NCT06885788

Brief Summary

This study aims to compare the clinical effects of uterine round ligament preservation versus resection in laparoscopic inguinal hernia repair in women.The primary outcomes included Time required for patient surgery.The secondary outcomes included Inguinal hernia recurrence,quality of life assessment,Indicators of postoperative recovery,, et al.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
466

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress67%
Sep 2024Mar 2027

Study Start

First participant enrolled

September 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

March 8, 2025

Last Update Submit

March 20, 2025

Conditions

Inguinal HerniaLaparoscopic SurgeryRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Time required for patient surgery

    Time required for patient surgery

    20-120minutes

Secondary Outcomes (2)

  • Inguinal hernia recurrence

    1 month, 3 months, 6 months,1year,2years,3years,6years

  • Quality of life assessment

    3 months,6months,1year,2years,3years,6years

Study Arms (8)

Patients with unilateral hernia who did not give birth,the uterine round ligament resection group

EXPERIMENTAL

Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with unilateral hernia who did not give birth)

Procedure: To remove the uterine uterine ligament

Patients with unilateral hernia who did not give birth,the uterine round ligament preservation group

NO INTERVENTION

Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with unilateral hernia who did not give birth)

Patients with unilateral hernia who have given birth,the uterine round ligament resection group

EXPERIMENTAL

Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with unilateral hernia who have given birth)

Procedure: To remove the uterine uterine ligament

Patients with unilateral hernia who have given birth,the uterine round ligament preservation group

NO INTERVENTION

Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with unilateral hernia who have given birth)

Patients with bilateral hernias who have given birth,the uterine round ligament resection group

EXPERIMENTAL

Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with bilateral hernias who have given birth)

Procedure: To remove the uterine uterine ligament

Patients with bilateral hernias who have given birth,the uterine round ligament preservation group

NO INTERVENTION

Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with bilateral hernias who have given birth)

Patients with bilateral hernia who did not give birth,the uterine round ligament resection group

EXPERIMENTAL

Both groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with bilateral hernia who did not give birth)

Procedure: To remove the uterine uterine ligament

Patients with bilateral hernia who did not give birth,the uterine round ligament preservation group

NO INTERVENTION

Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with bilateral hernia who did not give birth)

Interventions

To remove the uterine uterine ligamentPROCEDURE

Both groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed.

Patients with bilateral hernia who did not give birth,the uterine round ligament resection groupPatients with bilateral hernias who have given birth,the uterine round ligament resection groupPatients with unilateral hernia who did not give birth,the uterine round ligament resection groupPatients with unilateral hernia who have given birth,the uterine round ligament resection group

Eligibility Criteria

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

You may qualify if:

  • ►Age : Female patients over 18 years of age without a childbearing requirement
  • Diagnosis and basis : Female patients diagnosed with Unilateral inguinal hernia.
  • agreed to participate in this study and signed the informed consent form.

You may not qualify if:

  • ►Combined with severe heart, liver, kidney and other diseases.
  • pregnant or lactating women.
  • those with surgical contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 20, 2025

Study Start

September 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

CN(1)