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Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

NCT ID: NCT06737393

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Patient Discharge Urinary Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Backfill

Intervention Type PROCEDURE

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

No bladder filling

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Backfill

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Amira Wohabrebbi, PhD

Role: primary

Annette Hickerson, RN

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 30969209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17980330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22984818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31949514 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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24-09979-FB

Identifier Type: -

Identifier Source: org_study_id