Ventral HerniaNCT02379858
Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair
A study testing Alvimopan in people with Ventral Hernia, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Alvimopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair: A Multi-Center, Randomized, Double-Blind, Trial of Alvimopan and Placebo
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.
Read the detailed description
Background: One of the most common occurrences following ventral incisional hernia repair is post-operative ileus. Post-operative ileus is a source of patient discomfort and morbidity that ultimately delays discharge from the hospital and is frequently a source of patient readmission. Prolonged length of hospital stay due to post-operative ileus increases direct health care costs, as well as the indirect costs of a delay in returning to the workforce. The cause of prolonged ileus is multifactorial, but some of the main culprits include intra-operative bowel manipulation, the release of endogenous opioids, the administration of exogenous opioid analgesics during surgery and for post-operative pain control, inflammation, and fluid shifts. A study by Lowe et al showed that following ventral hernia repair, 27% of their study patients had a prolonged ileus, defined as lasting more than 7 days postoperatively. Likewise, the mean hospital stay for these patients was 12.5 days, due most frequently, to a delayed return of bowel function.
Ventral incisional hernia repair is a common operation and post-operative ileus remains a frequent and costly post-operative occurrence for which we do not currently have an effective therapy. Alvimopan has proven to successfully decrease the duration of post-operative ileus and is FDA approved for such use in patients who have undergone bowel resection. Ultimately, decreasing the interlude between operation and return of bowel function results in shorter hospital stays, lower hospital costs, and faster rehabilitation. We propose to study the effectiveness of Alvimopan in decreasing postoperative ileus time in patients undergoing ventral hernia repair, a cohort that we feel may benefit from the use of Alvimopan but that to date has not been studied.
Recruitment and Sample Size: A total of 140 patients are expected to undergo research related treatments. The study will contain one open surgery arm. The open surgery arm will be a single-site prospective, randomized, double-blinded, placebo-controlled clinical trial with 1:1 randomization between the study drug and placebo with 70 patients in each group for a total of 140 patients in the study. An interim evaluation of efficacy will be conducted separately in the open surgery arm when half the patients have been recruited.
This study is expected to enroll up to 140 subjects from one academic medical center (Froedtert Hospital and the Medical College of Wisconsin) a site that performs state of the art hernia repairs and is a high volume hernia practices.
Treatment: Consented patients in the Treatment Group will receive 12 milligrams (mg) of Alvimopan per-oral (PO) 30 to 90 minutes prior to ventral hernia repair in the pre-operative area and continue 12 mg PO twice daily until hospital discharge or post-operative day (POD) 7 for a maximum of 15 in-hospital doses (Appendix II). The first post-operative dose will begin after Nasogastric Tube (NGT) removal.
Patients in the Control Group will receive 12 milligrams (mg) of Placebo orally (PO) 30 to 90 minutes prior to Ventral Hernia Repair (VHR) in the pre-operative area and continue 12 mg PO twice a day until hospital discharge or post-operative (POD) 7 for a maximum of 15 in-hospital doses. The first post-operative dose will begin after NGT removal.
Warnings and precautions as provided in the prescribing information packet and US PI include:
- A higher number of myocardial infarctions was reported in patients treated with alvimopan 0.5 mg twice daily compared with placebo 12 in a 12-month study in patients treated with opioids for chronic pain, although a causal relationship has not been established
- Patients recently exposed to opioids are expected to be more sensitive to the effects of ENTEREG and therefore may experience abdominal pain, nausea and vomiting, and diarrhea.
- Not recommended in patients with severe hepatic impairment.
- Not recommended in patients with end stage renal disease.
- Most common adverse reaction (incidence >=1.5%) occurring with a higher frequency than placebo among ENTEREG-treated patients undergoing surgeries that included a bowel resection was dyspepsia [2013 PI].
- Not recommended in patients with complete GI obstruction or in patients who have surgery for correction of complete bowel obstruction.
- Not recommended in pancreatic or gastric anastomosis.
- Conditions
- Ventral Hernia
- Being tested
- Alvimopan, Placebo
- Keywords
- GI Tract Recovery, Hospital Discharge
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
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.
PlaceboDrug
Also called Sugar Pill
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Secondary outcomes (2)
Length of Hospital Stay
Length of stay will be measured in hours from the time that surgery is completed until the hospital discharge order is written (hrs/days).
Measured: 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
Treatment (study drug) and surgery (complications as a direct result of surgery) related morbidity and re-admission rates will be assessed from the time surgery is completed to 30-days post-operatively. Treatment related morbidity and re-admission rates include: post-operative ileus (POI), indigestion and any event determined by the attending physician to be directly related to treatment (study drug). Surgical complications include: hernia recurrence, infections, and any event determined by the attending physician to be directly related to surgery.
Measured: Participants will be followed for the duration of hospital stay to 30 days after surgery, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJul 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Why it stopped: Manufacturer of Alvimopam closed the study due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Matthew I. Goldblatt, Medical College of Wisconsin
- Investigators
- Matthew I Goldblatt, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379858
- Sponsor's protocol ID
- PRO24196
- Status last verified
- Nov 2019
- First submitted
- 21 Feb 2015
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12209325Buchler 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.
PubMed 19086236Delaney 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.
PubMed 17435541Lowe 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.
PubMed 12621202Ludwig 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.
PubMed 19015469McGreevy 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.
PubMed 12958679Vargo 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.
PubMed 15619476Wolff 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.
PubMed 15383800Wolff 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.
