RecruitingNCT05661097Updated Sep 1, 2023

Clinical Study of Hernia Ring Closure Method in Laparoscopic Abdominal Wall Hernia Repair

An interventional study of Suture mode in Abdominal Wall Hernia, sponsored by Bo Li. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Bo Li · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
Started Mar 2023; still recruiting 3 years 8 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Sex: All

Study 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 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 studied

Abdominal Wall Hernia

Browse trials for

Hernia, Abdominal 82

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

This is the only study on the registry with Bo Li as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Active comparator
Small hernia ring group with continuous suture
Continuous suture of hernia ring with barbed wire\<3cm
Procedure: Suture mode
Active comparator
Small hernia ring group with discontinuous full-thickness suture
Intermittent full layer suture to close hernia rings\<3cm
Procedure: Suture mode
Active comparator
Large hernia ring group with continuous suture
Continuous suture of hernia ring with barbed wire\>3cm
Procedure: Suture mode
Active comparator
Large hernia ring group with discontinuous full-thickness suture
Intermittent full layer suture to close hernia rings\>3cm
Procedure: Suture mode
Experimental
Large hernia ring group with continuous suture and discontinuous full-thickness suture
Continuous suture with barbed thread and discontinuous full-thickness suture to close hernia rings\>3cm
Procedure: Suture mode

Interventions

ProcedureSuture mode
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.

What researchers measure

Primary outcomes

recrudescence
Whether abdominal wall hernia recurred within 24 months
Time frame: 24 months after operation

Secondary outcomes

Time to close the hernia ring
Time to close the hernia ring during operation
Time frame: during operation
Bleeding volume
Intraoperative bleeding
Time frame: during operation
Pain level
Postoperative pain level
Time frame: immediately after the surgery
Gastrointestinal recovery time
Postoperative gastrointestinal recovery time
Time frame: immediately after the surgery
Seroma
Whether there is seroma after operation
Time frame: immediately after the surgery
Infected
Postoperative infection
Time frame: immediately after the surgery

Study locations

1 of 1 sites recruiting

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfo Mountain Hospital)
Jinan, Shandong 250000, China
Recruiting
- Bo Li, Prof. · Contact · libo197399@hotmail.com · 8615153169909
- Changjin Cui · Contact · 735213695@qq.com · 8615552802320
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Jan 2025, 22 months after the start.

Of 31 interventional studies with no phase under Hernia, Abdominal, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's planned 22 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 7, 2022
First posted: Dec 22, 2022
StartActual: Mar 1, 2023
Primary completionEst.: Jan 1, 2025
CompletionEst.: Jan 1, 2026
Last update: Sep 1, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05661097
Lead sponsor: Bo Li
Responsible party: Bo Li (Chief physician, Qianfoshan Hospital) — Sponsor-investigator
First posted: Dec 22, 2022
Start date: Mar 1, 2023
Primary completion: Jan 1, 2025 (estimated)
Completion: Jan 1, 2026 (estimated)
Last update: Sep 1, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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