Trial Outcomes & Findings for Nicotine Gum Recovery After Colorectal Surgery (NCT NCT01662115)
NCT ID: NCT01662115
Last Updated: 2017-08-22
Results Overview
Time to first bowel movement or flatus
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
7 days
Results posted on
2017-08-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nicotine Gum
n=2 Participants
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
|
Regular Chewing Gum
n=2 Participants
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
58 years
n=2 Participants
|
66 years
n=2 Participants
|
—
|
62 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
—
|
3 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
—
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 daysTime to first bowel movement or flatus
Outcome measures
| Measure |
Nicotine Gum
n=2 Participants
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
|
Regular Chewing Gum
n=2 Participants
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Bowel Function Recovery
|
4 days
Interval 3.0 to 5.0
|
5 days
Interval 4.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: 30 daysLength of postoperative hospital stay
Outcome measures
| Measure |
Nicotine Gum
n=2 Participants
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
|
Regular Chewing Gum
n=2 Participants
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Hospital Stay
|
7 days
Interval 5.0 to 9.0
|
8 days
Interval 7.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: 30 daysEpisodes of vomiting
Outcome measures
| Measure |
Nicotine Gum
n=2 Participants
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
|
Regular Chewing Gum
n=2 Participants
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Post-operative Vomiting
|
0 vomiting episodes
Interval 0.0 to 0.0
|
0 vomiting episodes
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: 30 daysNasogastric tube (re)insertions
Outcome measures
| Measure |
Nicotine Gum
n=2 Participants
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
|
Regular Chewing Gum
n=2 Participants
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Use of NG Tubes
|
0 NG Tubes use
Interval 0.0 to 0.0
|
1 NG Tubes use
Interval 0.0 to 1.0
|
—
|
Adverse Events
Nicotine Gum
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Regular Chewing Gum
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
No Gum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nicotine Gum
n=2 participants at risk
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
|
Regular Chewing Gum
n=2 participants at risk
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Gastrointestinal disorders
Prolonged hospital stay
|
50.0%
1/2 • Number of events 1 • 30 days after procedure
|
50.0%
1/2 • Number of events 1 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
Other adverse events
| Measure |
Nicotine Gum
n=2 participants at risk
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
|
Regular Chewing Gum
n=2 participants at risk
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
|
No Gum
100 subjects who will not get neither the intervention nor the placebo gum.
|
|---|---|---|---|
|
Infections and infestations
Wound Infection
|
50.0%
1/2 • Number of events 1 • 30 days after procedure
|
0.00%
0/2 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 2 • 30 days after procedure
|
0.00%
0/2 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
|
Metabolism and nutrition disorders
Low creatinine level
|
50.0%
1/2 • Number of events 3 • 30 days after procedure
|
50.0%
1/2 • Number of events 3 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • Number of events 2 • 30 days after procedure
|
50.0%
1/2 • Number of events 2 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1 • 30 days after procedure
|
50.0%
1/2 • Number of events 1 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
|
Metabolism and nutrition disorders
Hyperglicemia
|
50.0%
1/2 • Number of events 5 • 30 days after procedure
|
100.0%
2/2 • Number of events 6 • 30 days after procedure
|
—
0/0 • 30 days after procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place