- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06314152
3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
March 19, 2024 updated by: Nanchong Central Hospital
A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia.
The main outcome include seroma, chronic pain, recurrence, et al.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
337
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Nanchong, Sichuan, China, 637000
- Recruiting
- Yunhong Tian
-
Contact:
- Yunhong Tian, PHD
- Phone Number: 13508087719
- Email: drtianyunhong@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Unilateral inguinal hernia according to preoperative physical examination and imaging examination.
The inclusion criteria were as follows: primary indirect inguinal hernia or direct hernia.
Exclusion Criteria:
- Age below 18 years or older than 80. recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias.
Patients not suitable for general anesthesia. Patients requiring open surgery; patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3-point fixation group
During laparoscopic transabdominal preperitoneal inguinal hernia repair, lightweight Mesh Fixation with 3-point Fixation.
First fixation is in cooper ligament.
Second fixation is in the back of rectus abdominis.
Third fixation is in the later of tractus iliopubicus.
|
Lightweight mesh fixation in 3 points
|
Active Comparator: 1-point fixation group
During laparoscopic transabdominal preperitoneal inguinal hernia repair, lightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis.
|
Lightweight mesh fixation in 3 points
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recurrence
Time Frame: 1 month,3 months,6 months and 12 months after surgery
|
Hernia recurrenceFollow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.
|
1 month,3 months,6 months and 12 months after surgery
|
Rate of postoperative pain
Time Frame: 6 months
|
The visual analog scale (VAS) was adopted for pain evaluation 2 days, 3 months, and 6 months postoperatively.
The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of postoperative complications
Time Frame: 6 months
|
Including infection, seroma, hematoma
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Estimated)
October 10, 2024
Study Completion (Estimated)
October 10, 2024
Study Registration Dates
First Submitted
March 10, 2024
First Submitted That Met QC Criteria
March 10, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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