Post-operative IleusPhase 4NCT01662115
Nicotine Gum Recovery After Colorectal Surgery
A Phase 4 study testing Nicotine gum and Regular chewing gum in people with Post-operative Ileus, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-operative Ileus
- What is being tested?
- Nicotine gum and Regular chewing gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2014
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;
Who cannot join
- Prior intestinal surgery
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
- American Society of Anesthesiologists (ASA) Class IV or V;
- History of abdominal carcinomatosis;
- History of radiation enteritis;
- Children < 18 or adults > 85 years of age
Show all 10Show fewer
- Pregnant women
- Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than 3 months ago.
- Patients requiring postoperative ventilation, pressor requirement or ICU stay
- Patients with prior cardiovascular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?
The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.
Read the detailed description
The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.
- Conditions
- Post-operative Ileus
- Being tested
- Nicotine gum, Regular chewing gum
- Keywords
- ILEUS
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine gumDrug
Also called Nicorrete gum
Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
Regular chewing gumOther
Also called Sugarlees chewing gum
Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
| Study group | Role | What they receive |
|---|---|---|
| Nicotine gum | Active comparator | 100 subjects who will actually get the intervention medication Receives: Drug: Nicotine gum |
| regular chewing gum | Sham comparator | 100 subjects who will be part of a control group Receives: Other: Regular chewing gum |
| No gum | No intervention | 100 subjects who will not get neither the intervention nor the placebo gum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Function Recovery
Time to first bowel movement or flatus
Measured: 7 days
Secondary outcomes (3)
Hospital Stay
Length of postoperative hospital stay
Measured: 30 days
Post-operative Vomiting
Episodes of vomiting
Measured: 30 days
Use of NG Tubes
Nasogastric tube (re)insertions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Study has been terminated due linability to recruit the targeted participants. Aimed for 300 participants and only 4 were enrolled after 1 year.
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.
- Other trials for Post-operative IleusStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Weiss, The Cleveland Clinic
- Investigators
- ERIC G WEISS, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662115
- Sponsor's protocol ID
- CRS-2012-05
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2012
- Last updated
- 22 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?
- ClinicalTrials.gov ID
- NCT01662115
- Acronym / sponsor ID
- CRS-2012-05
- Conditions
- Post-operative Ileus
- Keywords
- ILEUS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated due linability to recruit the targeted participants. Aimed for 300 participants and only 4 were enrolled after 1 year.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 22 Aug 2017
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 evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.
Detailed description
The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine gum | Active comparator | Drug: Nicotine gum100 subjects who will actually get the intervention medication |
| regular chewing gum | Sham comparator | Other: Regular chewing gum100 subjects who will be part of a control group |
| No gum | No intervention | –100 subjects who will not get neither the intervention nor the placebo gum. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Due to undergo small and/or large partial bowel resection via laparotomy or laparoscopy;
Key exclusion criteria (10 listed)
- Prior intestinal surgery
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures
- American Society of Anesthesiologists (ASA) Class IV or V;
- History of abdominal carcinomatosis;
- History of radiation enteritis;
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 |
|---|---|---|
| Nicotine gumAlso: Nicorrete gumPatients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first | Drug | Nicotine gum |
| Regular chewing gumAlso: Sugarlees chewing gumPatients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first | Other | regular chewing gum |
Primary outcome
Bowel Function Recovery
Time frame: 7 days
Time to first bowel movement or flatus
3 secondary outcomes
Hospital Stay
Time frame: 30 days
Post-operative Vomiting
Time frame: 30 days
Use of NG Tubes
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Post-operative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
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.
ERIC G WEISS, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine gum and Regular chewing gum in people with Post-operative Ileus, run by The Cleveland Clinic 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 2 inclusion and 10 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 22 Aug 2017. 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.
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?
Yes. Results are posted in the registry (first posted 22 Aug 2017). 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?
Bowel Function Recovery (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017.