Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

Stopped early · Not applicable · Has a placebo group

Conditions studied: Ventral Hernia

In brief

The purpose of this study is to determine whether Alvimopan (Entereg) in ventral hernia surgery patients is associated with accelerated gastrointestinal recovery and reduced length of hospital stay compared to placebo controls.

Key facts

Study ID

NCT02379858

Run by

Medical College of Wisconsin

People needed

10

Starts

2015-07-01

Expected to finish

2018-05-31

Last updated by the study team

2019-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be informed about the study, have read, understood, and signed the Informed Consent Form
• Subjects of either gender that are ≥18 years of age
• Subjects who can ambulate preoperatively
• Subjects will have a Body-Mass Index (BMI) of ≤ 40mg/m2
• Subjects with an American Society of Anesthesiologists (ASA) classification of 1, 2 or 3
• Subjects not receiving an epidural to control perioperative pain
• Subjects will be undergoing elective single-staged open ventral (incisional or midline) hernia repair
• Subjects in which intra-operatively their surgical field/wound is characterized as Type 1 (Appendix II)
• Subjects with a hernia defect ≥9 cm2 large

You may not qualify if…

• Subjects who are not able to comprehend or comply with study requirements
• Subjects who are pregnant
• Subjects with BMI > 40
• Subjects with autoimmune disorder requiring >10mg of a corticosteroid per day
• Subjects with pre-existing systemic infections
• Subjects with a wound-healing disorder
• Subjects who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking Alvimopan
• Subjects who are immunocompromised such as HIV or transplant, or receiving chemo or radiation therapy
• Subjects with a hernia defect < 9cm2 large when measured intra-operatively
• Subjects in which intra-operatively their surgical wound field/wound is characterized as Type 2, 3, or 4 (Appendix II)
• Subjects in which the ventral incisional hernia repair requires more than one operation to reduce the hernia or to complete the hernia repair
• Subjects with a hernia repair requiring an emergent procedure
• Subjects in which untreated cancer was found intra-operatively
• Subjects with cirrhosis or are currently being treated with dialysis
• Subjects with severe hepatic impairment (Childs-Pugh class C)
• Subjects with end-stage renal disease
• Subjects scheduled for a concomitant procedure that involves the GI tract
• Subjects with unplanned procedures that involve the GI tract
• Subjects requiring post-operative NGT
• Subjects participating in another prospective interventional study that involves the use of a device, drug, or surgery that would compromise the current study
• Subjects with an epidural to control perioperative pain

Where it is running

• Froedtert & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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