Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery

NCT ID: NCT03812536

Last Updated: 2025-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-19

Study Completion Date

2020-08-07

Brief Summary

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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

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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.

Conditions

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Complications, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

No Void Intervention

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

Group Type EXPERIMENTAL

No Void

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syed Husain

OTHER

Sponsor Role lead

Responsible Party

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Syed Husain

Assistant Professor - Colon and Rectal Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Syed Husain, MBBS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2018H0208

Identifier Type: -

Identifier Source: org_study_id

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