Hernia Belt in Laparoscopic Inguinal Hernia Repair

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061068
• Other study ID #: 20230910
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Nanchong Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Pain, Postoperative
• Quality of Life
• Recurrence
• Seroma

Intervention

Procedure:
• Hernia belt compression
Use the hernia belt to compress the inguinal region

Locations

Country	Name	City	State
China	Yunhong Tian	Nanchong	Sichuan

Sponsors (5)

Lead Sponsor	Collaborator
Nanchong Central Hospital	Guang'an People's Hospital, Nanbu Hospital of County Chinese Medicine, Pengan County People's Hospital, People's Hospital of Yilong County

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence	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.
Primary	Postoperative complications	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.
Primary	Pain score	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.
Primary	Health-related quality of life	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.