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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715622
• Other study ID #: ISI-PHS-2016
• Status: Completed
• Start date: April 2016
• Est. completion date: October 2022

Study information

• Verified date: February 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 944
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	Beverly Hills Hernia Center	Beverly Hills	California
United States	Southern Illinois Healthcare	Carbondale	Illinois
United States	Florida Hospital - Celebration Health	Celebration	Florida
United States	Rush University Medical Center	Chicago	Illinois
United States	The Dallas VA Research Corporation	Dallas	Texas
United States	Spectrum Health System	Grand Rapids	Michigan
United States	Louisville Surgical Associates	Louisville	Kentucky
United States	University of Tennessee	Memphis	Tennessee
United States	Vanderbilt University Medical Center	Nashville	California
United States	Progressive Surgical Associates	New Lenox	Illinois
United States	The Mount Sinai Medical Center	New York	New York
United States	Kaiser Foundation Research Institute	Oakland	California
United States	Baptist Health South Florida	South Miami	Florida
United States	Hillcrest Medical Center	Tulsa	Oklahoma
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Intuitive Surgical	Accelovance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications observed intraoperatively through 30 days	Number of intraoperative and short-term complications related to hernia repair.	30 days
Primary	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	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
Secondary	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
Secondary	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