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

N

Nanchong Central Hospital

Status

Completed

Conditions

Seroma
Hernia, Inguinal
Chronic Pain
Infections
Recurrence
Hematoma

Treatments

Procedure: Lightweight mesh fixation

Study type

Interventional

Funder types

Other

Identifiers

NCT05929378
2023031

Details and patient eligibility

About

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.

Enrollment

351 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

351 participants in 2 patient groups

3-point fixation group
Experimental group
Description:
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.
Treatment:
Procedure: Lightweight mesh fixation
1-point fixation group
Active Comparator group
Description:
Lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis.
Treatment:
Procedure: Lightweight mesh fixation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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