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A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia

A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP Surgery for Patients With Gilbert Type III Inguinal Hernia: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05929378
Enrollment
351
Registered
2023-07-03
Start date
2023-01-01
Completion date
2025-01-30
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Hematoma, Hernia, Inguinal, Infections, Recurrence, Seroma

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.

Interventions

PROCEDURELightweight mesh fixation

Lightweight mesh fixation in 3 points

Sponsors

Guang'an People's Hospital
CollaboratorUNKNOWN
Pengan County People's Hospital
CollaboratorOTHER
People's Hospital of Yilong County
CollaboratorUNKNOWN
Nanbu Hospital of County Chinese Medicine
CollaboratorOTHER
Nanchong Jialing District People's Hospital
CollaboratorUNKNOWN
Langzhong People's Hospital
CollaboratorUNKNOWN
Langzhong Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Nanchong Central Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination. The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
recurrence6 monthsCheck for recurrence by clinical examination or ultrasound at 6 months postoperatively
Postoperative pain6 monthsThe 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.

Secondary

MeasureTime frameDescription
postoperative complications6 monthsIncluding infection, seroma, hematoma

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026