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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05108506
Other study ID # IRB00307084
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2022
Est. completion date April 1, 2024

Study information

Verified date April 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date April 1, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
No Strict need to void following surgery
Certain patient will be randomized without a strict need to void prior to discharge following surgery.
Strict need to void following surgery
Certain patient will be randomized with a strict need to void prior to discharge following surgery.

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of urinary retention Will measure rates of urinary retention. 2 years
Primary Rates of UTI Will measure rates of UTI. 2 years
Primary Rates of re-presentation to the ER Will measure rates of re-presentation to ER. 2 years
Secondary Amount of time spent in PACU This will assess the amount of time spent (in hours) in PACU. 2 years
Secondary Cost of stay in PACU 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. 2 years
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