Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

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: Recruiting
• Conditions: Complications, Postoperative
• Intervention / Treatment: Other: No Void

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 (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayla Diaz, MCR; Phone Number: 614-293-8549; Email: kayla.diaz@osumc.edu
• Study Contact Backup: Name: Amen An; Phone Number: 614-293-9964; Email: amen.an@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Kayla Diaz, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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
Post-Operative Phone Call	Assess readmissions	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU times	Assess time spent in PACU	24 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

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 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• 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