Postoperative IleusPhase 4NCT02161367
Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery
A Phase 4 study testing Simethicone in people with Postoperative Ileus and Ileus, run by McMaster University at 2 sites in Canada.
Trial summary
Post-operative ileus is a common complication following abdominal surgery. It results in abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this results in prolonged hospital stay and occasionally readmission following abdominal surgery.The etiology of post-operative ileus is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Ileus
- What is being tested?
- Simethicone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2014to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis (both open and laparoscopic surgeries) at either the Juravinski Hospital and Cancer Center or St. Joseph's Hospital in Hamilton
Who cannot join
- Patients undergoing emergency surgery
- Documented allergy to simethicone
- Unable to provide informed consent (non-English speaking patients and those with cognitive impairment)
- Patients not having an abdominal operation (ie. perineal procedure)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
About this study
Official title: A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study
Post-operative ileus is a common complication following abdominal surgery. It results in abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this results in prolonged hospital stay and occasionally readmission following abdominal surgery.The etiology of post-operative ileus is multifactorial and studies evaluating potential treatment options are abundant, though few reliable interventions exist. This study proposal describes a double-blinded randomized controlled trial investigating the effect of simethicone on post-operative ileus in patients undergoing colorectal surgery.
Read the detailed description
Simethicone is an orally administered anti-foaming agent comprised of polydimethylsiloxane and hydrated silica gel. Its leads to the coalescence of gas bubbles in the intestinal tract, facilitating its emission. To date, there are no contemporary studies evaluating the efficacy of simethicone on POI in patients undergoing colorectal surgery.
The proposed study is a pilot double-blinded randomized controlled trial of simethicone versus placebo in patients undergoing colorectal surgery. Starting on postoperative day one, patients in the experimental arm of the study will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. Patients assigned to the control arm will receive a placebo agent orally with the same frequency and duration.
All consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis at either the Juravinski Hospital and Cancer Center or St. Joseph's Hospital in Hamilton, Ontario will be enrolled. This will include patients undergoing both open and laparoscopic surgery.
Patients will be prospectively evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day.
- Conditions
- Postoperative Ileus, Ileus
- Being tested
- Simethicone, Oral Suspending Vehicle
- Keywords
- colorectal surgery, postoperative ileus, simethicone, randomized controlled trial, double blind, pilot study, anti-foaming agent, abdominal pain, abdominal distention, nausea vomiting, flatus, bowel movement, placebo, postoperative complications, polydimethylsiloxane, hydrated silica gel, gas bubbles, intestinal tract
- Medical subject headings
- Ileus, Abdominal Pain, Flatulence, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
Also called OVOL®
Pharmacological category: antiflatulent
160mg Simethicone orally, 4 times a day for the first five postoperative days
Oral Suspending VehicleDrug
Also called ORA-Plus®
ORA-Plus is an aqueous-based vehicle.
Identical to the test drug formulation except for being pharmacologically inert. 160mg Ora-Plus orally, 4 times a day for the first five postoperative days
| Study group | Role | What they receive |
|---|---|---|
| Simethicone, OVOL | Experimental | Patients in the intervention arm will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. Patients will be evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day. Receives: Drug: Simethicone |
| Oral Suspending Vehicle, Ora-Plus | Placebo comparator | Patients in the control arm will receive, in a blinded fashion, 160mg of the placebo orally four times a day for the first five postoperative days. The placebo will be prepared by pharmacy to be identical to the test drug formulation except for being pharmacologically inert. Patients will be evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day. Receives: Drug: Oral Suspending Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first passage of flatus
passage of flatus (measured in hours) is considered an acceptable sign of the return of gut function and a criterion for discharge from hospital (bowel movement is not)
Measured: participants will be followed for the duration of their hospital stay, an expected average of 7 days
Secondary outcomes (6)
time to first bowel movement
Measured: participants will be followed for the duration of their hospital stay, an expected average of 7 days
length of hospital stay
Measured: participants will be followed for the duration of their hospital stay, an expected average of 7 days
postoperative pain
measured using the Visual Analogue Scale for pain
Measured: participants will be followed for the duration of their hospital stay, an expected average of 7 days
postoperative narcotic requirements
Measured: participants will be followed for the duration of their hospital stay, an expected average of 7 days
incidence of postoperative vomiting
Measured: participants will be followed for the duration of their hospital stay, an expected average of 7 days
incidence of postoperative complications
including but not limited to wound and anastomotic occurences, bleeding, infections, readmission to hospital, death, etc.
