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Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

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University of Tennessee

Status

Enrolling

Conditions

Urinary Complication
Patient Discharge

Treatments

Procedure: Backfill

Study type

Interventional

Funder types

Other

Identifiers

NCT06737393
24-09979-FB

Details and patient eligibility

About

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

Full 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.

Enrollment

112 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

112 participants in 2 patient groups

Backfill
Experimental group
Description:
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.
Treatment:
Procedure: Backfill
No bladder filling
No Intervention group
Description:
Participants will have the Foley catheter removed intraoperatively at completion of the procedure.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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