Hernia Belt in Laparoscopic Inguinal Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2025-05-17

Brief Summary

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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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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Hernia belt compression

Intervention Type PROCEDURE

Use the hernia belt to compress the inguinal region

No hernia belt compressing group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hernia belt compression

Use the hernia belt to compress the inguinal region

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No