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

Completed

• Conditions: Hernia, Inguinal, Direct; Hernia; Inguinal Hernia; Incisional Hernia; Hernia, Inguinal, Indirect
• Interventions: Procedure: Hernia repair

• Registration Number: NCT02715622
• Lead Sponsor: Intuitive Surgical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-22
• Study Start: 2016-04
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 944

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Hernia Repair	Hernia repair	A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure
Robotic Hernia Repair	Hernia repair	A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure
Laparoscopic Hernia Repair	Hernia repair	A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incisional or Inguinal Hernia Recurrence through 3 years	30 days post-procedure through 3 years	Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.
Patient reported outcomes on post-procedure pain through 3 years	2-4 weeks post-procedure through 3 years post-procedure	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
Patient reported outcomes on Quality of Life through 1 year	Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life	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.

Trial Locations

Locations (17)

Progressive Surgical Associates; 🇺🇸 New Lenox, Illinois, United States

Southern Illinois Healthcare; 🇺🇸 Carbondale, Illinois, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

Our Lady of the Lake Regional Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Louisville Surgical Associates; 🇺🇸 Louisville, Kentucky, United States

New Hanover Regional Medical Center; 🇺🇸 Wilmington, North Carolina, United States

Hillcrest Medical Center; 🇺🇸 Tulsa, Oklahoma, United States

The Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Spectrum Health System; 🇺🇸 Grand Rapids, Michigan, United States

The Dallas VA Research Corporation; 🇺🇸 Dallas, Texas, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Beverly Hills Hernia Center; 🇺🇸 Beverly Hills, California, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, California, United States

Kaiser Foundation Research Institute; 🇺🇸 Oakland, California, United States

Baptist Health South Florida; 🇺🇸 South Miami, Florida, United States

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

Florida Hospital - Celebration Health; 🇺🇸 Celebration, Florida, United States