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Study has been terminated due linability to recruit the targeted participants. Aimed for 300 participants and only 4 were enrolled after 1 year.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine gum | Active Comparator | 100 subjects who will actually get the intervention medication |
|
| regular chewing gum | Sham Comparator | 100 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine gum | Drug | Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Function Recovery | Time to first bowel movement or flatus | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Stay | Length of postoperative hospital stay | 30 days |
| Post-operative Vomiting | Episodes of vomiting | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ERIC G WEISS, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Gum | 100 subjects who will actually get the intervention medication Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first |
| FG001 | Regular Chewing Gum | 100 subjects who will be part of a control group Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first |
| FG002 | No Gum | 100 subjects who will not get neither the intervention nor the placebo gum. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Gum | 100 subjects who will actually get the intervention medication Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first |
| BG001 | Regular Chewing Gum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bowel Function Recovery | Time to first bowel movement or flatus | Posted | Mean | Full Range | days | 7 days |
|
30 days after procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Gum | 100 subjects who will actually get the intervention medication Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged hospital stay | Gastrointestinal disorders | Systematic Assessment | Post-operative ileus |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Infection | Infections and infestations | Systematic Assessment |
Principal Investigator decided for an early termination of the enrollment period due to small numbers of subjects consented, with limited data to make conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Academic Office | Cleveland Clinic Florida | 9546595278 | weisse@ccf.org |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Regular chewing gum | Other | Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first |
|
|
| Use of NG Tubes | Nasogastric tube (re)insertions | 30 days |
100 subjects who will be part of a control group
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
| BG002 | No Gum | 100 subjects who will not get neither the intervention nor the placebo gum. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
100 subjects who will not get neither the intervention nor the placebo gum. |
|
|
| Secondary | Hospital Stay | Length of postoperative hospital stay | Posted | Mean | Full Range | days | 30 days |
|
|
|
| Secondary | Post-operative Vomiting | Episodes of vomiting | Posted | Mean | Full Range | vomiting episodes | 30 days |
|
|
|
| Secondary | Use of NG Tubes | Nasogastric tube (re)insertions | Posted | Mean | Full Range | NG Tubes use | 30 days |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | Regular Chewing Gum | 100 subjects who will be part of a control group Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first | 0 | 2 | 1 | 2 | 2 | 2 |
| EG002 | No Gum | 100 subjects who will not get neither the intervention nor the placebo gum. | 0 | 0 | 0 | 0 | 0 | 0 |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Low creatinine level | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglicemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| >=65 years |
|