Back to resultsClinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
Primary Purpose
Abdominal Wall Hernia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Suture mode
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Wall Hernia
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.
Sites / Locations
- The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
Small hernia ring group with continuous suture
Small hernia ring group with discontinuous full-thickness suture
Large hernia ring group with continuous suture
Large hernia ring group with discontinuous full-thickness suture
Large hernia ring group with continuous suture and discontinuous full-thickness suture
Arm Description
Continuous suture of hernia ring with barbed wire<3cm
Intermittent full layer suture to close hernia rings<3cm
Continuous suture of hernia ring with barbed wire>3cm
Intermittent full layer suture to close hernia rings>3cm
Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings>3cm
Outcomes
Primary Outcome Measures
recrudescence
Whether abdominal wall hernia recurred within 24 months
Secondary Outcome Measures
Time to close the hernia ring
Time to close the hernia ring during operation
Bleeding volume
Intraoperative bleeding
Pain level
Postoperative pain level
Gastrointestinal recovery time
Postoperative gastrointestinal recovery time
Seroma
Whether there is seroma after operation
Infected
Postoperative infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05661097
Brief Title
Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
Official Title
Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Wall Hernia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
random control trail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Small hernia ring group with continuous suture
Arm Type
Active Comparator
Arm Description
Continuous suture of hernia ring with barbed wire<3cm
Arm Title
Small hernia ring group with discontinuous full-thickness suture
Arm Type
Active Comparator
Arm Description
Intermittent full layer suture to close hernia rings<3cm
Arm Title
Large hernia ring group with continuous suture
Arm Type
Active Comparator
Arm Description
Continuous suture of hernia ring with barbed wire>3cm
Arm Title
Large hernia ring group with discontinuous full-thickness suture
Arm Type
Active Comparator
Arm Description
Intermittent full layer suture to close hernia rings>3cm
Arm Title
Large hernia ring group with continuous suture and discontinuous full-thickness suture
Arm Type
Experimental
Arm Description
Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings>3cm
Intervention Type
Procedure
Intervention Name(s)
Suture mode
Intervention Description
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.
Primary Outcome Measure Information:
Title
recrudescence
Description
Whether abdominal wall hernia recurred within 24 months
Time Frame
24 months after operation
Secondary Outcome Measure Information:
Title
Time to close the hernia ring
Description
Time to close the hernia ring during operation
Time Frame
during operation
Title
Bleeding volume
Description
Intraoperative bleeding
Time Frame
during operation
Title
Pain level
Description
Postoperative pain level
Time Frame
immediately after the surgery
Title
Gastrointestinal recovery time
Description
Postoperative gastrointestinal recovery time
Time Frame
immediately after the surgery
Title
Seroma
Description
Whether there is seroma after operation
Time Frame
immediately after the surgery
Title
Infected
Description
Postoperative infection
Time Frame
immediately after the surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Li, Prof.
Phone
8615153169909
Email
libo197399@hotmail.com
First Name & Middle Initial & Last Name & Degree
Changjin Cui
Phone
8615552802320
Email
735213695@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
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