TAPP and Open Repair for Recurrent Inguinal Hernia

NCT06604572 | Recruiting

• 1 other identifier: PJ-2022-85
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• Postoperation pain

  Postoperative pain was monitored using the VAS pain scoring system (0-10 points) and recorded at 24 and 48 h. Patients with groin pain for more than 3 months were recorded during follow-up.

  24 hours, 48 hours, three months after surgery

Secondary Outcomes (8)

• Numbness and foreign body sensation

  The mean follow-up time was 10 months after surgery

• Operating time

  During surgery

• Hemorrhage

  During surgery

• Urinary retention

  One week after surgery

• Seroma

  The mean follow-up time was 2 weeks after surgery

Study Arms (2)

Transabdominal preperitoneal approach surgery group

EXPERIMENTAL

The enrolled patients were treated with Transabdominal preperitoneal approach

Procedure: Transabdominal preperitoneal approach

Open tension-free hernia repair group

OTHER

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

Procedure: Transabdominal preperitoneal approach

Interventions

Transabdominal preperitoneal approach PROCEDURE

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

Also known as: Open tension-free hernia repair

Open tension-free hernia repair group; Transabdominal preperitoneal approach surgery group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Clinical study of recurrent inguinal hernia

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Weiming Li, doctor

  The Second Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Li

CONTACT

13114225597; liweiming49@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 28, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)