Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair

NCT02379858 | Terminated Results DMC

• 1 other identifier: PRO24196
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia

Keywords

GI Tract Recovery; Hospital Discharge

Outcome Measures

Primary Outcomes (1)

• Length of Time (Hrs/Days) to Gastrointestinal Tract Recovery

  Time to gastrointestinal recovery will be measured by the following: Time to first flatus and time to first bowel movement measured twice daily. Toleration of a diet and toleration of oral pain medication defined as ingestion of diet or medications that occurs without vomiting or significant nausea for four hours following ingestion. GI-2 recovery defined as both toleration of solid food and occurrence of first bowel movement. GI-3 recovery is defined as toleration of solid food and either occurrence of first flatus or occurrence of first bowel movement. Patients requiring nasogastric tube insertion, requiring reduction or restriction of diet, having episodes of emesis, and/or needing initiation of Total Parenteral Nutrition (TPN) will be recorded. VAS (visual analog pain scale), nausea, and bloating will be recorded by nursing staff at least twice daily. The number of doses of anti-nausea medication administered during the hospitalization will also be recorded.

  Participants will be followed for the duration of hospital stay, an expected average of 1 week.

Secondary Outcomes (2)

• Length of Hospital Stay

  Participants will be followed for the duration of hospital stay, an expected average of 1 week

• 30-day Treatment Related Morbidity and Re-admission Rates

  Participants will be followed for the duration of hospital stay to 30 days after surgery, an expected average of 6 weeks

Study Arms (2)

Alvimopan (Entereg)

EXPERIMENTAL

Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Drug: Alvimopan

Suger Pill (Control)

PLACEBO COMPARATOR

Placebo, 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Drug: Placebo

Interventions

Alvimopan DRUG

Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Also known as: Entereg

Alvimopan (Entereg)

Placebo DRUG

Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.

Also known as: Sugar Pill

Suger Pill (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (11)

• Berger D, Bientzle M, Muller A. Postoperative complications after laparoscopic incisional hernia repair. Incidence and treatment. Surg Endosc. 2002 Dec;16(12):1720-3. doi: 10.1007/s00464-002-9036-y. Epub 2002 Sep 6.

  PMID: 12209325 BACKGROUND

• Buchler MW, Seiler CM, Monson JR, Flamant Y, Thompson-Fawcett MW, Byrne MM, Mortensen ER, Altman JF, Williamson R. Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study. Aliment Pharmacol Ther. 2008 Aug 1;28(3):312-25. doi: 10.1111/j.1365-2036.2008.03696.x.

  PMID: 19086236 BACKGROUND

• Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.

  PMID: 17435541 BACKGROUND

• Lowe JB 3rd, Lowe JB, Baty JD, Garza JR. Risks associated with "components separation" for closure of complex abdominal wall defects. Plast Reconstr Surg. 2003 Mar;111(3):1276-83; quiz 1284-5; discussion 1286-8. doi: 10.1097/01.PRS.0000047021.36879.FD.

  PMID: 12621202 BACKGROUND

• Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.

  PMID: 19015469 BACKGROUND

• McGreevy JM, Goodney PP, Birkmeyer CM, Finlayson SR, Laycock WS, Birkmeyer JD. A prospective study comparing the complication rates between laparoscopic and open ventral hernia repairs. Surg Endosc. 2003 Nov;17(11):1778-80. doi: 10.1007/s00464-002-8851-5. Epub 2003 Sep 10.

  PMID: 12958679 BACKGROUND

• Vargo D. Component separation in the management of the difficult abdominal wall. Am J Surg. 2004 Dec;188(6):633-7. doi: 10.1016/j.amjsurg.2004.08.051.

  PMID: 15619476 BACKGROUND

• Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA; Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004 Oct;240(4):728-34; discussion 734-5. doi: 10.1097/01.sla.0000141158.27977.66.

  PMID: 15383800 BACKGROUND

• Wolff BG, Weese JL, Ludwig KA, Delaney CP, Stamos MJ, Michelassi F, Du W, Techner L. Postoperative ileus-related morbidity profile in patients treated with alvimopan after bowel resection. J Am Coll Surg. 2007 Apr;204(4):609-16. doi: 10.1016/j.jamcollsurg.2007.01.041.

  PMID: 17382220 BACKGROUND

• Itawi EA, Savoie LM, Hanna AJ, Apostolides GY. Alvimopan addition to a standard perioperative recovery pathway. JSLS. 2011 Oct-Dec;15(4):492-8. doi: 10.4293/108680811X13176785204076.

  PMID: 22643504 BACKGROUND

• Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.

  PMID: 21904861 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Interventions

alvimopan; Sugars

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Matthew Goldblatt, MD
• Organization: Medical College of Wisconsin

mgoldbla@mcw.edu

414-955-5751

Study Officials

• Matthew I Goldblatt, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Condon Hernia Institute, Associate Professor of Surgery

Study Record Dates

• First Submitted: February 21, 2015
• First Posted: March 5, 2015
• Study Start: July 1, 2015
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: November 14, 2019
• Results First Posted: October 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)