Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

Complications, Postoperative Clinical Trial

Official title:

Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812536
• Other study ID #: 2018H0208
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Complications, Postoperative
• Postoperative Complications

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