NCT06314152

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 inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

March 10, 2024

Last Update Submit

April 6, 2026

Conditions

Inguinal HerniaChronic PainSeromaRecurrentInfectionsHematoma

Outcome Measures

Primary Outcomes (2)

  • Rate of postoperative pain

    The visual analog scale (VAS) was adopted for pain evaluation 1 day, 7 days, 1 month, 3 months, 6 months and 12 months postoperatively. The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.

    12 months

  • Rate of recurrence

    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

Secondary Outcomes (1)

  • Rate of postoperative complications

    12 months

Study Arms (2)

3-point fixation group

EXPERIMENTAL

Using 3-0 absorbable sutures, the mesh was secured at three key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, and (3) the lateral edge of the iliopubic tract.

Procedure: Lightweight mesh fixation in 3 points or 1 point

1-point fixation group

ACTIVE COMPARATOR

Using 3-0 absorbable sutures, the mesh was secured at one of the following key anatomical landmarks: (1) the posterior rectus sheath medially, (2) the pubic pectineal ligament (Cooper's ligament) inferiorly, or (3) the lateral edge of the iliopubic tract. The fixation site was selected based on the most prominent anatomical landmark, with preference given to the pubic pectineal ligament (Cooper's ligament) or the lateral edge of the iliopubic tract.

Procedure: Lightweight mesh fixation in 3 points or 1 point

Interventions

Lightweight mesh fixation in 3 points or 1 pointPROCEDURE

Lightweight mesh fixation in 3 points

1-point fixation group3-point fixation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral inguinal hernia according to preoperative physical examination and imaging examination.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunhong Tian

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Hernia, InguinalChronic PainSeromaRecurrenceInfectionsHematoma

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsInflammationPathologic ProcessesDisease AttributesHemorrhage

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
SPONSOR

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 15, 2024

Study Start

January 1, 2023

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

CN(1)