A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia
1 other identifier
interventional
351
1 country
1
Brief Summary
This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedMay 21, 2025
May 1, 2025
2.1 years
June 17, 2023
May 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
recurrence
Check for recurrence by clinical examination or ultrasound at 6 months postoperatively
6 months
Postoperative pain
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 Outcomes (1)
postoperative complications
6 months
Study Arms (2)
3-point fixation group
EXPERIMENTALLightweight 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.
1-point fixation group
ACTIVE COMPARATORLightweight Mesh Fixation with 1-point Fixation in the back of rectus abdominis.
Interventions
Lightweight mesh fixation in 3 points
Eligibility Criteria
You may qualify if:
- Unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination.
You may not qualify if:
- Age below 18 years or older than 80. Direct hernia, femoral hernia, 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanchong Central Hospitallead
- Guang'an People's Hospitalcollaborator
- Pengan County People's Hospitalcollaborator
- People's Hospital of Yilong Countycollaborator
- Nanbu Hospital of County Chinese Medicinecollaborator
- Nanchong Jialing District People's Hospitalcollaborator
- Langzhong People's Hospitalcollaborator
- Langzhong Traditional Chinese Medicine Hospitalcollaborator
Study Sites (1)
Yunhong Tian
Nanchong, Sichuan, 637000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastrointestinal, Colorectal and Hernia Surgery
Study Record Dates
First Submitted
June 17, 2023
First Posted
July 3, 2023
Study Start
January 1, 2023
Primary Completion
January 30, 2025
Study Completion
January 30, 2025
Last Updated
May 21, 2025
Record last verified: 2025-05