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Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

Primary Purpose

Complications, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Void
Sponsored by
Syed Husain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

SOC Voiding Protocol

No Void Intervention

Arm Description

Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home.

Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.

Outcomes

Primary Outcome Measures

Post-Operative Phone Call
Assess readmissions

Secondary Outcome Measures

PACU times
Assess time spent in PACU

Full Information

First Posted
May 24, 2018
Last Updated
April 12, 2021
Sponsor
Syed Husain
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1. Study Identification

Unique Protocol Identification Number
NCT03812536
Brief Title
Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
Official Title
Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Syed Husain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SOC Voiding Protocol
Arm Type
No Intervention
Arm Description
Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home.
Arm Title
No Void Intervention
Arm Type
Experimental
Arm Description
Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.
Intervention Type
Other
Intervention Name(s)
No Void
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-Operative Phone Call
Description
Assess readmissions
Time Frame
30 days
Secondary Outcome Measure Information:
Title
PACU times
Description
Assess time spent in PACU
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Diaz, MCR
Phone
614-293-8549
Email
kayla.diaz@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amen An
Phone
614-293-9964
Email
amen.an@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Husain, MBBS
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Diaz, BA

12. IPD Sharing Statement

Plan to Share IPD
No

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Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

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