Recurrent Inguinal HerniaNCT06604572
TAPP and Open Repair for Recurrent Inguinal Hernia
A study testing Transabdominal preperitoneal approach in people with Recurrent Inguinal Hernia, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
The objective of this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recurrent Inguinal Hernia
- What is being tested?
- Transabdominal preperitoneal approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 28 Oct 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- the diagnosis of recurrent inguinal hernia made by ultrasound or computed tomography (CT) during the present visit
- ability to tolerate general anesthesia and local anesthesia surgery
- all patients and their families agreed to participate in this study and sign relevant informed consent.
Who cannot join
- patch infection during the first surgery
- multiple (≥ 2) relapses
- inability to cooperate to complete follow-up after surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Clinical study of recurrent inguinal hernia
Kunming, Yunnan, 650000
Weiming Li, 13114225597, liweiming49@163.com
About this study
Official title: Clinical Study of Transabdominal Preperitoneal Approach Versus Open Tension-free Hernia Repair for the Treatment of Recurrent Inguinal Hernia
The objective of this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias.
Read the detailed description
The patients were randomly allocated to the TAPP group and the open tension-free repair group. We recorded the general situation, operation time, and intraoperative complications; postoperative visual analogue pain scale (VAS) scores at 24 and 48 h; and the incidence of complications such as seroma, chronic pain, inguinal numbness, foreign body sensation, and recurrence at 1 week, 1 month, 3 months, 6 months and 1 year after surgery. These indicators were compared between the two groups of patients.
- Conditions
- Recurrent Inguinal Hernia
- Being tested
- Transabdominal preperitoneal approach
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal preperitoneal approachProcedure or surgery
Also called Open tension-free hernia repair
The enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal preperitoneal approach surgery group | Experimental | The enrolled patients were treated with Transabdominal preperitoneal approach Receives: Procedure: Transabdominal preperitoneal approach |
| Open tension-free hernia repair group | Other | The enrolled patients were treated with open tension-free hernia repair Receives: Procedure: Transabdominal preperitoneal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperation pain
Postoperative pain was monitored using the VAS pain scoring system (0-10 points) and recorded at 24 and 48 h. Patients with groin pain for more than 3 months were recorded during follow-up.
Measured: 24 hours, 48 hours, three months after surgery
Secondary outcomes (8)
Numbness and foreign body sensation
The occurrence of groin numbness and foreign body sensation after operation was recorded
Measured: The mean follow-up time was 10 months after surgery
Operating time
Record the patient\'s operating time
Measured: During surgery
Hemorrhage
The amount of surgical bleeding was recorded
Measured: During surgery
Urinary retention
Urinary retention was observed and recorded after operation
Measured: One week after surgery
Seroma
The occurrence of postoperative seroma was observed and recorded
Measured: The mean follow-up time was 2 weeks after surgery
Recurrence
The recurrence of patients after operation was observed and recorded
Measured: The mean follow-up time was 1 year after surgery
Fever
The postoperative fever was observed and recorded
Measured: One week after surgery
Length of hospital stay
The patient\'s length of stay was recorded
Measured: Within a week of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion28 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Li, The Second Affiliated Hospital of Kunming Medical University
- Investigators
- Weiming Li, doctor, Principal investigator, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604572
- Sponsor's protocol ID
- PJ-2022-85
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Transabdominal Preperitoneal Approach Versus Open Tension-free Hernia Repair for the Treatment of Recurrent Inguinal Hernia
- ClinicalTrials.gov ID
- NCT06604572
- Acronym / sponsor ID
- PJ-2022-85
- Conditions
- Recurrent Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 28 Oct 2025 (estimated)
- First posted
- 19 Sep 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 objective of this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias.
Detailed description
The patients were randomly allocated to the TAPP group and the open tension-free repair group. We recorded the general situation, operation time, and intraoperative complications; postoperative visual analogue pain scale (VAS) scores at 24 and 48 h; and the incidence of complications such as seroma, chronic pain, inguinal numbness, foreign body sensation, and recurrence at 1 week, 1 month, 3 months, 6 months and 1 year after surgery. These indicators were compared between the two groups of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transabdominal preperitoneal approach surgery group | Experimental | Procedure: Transabdominal preperitoneal approachThe enrolled patients were treated with Transabdominal preperitoneal approach |
| Open tension-free hernia repair group | Other | Procedure: Transabdominal preperitoneal approachThe enrolled patients were treated with open tension-free hernia repair |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- the diagnosis of recurrent inguinal hernia made by ultrasound or computed tomography (CT) during the present visit
- ability to tolerate general anesthesia and local anesthesia surgery
- all patients and their families agreed to participate in this study and sign relevant informed consent.
Key exclusion criteria (3 listed)
- patch infection during the first surgery
- multiple (≥ 2) relapses
- inability to cooperate to complete follow-up after surgery
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 |
|---|---|---|
| Transabdominal preperitoneal approachAlso: Open tension-free hernia repairThe enrolled patients underwent either open tension-free hernia repair or Transabdominal preperitoneal approach | Procedure or surgery | Open tension-free hernia repair group, Transabdominal preperitoneal approach surgery group |
Primary outcome
Postoperation pain
Time frame: 24 hours, 48 hours, three months after surgery
Postoperative pain was monitored using the VAS pain scoring system (0-10 points) and recorded at 24 and 48 h. Patients with groin pain for more than 3 months were recorded during follow-up.
8 secondary outcomes
Numbness and foreign body sensation
Time frame: The mean follow-up time was 10 months after surgery
Operating time
Time frame: During surgery
Hemorrhage
Time frame: During surgery
Urinary retention
Time frame: One week after surgery
Seroma
Time frame: The mean follow-up time was 2 weeks after surgery
Recurrence
Time frame: The mean follow-up time was 1 year after surgery
Fever
Time frame: One week after surgery
Length of hospital stay
Time frame: Within a week of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Weiming Li, doctor principal investigator
The Second Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal preperitoneal approach in people with Recurrent Inguinal Hernia, run by The Second Affiliated Hospital of Kunming Medical 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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiming Li (13114225597, liweiming49@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperation pain (time frame: 24 hours, 48 hours, three 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 19 Sep 2024.