Complications, Postoperative
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo 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.
Sponsors
Syed Husain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years old * Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision
Exclusion criteria
* Age \< 18 yo or \> 80 yo * Prisoners * Pregnant Women * Unable or unwilling to follow the study protocol or any reason the research team believes the subject is not appropriate candidate for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PACU Time | This measure will be recorded through the study period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Readmission | 30 days | Number of patients readmitted in the 30-days period after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 56 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | SOC Voiding Protocol | No Void Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 53 Participants | 94 Participants |
| Age, Continuous | 42 years | 41 years | 42 years |
| Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia Condyloma | 13 Participants | 15 Participants | 28 Participants |
| Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia Exam Under Anesthesia | 14 Participants | 16 Participants | 30 Participants |
| Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia Fistulotomy | 10 Participants | 19 Participants | 29 Participants |
| Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia Hemorrhoidectomy | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized African American | 5 Participants | 12 Participants | 17 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 36 Participants | 41 Participants | 77 Participants |
| Region of Enrollment United States | 44 participants | 56 participants | 100 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 26 Participants | 39 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 56 |
| other Total, other adverse events | 0 / 44 | 0 / 56 |
| serious Total, serious adverse events | 0 / 44 | 0 / 56 |
Outcome results
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.
Time frame: This measure will be recorded through the study period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC Voiding Protocol | PACU Time | 129.1 Minutes | Standard Deviation 100 |
| No Void Intervention | PACU Time | 210.0 Minutes | Standard Deviation 175 |
Secondary
30-day Readmission
Number of patients readmitted in the 30-days period after surgery
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC Voiding Protocol | 30-day Readmission | 0 Participants |
| No Void Intervention | 30-day Readmission | 0 Participants |