Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: a Randomized Controlled Trial

The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit.

Study Overview

• Status: Recruiting
• Conditions: Patient Discharge; Urinary Complication
• Intervention / Treatment: Procedure: Backfill

Detailed Description

This is a prospective, single-blinded, randomized clinical trials in which patients undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to have the bladder backfilled at the completion of the surgery prior to Foley catheter removal. If the patient is assigned to group A, 200 mL of room temperature, sterile normal saline will be instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. If the patient is assigned to group B, the Foley catheter will be removed intraoperatively at completion of the procedure. The standard protocol is to use a 16F Foley catheter for gynecologic laparoscopy cases, and patients in both groups will receive the same size catheter. After surgery, time to discharge and time to void will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • University of Tennessee Health Science Center
      • Contact: Amira Wohabrebbi, PhD; Phone Number: 901-545-7453; Email: awohabre@uthsc.edu
      • Contact: Annette Hickerson, RN; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
      • Principal Investigator: John O Schorge, MD
      • Sub-Investigator: Emma Ryan, BS
      • Sub-Investigator: Alex Samborski, MD
      • Sub-Investigator: Riley Short, MD
      • Sub-Investigator: Hunter R Harrison, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women aged 18 to 80
• Undergoing planned laparoscopic hysterectomy as a day surgery procedure

Exclusion Criteria:

• Women younger than 18 or older than 80 years of age
• Undergoing a non-laparoscopic unplanned surgical procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Backfill; Participants will receive 200 mL of room temperature, sterile normal saline instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively.	Procedure: Backfill; Participants undergoing laparoscopic hysterectomy have the bladder filled with 200 mL saline prior to Foley removal at the end of surgery.
No Intervention: No bladder filling; Participants will have the Foley catheter removed intraoperatively at completion of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	The time to discharge for each participant, which will be defined as the length of time from surgery completion to discharge from the post-anesthesia care unit, will be recorded.	Within 3 days following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to void	The time to void for each participant, which will be defined as the length of time from surgery completion to the time of participant's first voiding event, will be recorded.	Within 3 days following surgery

Collaborators and Investigators

• Sponsor: University of Tennessee

Publications and helpful links

General Publications

• Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
• Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.
• Chao L, Mansuria S. Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):879-887. doi: 10.1097/AOG.0000000000003191.
• Hariati H, Suza DE, Tarigan R. Risk Factors Analysis for Catheter-Associated Urinary Tract Infection in Medan, Indonesia. Open Access Maced J Med Sci. 2019 Sep 12;7(19):3189-3194. doi: 10.3889/oamjms.2019.798. eCollection 2019 Oct 15.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 24-09979-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No