Measured: within the first 30 days (plus or minus 3 days) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Sponsor
- Investigators
- Shawn S Forbes, MD, MSc, Principal investigator, McMaster UniversityCagla Eskicioglu, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161367
- Sponsor's protocol ID
- Simethicone-CRSurgery-1415
- Status last verified
- Dec 2015
- First submitted
- 5 Jun 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
Publications
Doorly MG, Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Surg Clin North Am. 2012 Apr;92(2):259-72, viii. doi: 10.1016/j.suc.2012.01.010.
PubMed 22414412Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.
PubMed 19590205Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. doi: 10.1016/s0002-9610(01)00781-4.
PubMed 11755891Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S3-7. doi: 10.2146/ajhp070428.
PubMed 17909274Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.
PubMed 21730280Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16. doi: 10.1111/j.1743-3150.2004.00553.x.
PubMed 15357847Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.
PubMed 15357852Hocevar BJ, Robinson B, Gray M. Does chewing gum shorten the duration of postoperative ileus in patients undergoing abdominal surgery and creation of a stoma? J Wound Ostomy Continence Nurs. 2010 Mar-Apr;37(2):140-6. doi: 10.1097/WON.0b013e3181d0b92b.
PubMed 20228654Danhof IE, Stavola JJ. Accelerated transit of intestinal gas with simethicone. Obstet Gynecol. 1974 Jul;44(1):148-54. No abstract available.
PubMed 4600627Gibstein A, Cooper JJ, Wisot AL, Rosenthal AH. Prevention of postoperative abdominal distention and discomfort with simethicone. Obstet Gynecol. 1971 Sep;38(3):386-90. No abstract available.
PubMed 4937581Chan MK, Law WL. Use of chewing gum in reducing postoperative ileus after elective colorectal resection: a systematic review. Dis Colon Rectum. 2007 Dec;50(12):2149-57. doi: 10.1007/s10350-007-9039-9.
PubMed 17710495Forbes SS, Stephen WJ, Harper WL, Loeb M, Smith R, Christoffersen EP, McLean RF. Implementation of evidence-based practices for surgical site infection prophylaxis: results of a pre- and postintervention study. J Am Coll Surg. 2008 Sep;207(3):336-41. doi: 10.1016/j.jamcollsurg.2008.03.014. Epub 2008 May 19.
PubMed 18722937Eskicioglu C, Gagliardi A, Fenech DS, Victor CJ, McLeod RS. Can a tailored knowledge translation strategy improve short term outcomes? A pilot study to increase compliance with bowel preparation recommendations in general surgery. Surgery. 2011 Jul;150(1):68-74. doi: 10.1016/j.surg.2011.02.010. Epub 2011 May 18.
PubMed 21596413
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effect of Simethicone on Postoperative Ileus in Patients Undergoing Colorectal Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT02161367
- Acronym / sponsor ID
- Simethicone-CRSurgery-1415
- Conditions
- Postoperative Ileus, Ileus
- Keywords
- colorectal surgery, postoperative ileus, simethicone, randomized controlled trial, double blind, pilot study, anti-foaming agent, abdominal pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative ileus is a common complication following abdominal surgery. It results in abdominal distension, nausea and vomiting as well as abdominal pain. Furthermore, this results in prolonged hospital stay and occasionally readmission following abdominal surgery.The etiology of post-operative ileus is multifactorial and studies evaluating potential treatment options are abundant, though few reliable interventions exist. This study proposal describes a double-blinded randomized controlled trial investigating the effect of simethicone on post-operative ileus in patients undergoing colorectal surgery.
Detailed description
Simethicone is an orally administered anti-foaming agent comprised of polydimethylsiloxane and hydrated silica gel. Its leads to the coalescence of gas bubbles in the intestinal tract, facilitating its emission. To date, there are no contemporary studies evaluating the efficacy of simethicone on POI in patients undergoing colorectal surgery.
The proposed study is a pilot double-blinded randomized controlled trial of simethicone versus placebo in patients undergoing colorectal surgery. Starting on postoperative day one, patients in the experimental arm of the study will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. Patients assigned to the control arm will receive a placebo agent orally with the same frequency and duration.
All consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis at either the Juravinski Hospital and Cancer Center or St. Joseph's Hospital in Hamilton, Ontario will be enrolled. This will include patients undergoing both open and laparoscopic surgery.
