Abdominal Wall HerniaNCT05661097
Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
A study testing Suture mode in people with Abdominal Wall Hernia, run by Bo Li at 1 site in China.
Trial summary
By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Wall Hernia
- What is being tested?
- Suture mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Conform to the diagnostic criteria of abdominal wall hernia;
- Patients with general physical condition and can tolerate general anesthesia and laparoscopic surgery; ③ After explaining the situation to the patients and their families, they agreed to join the research group.
Who cannot join
- The diagnostic criteria of abdominal wall hernia were not met; ② Patients who have serious medical diseases and cannot tolerate laparoscopic surgery; ③ Patients with mental illness; ④ The judgment is affected by incomplete data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)
Jinan, Shandong, 250000
Bo Li, Prof., 8615153169909, libo197399@hotmail.com
Changjin Cui, 8615552802320, 735213695@qq.com
About this study
By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under laparoscopy and provide evidence based medicine. with In the research process of the research group, a database on abdominal wall hernia will be established for the future Further study of hernia has laid a solid foundation.
- Conditions
- Abdominal Wall Hernia
- Being tested
- Suture mode
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture modeProcedure or surgery
Patients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture.
| Study group | Role | What they receive |
|---|---|---|
| Small hernia ring group with continuous suture | Active comparator | Continuous suture of hernia ring with barbed wire<3cm Receives: Procedure: Suture mode |
| Small hernia ring group with discontinuous full-thickness suture | Active comparator | Intermittent full layer suture to close hernia rings<3cm Receives: Procedure: Suture mode |
| Large hernia ring group with continuous suture | Active comparator | Continuous suture of hernia ring with barbed wire>3cm Receives: Procedure: Suture mode |
| Large hernia ring group with discontinuous full-thickness suture | Active comparator | Intermittent full layer suture to close hernia rings>3cm Receives: Procedure: Suture mode |
| Large hernia ring group with continuous suture and discontinuous full-thickness suture | Experimental | Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings>3cm Receives: Procedure: Suture mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
recrudescence
Whether abdominal wall hernia recurred within 24 months
Measured: 24 months after operation
Secondary outcomes (6)
Time to close the hernia ring
Time to close the hernia ring during operation
Measured: during operation
Bleeding volume
Intraoperative bleeding
Measured: during operation
Pain level
Postoperative pain level
Measured: immediately after the surgery
Gastrointestinal recovery time
Postoperative gastrointestinal recovery time
Measured: immediately after the surgery
Seroma
Whether there is seroma after operation
Measured: immediately after the surgery
Infected
Postoperative infection
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall 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
- Model description
- random control trail
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Li, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661097
- Sponsor's protocol ID
- 2022006
- Status last verified
- Aug 2023
- First submitted
- 7 Dec 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair
- ClinicalTrials.gov ID
- NCT05661097
- Acronym / sponsor ID
- 2022006
- Conditions
- Abdominal Wall Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bo LiUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 22 Dec 2022 (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.
By comparing the time of closing the hernia ring, the degree of pain, and the recovery of gastrointestinal tract in different groups Intervening, infection, recurrence and medical cost, to find out whether patients with abdominal wall hernia have different hernias It is the best way to close the hernia ring under laparoscopy and provide evidence based medicine. with In the research process of the research group, a database on abdominal wall hernia will be established for the future Further study of hernia has laid a solid foundation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- random control trail
| Arm | Type | Receives |
|---|---|---|
| Small hernia ring group with continuous suture | Active comparator | Procedure: Suture modeContinuous suture of hernia ring with barbed wire<3cm |
| Small hernia ring group with discontinuous full-thickness suture | Active comparator | Procedure: Suture modeIntermittent full layer suture to close hernia rings<3cm |
| Large hernia ring group with continuous suture | Active comparator | Procedure: Suture modeContinuous suture of hernia ring with barbed wire>3cm |
| Large hernia ring group with discontinuous full-thickness suture | Active comparator | Procedure: Suture modeIntermittent full layer suture to close hernia rings>3cm |
| Large hernia ring group with continuous suture and discontinuous full-thickness suture | Experimental | Procedure: Suture modeContinuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings>3cm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Conform to the diagnostic criteria of abdominal wall hernia;
Key exclusion criteria (1 listed)
- The diagnostic criteria of abdominal wall hernia were not met; ② Patients who have serious medical diseases and cannot tolerate laparoscopic surgery; ③ Patients with mental illness; ④ The judgment is affected by incomplete data.
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 |
|---|---|---|
| Suture modePatients in the small hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture by hernia hook needle.Patients in the large hernia ring group received continuous suture with barbed wire according to simple random method Closure mode, intermittent full layer suture with hernia hook needle, continuous suture with barbed wire+hernia Intermittent full layer crochet suture. | Procedure or surgery | Large hernia ring group with continuous suture, Large hernia ring group with continuous suture and discontinuous full-thickness suture, Large hernia ring group with discontinuous full-thickness suture, Small hernia ring group with continuous suture, Small hernia ring group with discontinuous full-thickness suture |
Primary outcome
recrudescence
Time frame: 24 months after operation
Whether abdominal wall hernia recurred within 24 months
6 secondary outcomes
Time to close the hernia ring
Time frame: during operation
Bleeding volume
Time frame: during operation
Pain level
Time frame: immediately after the surgery
Gastrointestinal recovery time
Time frame: immediately after the surgery
Seroma
Time frame: immediately after the surgery
Infected
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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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 First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)
Jinan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture mode in people with Abdominal Wall Hernia, run by Bo Li 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 2 inclusion and 1 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 1 Sep 2023. 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?
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?
recrudescence (time frame: 24 months after operation). 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 1 Sep 2023.