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

NCT05661097 | Unknown

• 1 other identifier: 2022006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Wall Hernia

Outcome Measures

Primary Outcomes (1)

• recrudescence

  Whether abdominal wall hernia recurred within 24 months

  24 months after operation

Secondary Outcomes (6)

• Time to close the hernia ring

  during operation

• Bleeding volume

  during operation

• Pain level

  immediately after the surgery

• Gastrointestinal recovery time

  immediately after the surgery

• Seroma

  immediately after the surgery

Study Arms (5)

Small hernia ring group with continuous suture

ACTIVE COMPARATOR

Continuous suture of hernia ring with barbed wire\<3cm

Procedure: Suture mode

Small hernia ring group with discontinuous full-thickness suture

ACTIVE COMPARATOR

Intermittent full layer suture to close hernia rings\<3cm

Procedure: Suture mode

Large hernia ring group with continuous suture

ACTIVE COMPARATOR

Continuous suture of hernia ring with barbed wire\>3cm

Procedure: Suture mode

Large hernia ring group with discontinuous full-thickness suture

ACTIVE COMPARATOR

Intermittent full layer suture to close hernia rings\>3cm

Procedure: Suture mode

Large hernia ring group with continuous suture and discontinuous full-thickness suture

EXPERIMENTAL

Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings\>3cm

Procedure: Suture mode

Interventions

Suture mode PROCEDURE

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.

Large hernia ring group with continuous suture; Large hernia ring group with continuous suture and discontinuous full-thickness suture; Large hernia ring group with discontinuous full-thickness suture; Small hernia ring group with continuous suture; Small hernia ring group with discontinuous full-thickness suture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bo Li: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: random control trail

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 22, 2022
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)