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Another study published with similar results
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Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a variety of ailments. These procedures often require that the bladder be filled and emptied with sterile water or saline several times during the procedure, and often result in the patient receiving a catheter at the end of the procedure. One common side effect is that patients experience bladder spasm or discomfort for a period of time after these procedures. Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the post-operative setting to relieve these symptoms.
The principle objectives of this study are:
The patients will be divided into three research arms. Patients will be randomly selected for one of the groups using a random number generator between 1 and 3. There will be a "Control Group" which will receive a rectal exam while still in the operating room in the lithotomy position after the procedure. There will be a "Postoperative OR" group which will receive a B and O suppository while still in the operating room in the lithotomy position after the procedure. Finally, there will be a "Preoperative OR" group which will receive a B and O suppository after the induction of anesthesia prior to beginning the urologic procedure in the lithotomy position. The "Control Group" will receive a rectal exam in the operating room after the procedure but before extubation to simulate the effects of suppository administration so that the investigators know that any effects are due to the medication and not to the placement of the suppository itself. Those patients in the "control group" may receive a B and O suppository as part of standard procedure in the post-operative period if these individuals experience any bladder spasms and wish to have this as a treatment. This administration will be at the discretion of the operating surgeon as it is in standard cases. Patients may also receive Ditropan in the post-operative setting, which is part of the standard procedure for treating bladder spasms following urologic procedures. Patients in the postoperative and preoperative OR groups will be offered Ditropan for any bladder spasms in the post-operative setting to control symptoms, which is part of the normal standard of care for anyone who has already received a B and O suppository with inadequate control of symptoms. All patients will be treated with a normal post-operative pain regimen which may include narcotics. This will be at the discretion of the treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative Suppository | Experimental | A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery. |
|
| Post-operative Suppository | Active Comparator | A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery. |
|
| Rectal Exam | Placebo Comparator | Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belladonna and Opium Suppository | Drug |
| ||
| Rectal Exam |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Morphine Equivalent Dose | No results collected on the post-operative morphine equivalent dose | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10 | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Mufarrij | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-operative Suppository | A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery. Belladonna and Opium Suppository |
| FG001 | Post-operative Suppository | A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery. Belladonna and Opium Suppository |
| FG002 | Rectal Exam | Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. Rectal Exam |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We did not collect the data on any of these patients. Therefore there is no data on ethnicity, age, or sex.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-operative Suppository | A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery. Belladonna and Opium Suppository |
| BG001 | Post-operative Suppository |
| 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 | Post-operative Morphine Equivalent Dose | No results collected on the post-operative morphine equivalent dose | Study terminated prior to results. | Posted | 24 hours |
|
Adverse Data collected over 2 months while study was recruiting patients. No adverse events recorded.
No adverse events were reported.
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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 | Pre-operative Suppository | A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery. Belladonna and Opium Suppository |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Patrick Mufarrij | George Washington University | 2027154000 | pmufarrij@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2016 | Dec 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Procedure |
|
A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.
Belladonna and Opium Suppository
| BG002 | Rectal Exam | Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. Rectal Exam |
| BG003 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Participants |
| Rectal Exam |
Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. Rectal Exam |
|
| Secondary | Post-Operative Pain | Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10 | Data was not collected on these patients. | Posted | 24 hours |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Post-operative Suppository | A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery. Belladonna and Opium Suppository | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Rectal Exam | Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo. Rectal Exam | 0 | 7 | 0 | 7 | 0 | 7 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |