TAPP and Open Repair for Recurrent Inguinal Hernia

Not Applicable

Recruiting

• Conditions: Recurrent Inguinal Hernia
• Interventions: Procedure: Transabdominal preperitoneal approach

• Registration Number: NCT06604572
• Lead Sponsor: The Second Affiliated Hospital of Kunming Medical University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transabdominal preperitoneal approach surgery group	Transabdominal preperitoneal approach	The enrolled patients were treated with Transabdominal preperitoneal approach
Open tension-free hernia repair group	Transabdominal preperitoneal approach	The enrolled patients were treated with open tension-free hernia repair

Primary Outcome Measures

Name	Time	Method
Postoperation pain	24 hours, 48 hours, three months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Numbness and foreign body sensation	The mean follow-up time was 10 months after surgery	The occurrence of groin numbness and foreign body sensation after operation was recorded
Operating time	During surgery	Record the patient\'s operating time
Hemorrhage	During surgery	The amount of surgical bleeding was recorded
Urinary retention	One week after surgery	Urinary retention was observed and recorded after operation
Seroma	The mean follow-up time was 2 weeks after surgery	The occurrence of postoperative seroma was observed and recorded
Recurrence	The mean follow-up time was 1 year after surgery	The recurrence of patients after operation was observed and recorded
Fever	One week after surgery	The postoperative fever was observed and recorded
Length of hospital stay	Within a week of surgery	The patient\'s length of stay was recorded

Trial Locations

Locations (1)

Clinical study of recurrent inguinal hernia; 🇨🇳 Kunming, Yunnan, China