Trial Outcomes & Findings for Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery (NCT NCT03812536)
NCT ID: NCT03812536
Last Updated: 2025-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
This measure will be recorded through the study period.
Results posted on
2025-04-13
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
57
|
|
Overall Study
COMPLETED
|
44
|
56
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
Baseline characteristics by cohort
| Measure |
SOC Voiding Protocol
n=44 Participants
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
n=56 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
n=5 Participants
|
41 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
56 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia
Hemorrhoidectomy
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia
Fistulotomy
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia
Exam Under Anesthesia
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Disease Condition 1. Hemorrhoids. 2. Fistula. 3. Anal Condyloma 4. Exam Under Anesthesia
Condyloma
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SOC Voiding Protocol
n=44 Participants
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
n=56 Participants
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.
|
|---|---|---|
|
PACU Time
|
129.1 Minutes
Standard Deviation 100.0
|
210.0 Minutes
Standard Deviation 175.0
|
SECONDARY outcome
Timeframe: 30 daysNumber of patients readmitted in the 30-days period after surgery
Outcome measures
| Measure |
SOC Voiding Protocol
n=44 Participants
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
n=56 Participants
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.
|
|---|---|---|
|
30-day Readmission
|
0 Participants
|
0 Participants
|
Adverse Events
SOC Voiding Protocol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Void Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place