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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Therapeutic | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loperamide | Drug | Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 30 Day Readmission (Severe Dehydration) | 30 day |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Index Admission | 30 day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip R Fleshner, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No intervention |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data was not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No intervention |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Incidence of 30 Day Readmission (Severe Dehydration) | Data was not collected. | Posted | 30 day |
|
|
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Data was not collected. Study was terminated prematurely due to issued with compliance. Total number of participants at Risk (e.g., " All-Cause Mortality, Serious, and other [not including serious] adverse events were not monitored/assessed for this study.
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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 | Control | No intervention | 0 |
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Study only accrued 40 patients. Due to issues with enrollment and study procedures compliance it was decided to terminate the study. Data analysis will not be done for this study. This study has been closed with the internal review board.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Fleshner, MD | Cedars Sinai Medical Center | 310-289-9224 | pfleshner@aol.com |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008139 | Loperamide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Participants |
|
| Secondary | Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission | Data was not collected. | Posted | 30 day |
|
|
| Secondary | Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care | Data was not collected. | Posted | 30 days |
|
|
| Other Pre-specified | Length of Index Admission | Data was not collected. | Posted | 30 day |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
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| D013568 | Pathological Conditions, Signs and Symptoms |