TAPP and Open Repair for Recurrent Inguinal Hernia

Clinical Study of Transabdominal Preperitoneal Approach Versus Open Tension-free Hernia Repair for the Treatment of Recurrent Inguinal Hernia

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Inguinal Hernia
• Intervention / Treatment: Procedure: Transabdominal preperitoneal approach

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: weiming Li; Phone Number: 13114225597; Email: liweiming49@163.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Recruiting
      • Clinical study of recurrent inguinal hernia
      • Contact: weiming Li; Phone Number: 13114225597; Email: liweiming49@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transabdominal preperitoneal approach surgery group; The enrolled patients were treated with Transabdominal preperitoneal approach	Procedure: Transabdominal preperitoneal approach; The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach; Other Names: Open tension-free hernia repair
Other: Open tension-free hernia repair group; The enrolled patients were treated with open tension-free hernia repair	Procedure: Transabdominal preperitoneal approach; The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach; Other Names: Open tension-free hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Kunming Medical University
• Investigators: Principal Investigator: Weiming Li, doctor, The Second Affiliated Hospital of Kunming Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 28, 2025

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Recurrence
• Other Study ID Numbers: PJ-2022-85

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No