A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia… (NCT02715622) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
United States944 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Emergent Cases for both Incisional and Inguinal Hernia
. Incisional Hernia related to ostomy formation
. Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of complications observed intraoperatively through 30 days
Timeframe: 30 days
2
Number of patient reported complications post 30-days through 3 years post procedure
Timeframe: 30 days post-procedure to 3 years post-procedure