Hernia Belt in Laparoscopic Inguinal Hernia Repair

May 16, 2025 updated by: Yunhong Tian, Nanchong Central Hospital

The Effect of Hernia Belt on Postoperative Complications and Quality of Life for Patients Who Underwent Laparoscopic Inguinal Hernia Repair:a Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
678

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Yunhong Tian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  1. Incarcerated hernia, recurrent hernia and other types of hernia.
  2. Patients presenting for obvious contraindications to surgery.
  3. Need for an open inguinal hernia repair.
  4. Difficult to follow-up or communication.
  5. Patients who are unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Use the hernia belt to compress the inguinal region
No Intervention: No hernia belt compressing group
Patients were should not have the intervention "Hernia belt compression" .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Within 3 months after surgery.
Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone.
Within 3 months after surgery.
Health-related quality of life
Time Frame: 1 day,7 days,1 month and 3 months after surgery.
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.
1 day,7 days,1 month and 3 months after surgery.
Hernia recurrence
Time Frame: 1 month,3 months,6 months and 12 months after surgery.
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.
1 month,3 months,6 months and 12 months after surgery.
Pain score
Time Frame: 1 day,7 days,1 month and 3 months after surgery.
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.
1 day,7 days,1 month and 3 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanchong Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guang'an People's Hospital
Pengan County People's Hospital
People's Hospital of Yilong County
Nanbu Hospital of County Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230910

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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