Patients will be prospectively evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simethicone, OVOL | Experimental | Drug: SimethiconePatients in the intervention arm will receive, in a blinded fashion, 160mg of simethicone orally four times a day for the first five postoperative days. Patients will be evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day. |
| Oral Suspending Vehicle, Ora-Plus | Placebo comparator | Drug: Oral Suspending VehiclePatients in the control arm will receive, in a blinded fashion, 160mg of the placebo orally four times a day for the first five postoperative days. The placebo will be prepared by pharmacy to be identical to the test drug formulation except for being pharmacologically inert. Patients will be evaluated by a trained research assistant on a daily basis while in hospital. Passage of flatus, bowel movements, and postoperative pain will be evaluated at those visits. A two-week, and 30-day phone call to patients discharged from hospital will be done to assess for outcomes after discharge. Follow-up will end after the 30th postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting patients over the age of 18 undergoing elective, abdominal colorectal surgery involving bowel resection with or without re-anastomosis (both open and laparoscopic surgeries) at either the Juravinski Hospital and Cancer Center or St. Joseph's Hospital in Hamilton
Key exclusion criteria (4 listed)
- Patients undergoing emergency surgery
- Documented allergy to simethicone
- Unable to provide informed consent (non-English speaking patients and those with cognitive impairment)
- Patients not having an abdominal operation (ie. perineal procedure)
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 |
|---|---|---|
| SimethiconeAlso: OVOL®Pharmacological category: antiflatulent 160mg Simethicone orally, 4 times a day for the first five postoperative days | Drug | Simethicone, OVOL |
| Oral Suspending VehicleAlso: ORA-Plus®ORA-Plus is an aqueous-based vehicle. Identical to the test drug formulation except for being pharmacologically inert. 160mg Ora-Plus orally, 4 times a day for the first five postoperative days | Drug | Oral Suspending Vehicle, Ora-Plus |
Primary outcome
time to first passage of flatus
Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
passage of flatus (measured in hours) is considered an acceptable sign of the return of gut function and a criterion for discharge from hospital (bowel movement is not)
6 secondary outcomes
time to first bowel movement
Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
length of hospital stay
Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
postoperative pain
Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
postoperative narcotic requirements
Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
incidence of postoperative vomiting
Time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days
incidence of postoperative complications
Time frame: within the first 30 days (plus or minus 3 days) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Background: PubMed 22414412Doorly MG, Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Surg Clin North Am. 2012 Apr;92(2):259-72, viii. doi: 10.1016/j.suc.2012.01.010.
- Background: PubMed 19590205Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.
- Background: PubMed 11755891Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. doi: 10.1016/s0002-9610(01)00781-4.
- Background: PubMed 17909274Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S3-7. doi: 10.2146/ajhp070428.
- Background: PubMed 21730280Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011 Jul;45(7-8):916-23. doi: 10.1345/aph.1Q041. Epub 2011 Jul 5.
- Background: PubMed 15357847Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16. doi: 10.1111/j.1743-3150.2004.00553.x.
- Background: PubMed 15357852Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.
- Background: PubMed 20228654Hocevar BJ, Robinson B, Gray M. Does chewing gum shorten the duration of postoperative ileus in patients undergoing abdominal surgery and creation of a stoma? J Wound Ostomy Continence Nurs. 2010 Mar-Apr;37(2):140-6. doi: 10.1097/WON.0b013e3181d0b92b.
- Background: PubMed 4600627Danhof IE, Stavola JJ. Accelerated transit of intestinal gas with simethicone. Obstet Gynecol. 1974 Jul;44(1):148-54. No abstract available.
- Background: PubMed 4937581Gibstein A, Cooper JJ, Wisot AL, Rosenthal AH. Prevention of postoperative abdominal distention and discomfort with simethicone. Obstet Gynecol. 1971 Sep;38(3):386-90. No abstract available.
- Background: PubMed 17710495Chan MK, Law WL. Use of chewing gum in reducing postoperative ileus after elective colorectal resection: a systematic review. Dis Colon Rectum. 2007 Dec;50(12):2149-57. doi: 10.1007/s10350-007-9039-9.
- Background: PubMed 18722937Forbes SS, Stephen WJ, Harper WL, Loeb M, Smith R, Christoffersen EP, McLean RF. Implementation of evidence-based practices for surgical site infection prophylaxis: results of a pre- and postintervention study. J Am Coll Surg. 2008 Sep;207(3):336-41. doi: 10.1016/j.jamcollsurg.2008.03.014. Epub 2008 May 19.
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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.
Shawn S Forbes, MD, MSc principal investigator
McMaster University
Cagla Eskicioglu, MD, MSc principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simethicone in people with Postoperative Ileus and Ileus, run by McMaster University at 2 sites in Canada.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to first passage of flatus (time frame: participants will be followed for the duration of their hospital stay, an expected average of 7 days). 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 NCT02161367, which also lists 13 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 4 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.