Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT00905320
Eligibility Criteria:
Inclusion Criteria:
Demographics:
* Age ≥ 18 years old
* If female, negative pregnancy test
Pre-Operative Findings:
* Presence of an abdominal hernia associated with previous surgical incision
* Midline ventral\\incisional hernia demonstrated either on physical examination by investigators or radiologic imaging tests.
* CT scan, MRI, Ultrasound
* No evidence of incarceration, strangulation
* Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)
* Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter
Exclusion Criteria:
Pre-Operative History:
* Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.
* History of the following:
* Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
* Chronic use (defined as greater than 3 months) of narcotic analgesic for pain other than from the hernia that is intended to be repaired
* Allergy to products used in hernia repair including surgical mesh
* Any abdominal ventral incisional hernia previously repaired with permanent synthetic mesh placed inside the peritoneal cavity
* Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of the abdominal musculature and fascia)
* Presence of simultaneous intra-abdominal infection
* Simultaneous presence of a bowel obstruction
* History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
Intra-operative Findings:
* Simultaneous performance of another surgical procedure during hernia repair other than acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)
* Intra-operative identification of full thickness injury to intestine (i.e. enterotomy), liver, bladder, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00905320
Study Brief:
Protocol Section:
NCT00905320