Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2018
CompletedStudy Start
First participant enrolled
June 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2020
CompletedResults Posted
Study results publicly available
March 27, 2025
CompletedApril 13, 2025
April 1, 2025
2.1 years
May 24, 2018
April 19, 2022
April 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (1)
30-day Readmission
30 days
Study Arms (2)
SOC Voiding Protocol
NO INTERVENTIONPatients 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
EXPERIMENTALPatients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18-80 years old
- Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syed Husainlead
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Syed Husain
- Organization
- Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Syed Husain, MBBS
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor - Colon and Rectal Surgery
Study Record Dates
First Submitted
May 24, 2018
First Posted
January 23, 2019
Study Start
June 19, 2018
Primary Completion
August 7, 2020
Study Completion
August 7, 2020
Last Updated
April 13, 2025
Results First Posted
March 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share