Inguinal HerniaNCT06885788
Uterine Round Ligament Preservation Vs Resection in Laparoscopic Inguinal Hernia Repair in Women：A Multicenter,Stratified Randomized Controlled Trial
A study testing To remove the uterine uterine ligament in people with Inguinal Hernia and Laparoscopic Surgery, run by Nanchong Central Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Inguinal Hernia, Laparoscopic Surgery, Randomized Controlled Trial
- What is being tested?
- To remove the uterine uterine ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ►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.
Who cannot join
- ►Combined with severe heart, liver, kidney and other diseases.
- pregnant or lactating women.
- those with surgical contraindications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Yunhong Tian, PHD, 13508087719, drtianyunhong@126.com
About this study
Official title: 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.
- Being tested
- To remove the uterine uterine ligament
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To remove the uterine uterine ligamentProcedure or surgery
Both groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for patient surgery
Time required for patient surgery
Measured: 20-120minutes
Secondary outcomes (2)
Inguinal hernia recurrence
the recurrence of inguinal hernia
Measured: 1 month, 3 months, 6 months,1year,2years,3years,6years
Quality of life assessment
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.
Measured: 3 months,6months,1year,2years,3years,6years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start20 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885788
- Sponsor's protocol ID
- 2025006
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06885788
- Acronym / sponsor ID
- 2025006
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Patients with unilateral hernia who did not give birth,the uterine round ligament resection group | Experimental | Procedure: To remove the uterine uterine ligamentBoth groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with unilateral hernia who did not give birth) |
| 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 | Procedure: To remove the uterine uterine ligamentBoth groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with unilateral hernia who have given birth) |
| 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 | Procedure: To remove the uterine uterine ligamentBoth groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with bilateral hernias who have given birth) |
| 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 | Procedure: To remove the uterine uterine ligamentBoth groups underwent laparoscopic inguinal hernia repair,the resection group removed the uterine round ligament.(Patients with bilateral hernia who did not give birth) |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ►Age : Female patients over 18 years of age without a childbearing requirement
Key exclusion criteria (3 listed)
- ►Combined with severe heart, liver, kidney and other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To remove the uterine uterine ligamentBoth groups underwent laparoscopic inguinal hernia repair. The preservation group retained the uterine round ligament, while the resection group had it removed. | Procedure or surgery | Patients with bilateral hernia who did not give birth,the uterine round ligament resection group, Patients with bilateral hernias who have given birth,the uterine round ligament resection group, Patients with unilateral hernia who did not give birth,the uterine round ligament resection group, Patients with unilateral hernia who have given birth,the uterine round ligament resection group |
Primary outcome
Time required for patient surgery
Time frame: 20-120minutes
Time required for patient surgery
2 secondary outcomes
Inguinal hernia recurrence
Time frame: 1 month, 3 months, 6 months,1year,2years,3years,6years
Quality of life assessment
Time frame: 3 months,6months,1year,2years,3years,6years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To remove the uterine uterine ligament in people with Inguinal Hernia and Laparoscopic Surgery, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for patient surgery (time frame: 20-120minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.