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

NCT ID: NCT05661097

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Small hernia ring group with continuous suture

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

Group Type: ACTIVE_COMPARATOR

Suture mode

Intervention Type: 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.

Small hernia ring group with discontinuous full-thickness suture

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

Group Type: ACTIVE_COMPARATOR

Suture mode

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Suture mode

Intervention Type: 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 discontinuous full-thickness suture

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

Group Type: ACTIVE_COMPARATOR

Suture mode

Intervention Type: 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 and discontinuous full-thickness suture

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

Group Type: EXPERIMENTAL

Suture mode

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bo Li

OTHER

Sponsor Role: lead

Responsible Party

Bo Li

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Bo Li, Prof.

Role: primary

libo197399@hotmail.com

8615153169909

Changjin Cui

Role: backup

735213695@qq.com

8615552802320

Other Identifiers

2022006

Identifier Type: -

Identifier Source: org_study_id