Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair

NCT ID: NCT06240858

Last Updated: 2024-02-06

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-11-30

Brief Summary

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The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.

Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.

Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAPP group

The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair.

Group Type EXPERIMENTAL

Laparoscopic transabdominal preperitoneal hernia repair.

Intervention Type PROCEDURE

The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.

Lichtenstein group

The Lichtenstein group underwent Lichtenstein hernia repair.

Group Type EXPERIMENTAL

Lichtenstein hernia repair.

Intervention Type PROCEDURE

The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.

Interventions

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Laparoscopic transabdominal preperitoneal hernia repair.

The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.

Intervention Type PROCEDURE

Lichtenstein hernia repair.

The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male patients aged 18 years and older.
* Patients with a definite diagnosis of unilateral primary inguinal hernia.
* Patients and their families were informed about the study protocol and agreed to participate in the study.

Exclusion Criteria

* Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
* Patients with previous history of lower abdominal surgery.
* Patients with contraindications to anaesthesia.
* Patients with contraindications to laparoscopic surgery.
* Failure to follow up patients as scheduled.
* Patients with abdominal infections.
* Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Second Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

Other Identifiers

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(2022) Annual Audit No. (175)

Identifier Type: -

Identifier Source: org_study_id

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