Dehydration, Diverting Ileostomy, Loperamide
Conditions
Brief summary
Dehydration post creation of a diverting ileostomy is a common and debilitating problem faced by patients undergoing ileal-anal pouch anastomoses for both inflammatory bowel disease and familial adenomatous polyposis (FAP) syndrome. Those patients with low rectal cancers or other polyposis syndromes e.g. HNPCC hereditary non polyposis colorectal cancers, may potentially have a delay in the adjuvant therapy when faced with this complication. Studies performed in this groups of patients report a readmission rate of 17-21% for dehydration. Loperamide has been shown to significantly decrease the daily volume of weight of stool in these patients. The purpose of this study is to establish whether loperamide given at 4mg three times daily for 14 days from day of discharge empirically decreases 30 days readmission rate for dehydration. The investigators hypothesize that there will be a 15% decrease from 25% to 10% in the readmission rates, that severity of dehydration will be decreased.
Interventions
DRUGLoperamide
Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form; 2. Males or females, age 18 and older at the time of study screening; 3. American Society of Anesthesiologists (ASA) Class I-III (Appendix III) undergoing elective surgery
Exclusion criteria
1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures 2. American Society of Anesthesiologists (ASA) Class IV or V; emergency surgeries 3. Children \<18 4. Pregnant patients 5. Patients who have intra-abdominal sepsis or partial or intermittent bowel obstruction or enteritis 6. Patients who are on long term steroids, opioids or antidiarrheals pre operatively 7. Patients who are administered pro kinetics eg. Metoclopramide 8. Patients with recurrent disease in their small bowel - Crohn's disease, or previous irradiated pelvis resulting in irradiation bowel disease 9. End ileostomies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of 30 Day Readmission (Severe Dehydration) | 30 day |
Secondary
| Measure | Time frame |
|---|---|
| Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission | 30 day |
| Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care | 30 days |
Other
| Measure | Time frame |
|---|---|
| Length of Index Admission | 30 day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control No intervention | 0 |
| Therapeutic Patients randomized to this arm will be administered 4mg tid (three times daily) of loperamide from the day of discharge onwards. A total of duration of 14 days of medication will be administered
Loperamide: Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 22 | 18 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of 30 Day Readmission (Severe Dehydration)
Time frame: 30 day
Population: Data was not collected.
Secondary
Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care
Time frame: 30 days
Population: Data was not collected.
Secondary
Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission
Time frame: 30 day
Population: Data was not collected.
Other Pre-specified
Length of Index Admission
Time frame: 30 day
Population: Data was not collected.