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A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients

NCT02715622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 944

Last updated 2023-03-01

No results posted yet for this study

Summary

The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.

The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.

Conditions

  • Hernia
  • Incisional Hernia
  • Hernia, Inguinal, Indirect
  • Hernia, Inguinal, Direct
  • Inguinal Hernia

Interventions

PROCEDURE

Hernia repair

Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

Sponsors & Collaborators

  • Accelovance

    collaborator INDUSTRY

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • Karl LeBlanc, MD · Surgeon Group of Baton Rouge

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715622 on ClinicalTrials.gov