Post-operative Ileus
Conditions
Keywords
ILEUS
Brief 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.
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.
Interventions
DRUGNicotine gum
Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
OTHERRegular chewing gum
Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Function Recovery | 7 days | Time to first bowel movement or flatus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay | 30 days | Length of postoperative hospital stay |
| Post-operative Vomiting | 30 days | Episodes of vomiting |
| Use of NG Tubes | 30 days | Nasogastric tube (re)insertions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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 | 2 |
| No Gum 100 subjects who will not get neither the intervention nor the placebo gum. | 0 |
| Total | 4 |
Baseline characteristics
| Characteristic | Regular Chewing Gum | Total | Nicotine Gum |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Continuous | 66 years | 62 years | 58 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 0 / 0 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 | 0 / 0 |
Outcome results
Primary
Bowel Function Recovery
Time to first bowel movement or flatus
Time frame: 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nicotine Gum | Bowel Function Recovery | 4 days |
| Regular Chewing Gum | Bowel Function Recovery | 5 days |
Secondary
Hospital Stay
Length of postoperative hospital stay
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nicotine Gum | Hospital Stay | 7 days |
| Regular Chewing Gum | Hospital Stay | 8 days |
Secondary
Post-operative Vomiting
Episodes of vomiting
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nicotine Gum | Post-operative Vomiting | 0 vomiting episodes |
| Regular Chewing Gum | Post-operative Vomiting | 0 vomiting episodes |
Secondary
Use of NG Tubes
Nasogastric tube (re)insertions
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nicotine Gum | Use of NG Tubes | 0 NG Tubes use |
| Regular Chewing Gum | Use of NG Tubes | 1 NG Tubes use |