PubMed 17382220Itawi 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.
PubMed 22643504Poulose 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.
PubMed 21904861
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair: A Multi-Center, Randomized, Double-Blind, Trial of Alvimopan and Placebo
- ClinicalTrials.gov ID
- NCT02379858
- Acronym / sponsor ID
- PRO24196
- Conditions
- Ventral Hernia
- Keywords
- GI Tract Recovery, Hospital Discharge
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturer of Alvimopam closed the study due to low enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Posted 29 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: One of the most common occurrences following ventral incisional hernia repair is post-operative ileus. Post-operative ileus is a source of patient discomfort and morbidity that ultimately delays discharge from the hospital and is frequently a source of patient readmission. Prolonged length of hospital stay due to post-operative ileus increases direct health care costs, as well as the indirect costs of a delay in returning to the workforce. The cause of prolonged ileus is multifactorial, but some of the main culprits include intra-operative bowel manipulation, the release of endogenous opioids, the administration of exogenous opioid analgesics during surgery and for post-operative pain control, inflammation, and fluid shifts. A study by Lowe et al showed that following ventral hernia repair, 27% of their study patients had a prolonged ileus, defined as lasting more than 7 days postoperatively. Likewise, the mean hospital stay for these patients was 12.5 days, due most frequently, to a delayed return of bowel function.
Ventral incisional hernia repair is a common operation and post-operative ileus remains a frequent and costly post-operative occurrence for which we do not currently have an effective therapy. Alvimopan has proven to successfully decrease the duration of post-operative ileus and is FDA approved for such use in patients who have undergone bowel resection. Ultimately, decreasing the interlude between operation and return of bowel function results in shorter hospital stays, lower hospital costs, and faster rehabilitation. We propose to study the effectiveness of Alvimopan in decreasing postoperative ileus time in patients undergoing ventral hernia repair, a cohort that we feel may benefit from the use of Alvimopan but that to date has not been studied.
Recruitment and Sample Size: A total of 140 patients are expected to undergo research related treatments. The study will contain one open surgery arm. The open surgery arm will be a single-site prospective, randomized, double-blinded, placebo-controlled clinical trial with 1:1 randomization between the study drug and placebo with 70 patients in each group for a total of 140 patients in the study. An interim evaluation of efficacy will be conducted separately in the open surgery arm when half the patients have been recruited.
This study is expected to enroll up to 140 subjects from one academic medical center (Froedtert Hospital and the Medical College of Wisconsin) a site that performs state of the art hernia repairs and is a high volume hernia practices.
Treatment: Consented patients in the Treatment Group will receive 12 milligrams (mg) of Alvimopan per-oral (PO) 30 to 90 minutes prior to ventral hernia repair in the pre-operative area and continue 12 mg PO twice daily until hospital discharge or post-operative day (POD) 7 for a maximum of 15 in-hospital doses (Appendix II). The first post-operative dose will begin after Nasogastric Tube (NGT) removal.
Patients in the Control Group will receive 12 milligrams (mg) of Placebo orally (PO) 30 to 90 minutes prior to Ventral Hernia Repair (VHR) in the pre-operative area and continue 12 mg PO twice a day until hospital discharge or post-operative (POD) 7 for a maximum of 15 in-hospital doses. The first post-operative dose will begin after NGT removal.
Warnings and precautions as provided in the prescribing information packet and US PI include:
- A higher number of myocardial infarctions was reported in patients treated with alvimopan 0.5 mg twice daily compared with placebo 12 in a 12-month study in patients treated with opioids for chronic pain, although a causal relationship has not been established
- Patients recently exposed to opioids are expected to be more sensitive to the effects of ENTEREG and therefore may experience abdominal pain, nausea and vomiting, and diarrhea.
- Not recommended in patients with severe hepatic impairment.
- Not recommended in patients with end stage renal disease.
- Most common adverse reaction (incidence >=1.5%) occurring with a higher frequency than placebo among ENTEREG-treated patients undergoing surgeries that included a bowel resection was dyspepsia [2013 PI].
- Not recommended in patients with complete GI obstruction or in patients who have surgery for correction of complete bowel obstruction.
- Not recommended in pancreatic or gastric anastomosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alvimopan (Entereg) | Experimental | Drug: AlvimopanAlvimopan, 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. |
| Suger Pill (Control) | Placebo comparator | Drug: PlaceboPlacebo, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlvimopanAlso: EnteregAlvimopan, 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 (Entereg) |
| PlaceboAlso: Sugar PillPlacebo (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. | Drug | Suger Pill (Control) |
Primary outcome
Length of Time (Hrs/Days) to Gastrointestinal Tract Recovery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week.
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.
2 secondary outcomes
Length of Hospital Stay
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay to 30 days after surgery, an expected average of 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12209325Berger 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.
- Background: PubMed 19086236Buchler 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.
- Background: PubMed 17435541Delaney 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.
- Background: PubMed 12621202Lowe 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.
- Background: PubMed 19015469Ludwig 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.
- Background: PubMed 12958679McGreevy 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.
- Background: PubMed 15619476Vargo 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.
- Background: PubMed 15383800Wolff 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.
- Background: PubMed 17382220Wolff 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.
- Background: PubMed 22643504Itawi 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.
- Background: PubMed 21904861Poulose 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew I Goldblatt, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alvimopan in people with Ventral Hernia, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Time (Hrs/Days) to Gastrointestinal Tract Recovery (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379858, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.