Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

NCT06737393 | Recruiting

• 1 other identifier: 24-09979-FB
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Discharge; Urinary Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to void

  Within 3 days following surgery

Study Arms (2)

Backfill

EXPERIMENTAL

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

No bladder filling

NO INTERVENTION

Participants will have the Foley catheter removed intraoperatively at completion of the procedure.

Interventions

Backfill PROCEDURE

Participants undergoing laparoscopic hysterectomy have the bladder filled with 200 mL saline prior to Foley removal at the end of surgery.

Backfill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women who are biologically female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 30969209 BACKGROUND

• 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.

  PMID: 17980330 BACKGROUND

• 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.

  PMID: 22984818 BACKGROUND

• 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.

  PMID: 31949514 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: December 17, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)