Clinical trial NCT02715622: A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Incisional Hernia
Hernia, Inguinal, Indirect
Hernia, Inguinal, Direct
Inguinal Hernia
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
Collaborators: name: Accelovance
First posted: 2016-03-22
Enrollment: 944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of complications observed intraoperatively through 30 days
timeFrame: 30 days
measure: Number of patient reported complications post 30-days through 3 years post procedure
timeFrame: 30 days post-procedure to 3 years post-procedure
Secondary outcomes:
measure: Patient reported outcomes on Quality of Life through 1 year
timeFrame: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life
measure: Incisional or Inguinal Hernia Recurrence through 3 years
timeFrame: 30 days post-procedure through 3 years
measure: Patient reported outcomes on post-procedure pain through 3 years
timeFrame: 2-4 weeks post-procedure through 3 years post-procedure
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Hernia Center
state: California
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Foundation Research Institute
state: California
city: Celebration
country: United States
facility: Florida Hospital - Celebration Health
state: Florida
city: South Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Carbondale
country: United States
facility: Southern Illinois Healthcare
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New Lenox
country: United States
facility: Progressive Surgical Associates
state: Illinois
city: Louisville
country: United States
facility: Louisville Surgical Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Dallas
country: United States
facility: The Dallas VA Research Corporation
state: Texas
Study officials:
affiliation: Surgeon Group of Baton Rouge
name: Karl LeBlanc, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.