Hernia Belt in Laparoscopic Inguinal Hernia Repair

Study Overview
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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.

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.

Official Title
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The Effect of Hernia Belt on Postoperative Complications and Quality of Life for Patients Who Underwent Laparoscopic Inguinal Hernia Repair:a Randomized Clinical Trial

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

Intervention / Treatment
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* Procedure: Hernia belt compression


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Incarcerated hernia, recurrent hernia and other types of hernia. Patients presenting for obvious contraindications to surgery. Need for an open inguinal hernia repair. Difficult to follow-up or communication. Patients who are unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hernia belt compressing group<br>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<br>* Use the hernia belt to compress the inguinal region<br>|
| No Intervention: No hernia belt compressing group<br>Patients were should not have the intervention Hernia belt compression . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic inguinal hernia repair, Hernia belt, Hernia recurrence, Seroma Following Procedure, Pain, Postoperative, Quality of Life