Hernia Belt in Laparoscopic Inguinal Hernia Repair

Sponsor

Nanchong Central Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06061068

Collaborator

(none)

178

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

32.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal Recurrence Seroma Following Procedure Pain, Postoperative Quality of Life	Procedure: Hernia belt compression	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

178 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jul 17, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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
Active Comparator: No hernia belt compressing group Patients were should not have the intervention "Hernia belt compression" .	Procedure: Hernia belt compression Use the hernia belt to compress the inguinal region

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

Active Comparator: No hernia belt compressing group

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

Procedure: Hernia belt compression

Use the hernia belt to compress the inguinal region

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.