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CompletedNCT06061068Updated May 21, 2025

Hernia Belt in Laparoscopic Inguinal Hernia Repair

An interventional study of Hernia belt compression in Hernia, Inguinal, Recurrence and Seroma Following Procedure, sponsored by Nanchong Central Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by Nanchong Central Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
678
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.

Read the detailed description

Some scholars believe that the use of hernia belts to compress the inguinal region reduces postoperative complications. According to the International Guidelines for the Management of Inguinal Hernia in Adults (2018) interpretation, the incidence of seroma after inguinal hernia repair ranges from 0.5% to 2.2%. However,there is no consensus among different research organizations and clinical staff on the use of hernia belts after laparoscopic inguinal hernia repair. In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.

02

Conditions studied

  • Hernia, Inguinal
  • Recurrence
  • Seroma Following Procedure
  • Pain, Postoperative
  • Quality of Life

Keywords

  • Laparoscopic inguinal hernia repair
  • Hernia belt
  • Hernia recurrence
  • Seroma Following Procedure
  • Pain, Postoperative
  • Quality of Life
03

In context

Hernia, Inguinal

543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.

This study's enrollment of 678 is above the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Nanchong Central Hospital is the lead sponsor of 20 studies on the registry; 13 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
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

  1. 18 years or order.
  2. Primary unilateral oblique inguinal hernia, direct hernia, femoral hernia.
  3. Qualified for laparoscopic Transabdominal preperitoneal approach(TAPP) or Totally extraperitoneal(TEP).
  4. Eligible to tolerate general anesthesia.

Exclusion criteria

Exclusion Criteria:

  1. Incarcerated hernia, recurrent hernia and other types of hernia.
  2. Patients presenting for obvious to surgery.
  3. Need for an open inguinal hernia repair.
  4. Difficult to follow-up or communication.
  5. Patients who are unable to give .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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05

Study design

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

Study arms

  • Experimental
    Hernia belt compressing group

    Patients were given hernia belt compression of the inguinal region after laparoscopic inguinal hernia repair surgery in the operating room. The silicone pad of the hernia belt was placed in the inguinal region of the surgical side for compression for a period of 2 weeks.

    Procedure: Hernia belt compression

  • No intervention
    No hernia belt compressing group

    Patients were should not have the intervention "Hernia belt compression" .

Interventions

  • ProcedureHernia belt compression

    Use the hernia belt to compress the inguinal region

06

What researchers measure

Primary outcomes

  1. Hernia recurrence

    Follow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.

    Time frame: 1 month,3 months,6 months and 12 months after surgery.

  2. Postoperative complications

    Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone.

    Time frame: Within 3 months after surgery.

  3. Pain score

    The visual analog scale (VAS) was adopted for pain evaluation preoperative,1 day, 7 days, 1 months and 3 months postoperatively.The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.Higher scores mean a worse outcome.

    Time frame: 1 day,7 days,1 month and 3 months after surgery.

  4. Health-related quality of life

    The 36-item short-form health survey(SF-36) was adopted for Health-related quality of life 1 day, 7 days, 1 months and 3 months postoperatively. SF-36 consists of 36 articles, including 8 areas of physical function, physical role, physical pain, general health status, vitality, social function, emotional role and mental health.

    Time frame: 1 day,7 days,1 month and 3 months after surgery.

07

Study locations

1 site
  • Yunhong Tian
    Nanchong, Sichuan 637000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06061068
Lead sponsor
Nanchong Central Hospital
Collaborators
Guang'an People's Hospital, Pengan County People's Hospital, People's Hospital of Yilong County, Nanbu Hospital of County Chinese Medicine
Responsible party
Yunhong Tian (Director of Gastrointestinal, Colorectal and Hernia Surgery, Nanchong Central Hospital) — Principal investigator
First posted
Sep 29, 2023
Start date
Jul 17, 2023
Primary completion
May 17, 2025
Completion
May 17, 2025
Last update
May 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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