Uterine Round Ligament Preservation Vs Resection in Laparoscopic Inguinal Hernia Repair in Women：A Multicenter,Stratified Randomized Controlled Trial

March 20, 2025 updated by: Nanchong Central Hospital

Comparative Study on the Effect of Uterine Round Ligament Preservation Vs Resection in Laparoscopic Inguinal Hernia Repair in Women： a Multicenter,Stratified Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

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

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Recruiting
        • Nanchong Central Hospital
        • Contact:

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:

  • ►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.

Exclusion Criteria:

  • ►Combined with severe heart, liver, kidney and other diseases.

    • pregnant or lactating women.
    • those with surgical contraindications.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with unilateral hernia who did not give birth,the uterine round ligament resection group
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
Both groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed.
No Intervention: Patients with unilateral hernia who did not give birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with unilateral hernia who did not give birth)
Experimental: Patients with unilateral hernia who have given birth,the uterine round ligament resection group
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
Both groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed.
No Intervention: Patients with unilateral hernia who have given birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with unilateral hernia who have given birth)
Experimental: Patients with bilateral hernias who have given birth,the uterine round ligament resection group
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
Both groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed.
No Intervention: Patients with bilateral hernias who have given birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with bilateral hernias who have given birth)
Experimental: Patients with bilateral hernia who did not give birth,the uterine round ligament resection group
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
Both groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed.
No Intervention: Patients with bilateral hernia who did not give birth,the uterine round ligament preservation group
Both groups underwent laparoscopic inguinal hernia repair,the preservation group retained the uterine round ligament.(Patients with bilateral hernia who did not give birth)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for patient surgery
Time Frame: 20-120minutes
Time required for patient surgery
20-120minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inguinal hernia recurrence
Time Frame: 1 month, 3 months, 6 months,1year,2years,3years,6years
the recurrence of inguinal hernia
1 month, 3 months, 6 months,1year,2years,3years,6years
Quality of life assessment
Time Frame: 3 months,6months,1year,2years,3years,6years
Quality of life assessment:The international general quality of life scale (such as SF - 36, etc.) is used to evaluate the quality of life of patients at 3 months , 6months,1year,2years,3years and 6years after surgery.
3 months,6months,1year,2years,3years,6years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanchong Central Hospital

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)

September 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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