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Hernia Belt in Laparoscopic Inguinal Hernia Repair

Primary Purpose

Hernia, Inguinal, Recurrence, Seroma Following Procedure

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hernia belt compression
Sponsored by
Nanchong Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Laparoscopic inguinal hernia repair, Hernia belt, Hernia recurrence, Seroma Following Procedure, Pain, Postoperative, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

  • Yunhong TianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hernia belt compressing group

No hernia belt compressing group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
Postoperative complications
Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2023
Last Updated
September 29, 2023
Sponsor
Nanchong Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06061068
Brief Title
Hernia Belt in Laparoscopic Inguinal Hernia Repair
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanchong Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Recurrence, Seroma Following Procedure, Pain, Postoperative, Quality of Life
Keywords
Laparoscopic inguinal hernia repair, Hernia belt, Hernia recurrence, Seroma Following Procedure, Pain, Postoperative, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hernia belt compressing group
Arm Type
Experimental
Arm 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.
Arm Title
No hernia belt compressing group
Arm Type
Active Comparator
Arm Description
Patients were should not have the intervention "Hernia belt compression" .
Intervention Type
Procedure
Intervention Name(s)
Hernia belt compression
Intervention Description
Use the hernia belt to compress the inguinal region
Primary Outcome Measure Information:
Title
Hernia recurrence
Description
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.
Time Frame
1 month,3 months,6 months and 12 months after surgery.
Title
Postoperative complications
Description
Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone.
Time Frame
Within 3 months after surgery.
Title
Pain score
Description
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.
Time Frame
1 day,7 days,1 month and 3 months after surgery.
Title
Health-related quality of life
Description
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.
Time Frame
1 day,7 days,1 month and 3 months after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Yunhong Tian
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhong Tian, PHD
Phone
13508087719
Email
drtianyunhong@126.com

12. IPD Sharing Statement

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Hernia Belt in Laparoscopic Inguinal Hernia Repair

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