Vanderbilt Clinical Trials

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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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 Design

Phase
Study Type: Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
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

More Details

Status: Completed
Sponsor: Intuitive Surgical

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.