Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

Not Applicable

Recruiting

• Conditions: Patient Discharge; Urinary Complication

• Registration Number: NCT06737393
• Lead Sponsor: University of Tennessee

Brief Summary

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

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-12-15
• Last Update Submitted: 2024-12-15
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to discharge	Within 3 days following surgery	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.

Secondary Outcome Measures

Name	Time	Method
Time to void	Within 3 days following surgery	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.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States