Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

April 1, 2025 updated by: Syed Husain
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: No Void Intervention
Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PACU Time
Time Frame: 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.
This measure will be recorded through the study period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Readmission
Time Frame: 30 days
Number of patients readmitted in the 30-days period after surgery
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syed Husain

Investigators

  • Principal Investigator: Syed Husain, MBBS, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

August 7, 2020

Study Completion (Actual)

August 7, 2020

Study Registration Dates

First Submitted

May 24, 2018

First Submitted That Met QC Criteria

January 19, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018H0208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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