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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03812536
Other study ID # 2018H0208
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 19, 2018
Est. completion date June 1, 2022

Study information

Verified date April 2021
Source Ohio State University
Contact Kayla Diaz, MCR
Phone 614-293-8549
Email kayla.diaz@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Syed Husain

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-Operative Phone Call Assess readmissions 30 days
Secondary PACU times Assess time spent in PACU 24 hours
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