Hernia Belt in Laparoscopic Inguinal Hernia Repair

Nanchong Central Hospital

Status: Enrolling

Conditions: Quality of Life; Hernia, Inguinal; Pain, Postoperative; Seroma Following Procedure; Recurrence

Treatments: Procedure: Hernia belt compression

Study type: Interventional

Funder types: Other

Identifiers

NCT06061068

20230910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Hernia belt compressing group

Experimental group

Description:

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.

Treatment:

Procedure: Hernia belt compression

No hernia belt compressing group

No Intervention group

Description:

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