Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy

Not Applicable

Completed

• Conditions: Urinary Retention Postoperative

• Registration Number: NCT05108506
• Lead Sponsor: Johns Hopkins University

Brief Summary

Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.

To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-05
• Study Start: 2022-12-05
• Primary Completion: 2024-03-30
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

Inclusion Criteria

• Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
• English speaking

Exclusion Criteria

• At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
• Any patient with a history of prior urologic procedures
• Patients with any baseline known urinary disease
• Any bladder injury at the time of surgery
• Any combined cases with other surgical services
• Patients undergoing surgery for prolapse or incontinence symptoms
• Patients who are ultimately not discharged the same day and remain in house overnight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Amount of time spent in PACU	2 years	This will assess the amount of time spent (in hours) in PACU.

Secondary Outcome Measures

Name	Time	Method
Rates of urinary retention	2 years	Will measure rates of urinary retention.
Rates of UTI	2 years	Will measure rates of UTI.
Rates of re-presentation to the ER	2 years	Will measure rates of re-presentation to ER.
Cost of stay in PACU	2 years	This will assess the cost pertaining to the time spent in the PACU to determine if the time spent has a significant impact on the cost.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States