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

Sponsor
Bo Li (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05661097
Collaborator
(none)
100
1
5
36
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Suture mode
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
random control trailrandom control trail
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. recrudescence [24 months after operation]

    Whether abdominal wall hernia recurred within 24 months

Secondary Outcome Measures

  1. Time to close the hernia ring [during operation]

    Time to close the hernia ring during operation

  2. Bleeding volume [during operation]

    Intraoperative bleeding

  3. Pain level [immediately after the surgery]

    Postoperative pain level

  4. Gastrointestinal recovery time [immediately after the surgery]

    Postoperative gastrointestinal recovery time

  5. Seroma [immediately after the surgery]

    Whether there is seroma after operation

  6. Infected [immediately after the surgery]

    Postoperative infection

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital) Jinan Shandong China 250000

Sponsors and Collaborators

  • Bo Li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bo Li, Chief physician, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT05661097
Other Study ID Numbers:
  • 2022006
First Posted:
Dec 22, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 22, 2022