Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

Syed Husain

Status: Completed

Conditions: Complications, Postoperative

Treatments: Other: No Void

Study type: Interventional

Funder types: Other

Identifiers

NCT03812536

2018H0208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

SOC Voiding Protocol

No Intervention group

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.

No Void Intervention

Experimental group

Description:

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

Treatment:

Other: No Void