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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT02379858
Eligibility Criteria:
Inclusion Criteria:
1. Subjects will be informed about the study, have read, understood, and signed the Informed Consent Form
2. Subjects of either gender that are ≥18 years of age
3. Subjects who can ambulate preoperatively
4. Subjects will have a Body-Mass Index (BMI) of ≤ 40mg/m2
5. Subjects with an American Society of Anesthesiologists (ASA) classification of 1, 2 or 3
6. Subjects not receiving an epidural to control perioperative pain
7. Subjects will be undergoing elective single-staged open ventral (incisional or midline) hernia repair
8. Subjects in which intra-operatively their surgical field/wound is characterized as Type 1 (Appendix II)
9. Subjects with a hernia defect ≥9 cm2 large
Exclusion Criteria:
1. Subjects who are not able to comprehend or comply with study requirements
2. Subjects who are pregnant
3. Subjects with BMI \> 40
4. Subjects with autoimmune disorder requiring \>10mg of a corticosteroid per day
5. Subjects with pre-existing systemic infections
6. Subjects with a wound-healing disorder
7. Subjects who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking Alvimopan
8. Subjects who are immunocompromised such as HIV or transplant, or receiving chemo or radiation therapy
9. Subjects with a hernia defect \< 9cm2 large when measured intra-operatively
10. Subjects in which intra-operatively their surgical wound field/wound is characterized as Type 2, 3, or 4 (Appendix II)
11. Subjects in which the ventral incisional hernia repair requires more than one operation to reduce the hernia or to complete the hernia repair
12. Subjects with a hernia repair requiring an emergent procedure
13. Subjects in which untreated cancer was found intra-operatively
14. Subjects with cirrhosis or are currently being treated with dialysis
15. Subjects with severe hepatic impairment (Childs-Pugh class C)
16. Subjects with end-stage renal disease
17. Subjects scheduled for a concomitant procedure that involves the GI tract
18. Subjects with unplanned procedures that involve the GI tract
19. Subjects requiring post-operative NGT
20. Subjects participating in another prospective interventional study that involves the use of a device, drug, or surgery that would compromise the current study
21. Subjects with an epidural to control perioperative pain
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02379858
Study Brief:
Protocol Section:
NCT02379858