TAPP and Open Repair for Recurrent Inguinal Hernia

NCT ID: NCT06604572

Last Updated: 2024-09-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-10-28

Brief Summary

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The objective of this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias.

Detailed Description

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The patients were randomly allocated to the TAPP group and the open tension-free repair group. We recorded the general situation, operation time, and intraoperative complications; postoperative visual analogue pain scale (VAS) scores at 24 and 48 h; and the incidence of complications such as seroma, chronic pain, inguinal numbness, foreign body sensation, and recurrence at 1 week, 1 month, 3 months, 6 months and 1 year after surgery. These indicators were compared between the two groups of patients.

Conditions

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Recurrent Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Transabdominal preperitoneal approach surgery group

The enrolled patients were treated with Transabdominal preperitoneal approach

Group Type EXPERIMENTAL

Transabdominal preperitoneal approach

Intervention Type PROCEDURE

The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach

Open tension-free hernia repair group

The enrolled patients were treated with open tension-free hernia repair

Group Type OTHER

Transabdominal preperitoneal approach

Intervention Type PROCEDURE

The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach

Interventions

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Transabdominal preperitoneal approach

The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach

Intervention Type PROCEDURE

Other Intervention Names

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Open tension-free hernia repair

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* the diagnosis of recurrent inguinal hernia made by ultrasound or computed tomography (CT) during the present visit
* ability to tolerate general anesthesia and local anesthesia surgery
* all patients and their families agreed to participate in this study and sign relevant informed consent.

Exclusion Criteria

* patch infection during the first surgery
* multiple (≥ 2) relapses
* inability to cooperate to complete follow-up after surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weiming Li

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiming Li, doctor

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Kunming Medical University

Locations

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Clinical study of recurrent inguinal hernia

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiming Li

Role: CONTACT

13114225597

Facility Contacts

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Weiming Li

Role: primary

13114225597

Other Identifiers

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PJ-2022-85

Identifier Type: -

Identifier Source: org_study_id

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