NCT06061068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

September 24, 2023

Last Update Submit

May 16, 2025

Conditions

Hernia, InguinalRecurrenceSeroma Following ProcedurePain, PostoperativeQuality of Life

Keywords

Laparoscopic inguinal hernia repairHernia beltHernia recurrenceSeroma Following ProcedurePain, PostoperativeQuality of Life

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (2)

Hernia belt compressing group

EXPERIMENTAL

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

No hernia belt compressing group

NO INTERVENTION

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

Interventions

Hernia belt compressionPROCEDURE

Use the hernia belt to compress the inguinal region

Hernia belt compressing group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunhong Tian

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Hernia, InguinalRecurrencePain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastrointestinal, Colorectal and Hernia Surgery

Study Record Dates

First Submitted

September 24, 2023

First Posted

September 29, 2023

Study Start

July 17, 2023

Primary Completion

May 17, 2025

Study Completion

May 17, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Locations

CN(1)