Hernia Belt in Laparoscopic Inguinal Hernia Repair

Not Applicable

Completed

• Conditions: Seroma Following Procedure; Quality of Life; Pain, Postoperative; Hernia, Inguinal; Recurrence
• Interventions: Procedure: Hernia belt compression

• Registration Number: NCT06061068
• Lead Sponsor: Nanchong Central Hospital

Brief 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.

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 Timeline

• Study Start: 2023-07-17
• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Primary Completion: 2025-05-17
• Study Completion: 2025-05-17
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 678

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hernia belt compressing group	Hernia belt compression	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.

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	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.
Pain score	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.
Hernia recurrence	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.
Postoperative complications	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.

Trial Locations

Locations (1)

Yunhong Tian; 🇨🇳 Nanchong, Sichuan, China