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

A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Hernia; Incisional Hernia; Hernia, Inguinal, Indirect; Hernia, Inguinal, Direct
• Intervention / Treatment: Procedure: Hernia repair

• Study Type: Observational
• Enrollment (Actual): 944

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Beverly Hills Hernia Center
    • Nashville, California, United States, 37232
      • Vanderbilt University Medical Center
    • Oakland, California, United States, 94612
      • Kaiser Foundation Research Institute
  • Florida
    • Celebration, Florida, United States, 34747
      • Florida Hospital - Celebration Health
    • South Miami, Florida, United States, 33143
      • Baptist Health South Florida
  • Illinois
    • Carbondale, Illinois, United States, 62901
      • Southern Illinois Healthcare
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • New Lenox, Illinois, United States, 60451
      • Progressive Surgical Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Louisville Surgical Associates
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Regional Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health System
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • New Hanover Regional Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • University of Tennessee
  • Texas
    • Dallas, Texas, United States, 75216
      • The Dallas VA Research Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

At least 900 patients will be enrolled in this post-market study that is planned to be conducted for mainly 2 types of hernia repairs, Incisional hernia repair and inguinal hernia repair ( robotic-assisted, lap and open). Up to 2000 patients may be enrolled.

Approximately 450 patients who will undergo inguinal hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) and approximately 450 patients who will undergo incisional hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) will be enrolled in this study at up to thirty (30) study centers

Description

Inclusion Criteria:

1. Age 18 years and older
2. All patients undergoing either an open, laparoscopic or robotic-assisted
3. Incisional or Inguinal Hernia repair procedure
4. Non-Emergent Incisional or Inguinal Hernia Repair cases

Exclusion Criteria:

1. Emergent Cases for both Incisional and Inguinal Hernia
2. Incisional Hernia related to ostomy formation
3. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open Hernia Repair; A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure	Procedure: Hernia repair; Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Laparoscopic Hernia Repair; A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure	Procedure: Hernia repair; Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
Robotic Hernia Repair; A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure	Procedure: Hernia repair; Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complications observed intraoperatively through 30 days	Number of intraoperative and short-term complications related to hernia repair.	30 days
Number of patient reported complications post 30-days through 3 years post procedure	Number of long-term complications related to hernia repair directly reported by patients	30 days post-procedure to 3 years post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcomes on Quality of Life through 1 year	Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year.	Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life
Incisional or Inguinal Hernia Recurrence through 3 years	Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.	30 days post-procedure through 3 years
Patient reported outcomes on post-procedure pain through 3 years	Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take	2-4 weeks post-procedure through 3 years post-procedure

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Collaborators: Accelovance
• Investigators: Study Chair: Karl LeBlanc, MD, Surgeon Group of Baton Rouge

Publications and helpful links

General Publications

• LeBlanc KA, Gonzalez A, Dickens E, Olsofka J, Ortiz-Ortiz C, Verdeja JC, Pierce R; Prospective Hernia Study Group. Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study. Hernia. 2021 Aug;25(4):1071-1082. doi: 10.1007/s10029-021-02381-0. Epub 2021 May 24.
• LeBlanc KA. Design of a comparative outcome analysis of open, laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model. Contemp Clin Trials. 2019 Nov;86:105853. doi: 10.1016/j.cct.2019.105853. Epub 2019 Oct 25.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Incisional Hernia
• Other Study ID Numbers: ISI-PHS-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED