Hernia Belt in Laparoscopic Inguinal Hernia Repair

March 19, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

320

Phase

  • 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
        • Recruiting
        • Yunhong Tian
        • Contact:

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

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
Intervention / Treatment
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

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

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

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)

July 17, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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