborator

Langzhong People's Hospital

UNKNOWN

Sponsor Role collaborator

Langzhong Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Nanchong Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yunhong Tian

Director of Gastrointestinal, Colorectal and Hernia Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yunhong Tian

Nanchong, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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2023031

Identifier Type: -

Identifier Source: org_study_id

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