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The objective of this study is to assess if not requiring patients to spontaneous void prior to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of stay in the post-anesthesia care unit without increasing hospital readmissions or emergency room visits.
This study will be a prospective clinical trial, in which 100 anorectal surgery patients will be randomly assigned to a control (spontaneous void) or experimental (no void group). The spontaneous void group will include 50 patients who will be required to void spontaneously after anorectal surgeries. The no void group will be 50 patients who will be discharged home from the PACU once they meet ambulatory surgery center discharge criteria per hospital guidelines. Patients requiring anorectal surgeries will be consented to take part in the study during the preoperative outpatient office visit. A post-operative phone call will be made by designated study personnel to participants on post-op day 30 using a study questionnaire to assess re-admission and emergency room visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC Voiding Protocol | No Intervention | Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home. | |
| No Void Intervention | Experimental | Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Void | Other | Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| PACU Time | This is the time patients in each arm spend in recovery. Measured as minutes elapsed between the end of surgery (surgery end time) and discharge from recovery room. | This measure will be recorded through the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Readmission | Number of patients readmitted in the 30-days period after surgery | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syed Husain, MBBS | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC Voiding Protocol | Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home. |
| FG001 | No Void Intervention | Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously. No Void: Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients undergoing ambulatory surgeries for 1. Hemorrhoids, 2. Anal fistula and 3. Anal Condyloma.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOC Voiding Protocol | Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home. |
| BG001 | No Void Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | PACU Time | This is the time patients in each arm spend in recovery. Measured as minutes elapsed between the end of surgery (surgery end time) and discharge from recovery room. | Posted | Mean | Standard Deviation | Minutes | This measure will be recorded through the study period. |
|
30 days.
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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 | SOC Voiding Protocol | Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Syed Husain | Ohio State University | 6142938772 | syed.husain@osumc.edu |
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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 | May 31, 2018 | Apr 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2018 | Apr 17, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.
No Void: Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia | Count of Participants | Participants |
|
|
|
| Secondary | 30-day Readmission | Number of patients readmitted in the 30-days period after surgery | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | No Void Intervention | Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously. No Void: Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria. | 0 | 56 | 0 | 56 | 0 | 56 |
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