A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
Completed
Conditions studied: Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct, Inguinal Hernia
In brief
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.
Key facts
- Study ID
- NCT02715622
- Run by
- Intuitive Surgical
- People needed
- 944
- Starts
- 2016-04-01
- Expected to finish
- 2022-10-01
- Last updated by the study team
- 2023-03-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years and older
- All patients undergoing either an open, laparoscopic or robotic-assisted
- Incisional or Inguinal Hernia repair procedure
- Non-Emergent Incisional or Inguinal Hernia Repair cases
You may not qualify if…
- Emergent Cases for both Incisional and Inguinal Hernia
- Incisional Hernia related to ostomy formation
- Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
Where it is running
- 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
- Florida Hospital - Celebration Health — Celebration, Florida, United States
- Baptist Health South Florida — South Miami, Florida, United States
- Southern Illinois Healthcare — Carbondale, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Progressive Surgical Associates — New Lenox, Illinois, United States
- Louisville Surgical Associates — Louisville, Kentucky, United States
- Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Spectrum Health System — Grand Rapids, Michigan, United States
- The Mount Sinai Medical Center — New York, New York, United States
- New Hanover Regional Medical Center — Wilmington, North Carolina, United States
- Hillcrest Medical Center — Tulsa, Oklahoma, United States
- University of Tennessee — Memphis, Tennessee, United States
- The Dallas VA Research Corporation — Dallas, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.