Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair

By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under laparoscopy and provide evidence based medicine. with In the research process of the research group, a database on abdominal wall hernia will be established for the future Further study of hernia has laid a solid foundation.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Wall Hernia
• Intervention / Treatment: Procedure: Suture mode

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)
      • Contact: Bo Li, Prof.; Phone Number: 8615153169909; Email: libo197399@hotmail.com
      • Contact: Changjin Cui; Phone Number: 8615552802320; Email: 735213695@qq.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Conform to the diagnostic criteria of abdominal wall hernia;

  • Patients with general physical condition and can tolerate general anesthesia and laparoscopic surgery; ③ After explaining the situation to the patients and their families, they agreed to join the research group.

Exclusion Criteria:

• The diagnostic criteria of abdominal wall hernia were not met; ② Patients who have serious medical diseases and cannot tolerate laparoscopic surgery; ③ Patients with mental illness; ④ The judgment is affected by incomplete data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Small hernia ring group with continuous suture; Continuous suture of hernia ring with barbed wire<3cm	Procedure: Suture mode; Patients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture.
Active Comparator: Small hernia ring group with discontinuous full-thickness suture; Intermittent full layer suture to close hernia rings<3cm	Procedure: Suture mode; Patients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture.
Active Comparator: Large hernia ring group with continuous suture; Continuous suture of hernia ring with barbed wire>3cm	Procedure: Suture mode; Patients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture.
Active Comparator: Large hernia ring group with discontinuous full-thickness suture; Intermittent full layer suture to close hernia rings>3cm	Procedure: Suture mode; Patients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture.
Experimental: Large hernia ring group with continuous suture and discontinuous full-thickness suture; Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings>3cm	Procedure: Suture mode; Patients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recrudescence	Whether abdominal wall hernia recurred within 24 months	24 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to close the hernia ring	Time to close the hernia ring during operation	during operation
Bleeding volume	Intraoperative bleeding	during operation
Pain level	Postoperative pain level	immediately after the surgery
Gastrointestinal recovery time	Postoperative gastrointestinal recovery time	immediately after the surgery
Seroma	Whether there is seroma after operation	immediately after the surgery
Infected	Postoperative infection	immediately after the surgery

Collaborators and Investigators

• Sponsor: Bo Li

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: 2022006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No