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Completed

NCT Number: NCT06061068

Hernia Belt in 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.

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Key information

Conditions

Hernia, Inguinal Disease Attributes Hernia Hernia, Abdominal Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life Recurrence Seroma Following Procedure Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunhong Tian

Nanchong, Sichuan, 637000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Hernia belt compression

Procedure

Use the hernia belt to compress the inguinal region

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Collaborators

  • Guang'an People's Hospital
  • Nanbu Hospital of County Chinese Medicine
  • Pengan County People's Hospital
  • People's Hospital of Yilong County

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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