Inguinal HerniaNCT06240858
Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair
A study testing Laparoscopic transabdominal preperitoneal hernia repair. and Lichtenstein hernia repair. in people with Inguinal Hernia, run by Second Hospital of Jilin University at 1 site in China.
Trial summary
The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Laparoscopic transabdominal preperitoneal hernia repair. and Lichtenstein hernia repair.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 18 years and older.
- Patients with a definite diagnosis of unilateral primary inguinal hernia.
- Patients and their families were informed about the study protocol and agreed to participate in the study.
Who cannot join
- Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
- Patients with previous history of lower abdominal surgery.
- Patients with contraindications to anaesthesia.
- Patients with contraindications to laparoscopic surgery.
- Failure to follow up patients as scheduled.
- Patients with abdominal infections.
- Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair
The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.
Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.
Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.
- Conditions
- Inguinal Hernia
- Being tested
- Laparoscopic transabdominal preperitoneal hernia repair., Lichtenstein hernia repair.
- Keywords
- Self-gripping mesh, Laparoscopy, Herniorrhaphy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic transabdominal preperitoneal hernia repair.Procedure or surgery
The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.
Lichtenstein hernia repair.Procedure or surgery
The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| TAPP group | Experimental | The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair. Receives: Procedure: Laparoscopic transabdominal preperitoneal hernia repair. |
| Lichtenstein group | Experimental | The Lichtenstein group underwent Lichtenstein hernia repair. Receives: Procedure: Lichtenstein hernia repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe pain at 3 and 6 months after surgery.
Visual analogue scale (VAS) was used to score the postoperative pain at 3 and 6 months. The score ranges from 0 (no pain) to 10 (most severe pain).
Measured: 3 and 6 months after surgery.
Secondary outcomes (1)
Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.
Recurrence of inguinal hernia after surgery
Measured: 3 and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Mar 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240858
- Sponsor's protocol ID
- (2022) Annual Audit No. (175)
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing with other researchers is not planned at this time due to patient privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair
- ClinicalTrials.gov ID
- NCT06240858
- Acronym / sponsor ID
- (2022) Annual Audit No. (175)
- Conditions
- Inguinal Hernia
- Keywords
- Self-gripping mesh, Laparoscopy, Herniorrhaphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 5 Feb 2024 (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.
The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.
Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.
Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAPP group | Experimental | Procedure: Laparoscopic transabdominal preperitoneal hernia repair.The TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair. |
| Lichtenstein group | Experimental | Procedure: Lichtenstein hernia repair.The Lichtenstein group underwent Lichtenstein hernia repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients aged 18 years and older.
- Patients with a definite diagnosis of unilateral primary inguinal hernia.
- Patients and their families were informed about the study protocol and agreed to participate in the study.
Key exclusion criteria (7 listed)
- Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
- Patients with previous history of lower abdominal surgery.
- Patients with contraindications to anaesthesia.
- Patients with contraindications to laparoscopic surgery.
- Failure to follow up patients as scheduled.
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 |
|---|---|---|
| Laparoscopic transabdominal preperitoneal hernia repair.The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair. | Procedure or surgery | TAPP group |
| Lichtenstein hernia repair.The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair. | Procedure or surgery | Lichtenstein group |
Primary outcome
Incidence of moderate to severe pain at 3 and 6 months after surgery.
Time frame: 3 and 6 months after surgery.
Visual analogue scale (VAS) was used to score the postoperative pain at 3 and 6 months. The score ranges from 0 (no pain) to 10 (most severe pain).
1 secondary outcome
Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.
Time frame: 3 and 6 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. Data sharing with other researchers is not planned at this time due to patient privacy concerns.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic transabdominal preperitoneal hernia repair. and Lichtenstein hernia repair. in people with Inguinal Hernia, run by Second Hospital of Jilin University 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 7 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: finished, as of the sponsor's last update on 6 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate to severe pain at 3 and 6 months after surgery. (time frame: 3 and 6 months after surgery.). 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 6 Feb 2024.