Purpose

The purpose of this research study is to compare outcomes for women in two study arms that include retaining the cystoscopy distending fluid after minimally invasive hysterectomy verses completely emptying the cystoscopy distending fluid. The outcomes being measured for research purposes include the time spent to first spontaneous urination after surgery, rate of indwelling catheter insertion, length of recovery room stay, the amount of bladder discomfort immediately postoperative and over the first 24 hours postoperative, bladder symptoms over the first 24 hours postoperative, and patient satisfaction.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Female patients, greater than or equal to 18 years old
  • English-speaking
  • Undergoing laparoscopic or robotic hysterectomy for benign indications by one of the three minimally invasive gynecologic surgeons at Banner University Medical Center - Phoenix.

Exclusion Criteria

  • Preoperative indications of pelvic organ prolapse
  • Preoperative indications of urinary incontinence
  • Lower urologic (bladder or ureteric) injury identified at time of hysterectomy or during intraoperative cystoscopy
  • Patients given any measure to aid in visualization of ureteral patency including dextrose, phenazopyridine, indigo carmine, methylene blue, sodium fluorescein, or furosemide.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Other
Masking
Single (Care Provider)
Masking Description
PACU nurses and patients will not be aware of which arm patient was randomized to.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Retained Cystoscopy Fluid
Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy
  • Procedure: Retained fluid
    Retained fluid
Active Comparator
Cystoscopy Fluid Emptied
Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy
  • Procedure: Emptied fluid
    Emptied fluid

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Regina Montero, MSN
480-239-8697
rmontero@email.arizona.edu

More Details

NCT ID
NCT03646136
Status
Recruiting
Sponsor
University of Arizona

Study Contact

Regina Montero, MSN
480-239-8697
rmontero52@email.arizona.edu

Detailed Description

Acute urinary retention can be a common postoperative complication following hysterectomy. One of the many benefits of minimally invasive surgery is shorter hospital stay following a major procedure such as laparoscopic or robotic hysterectomy. An important postoperative milestone before discharge from the postoperative anesthesia care unit (PACU) is spontaneous voiding. If unable to spontaneously void due to urinary retention, insertion of an indwelling catheter may be required. Awaiting a spontaneous void in the recovery room can lead to longer hospital and PACU stays, greater cost, and patient dissatisfaction. At the conclusion of traditional laparoscopic or robotic-assisted hysterectomy, intraoperative cystoscopy is performed to evaluate for urologic injury. One possible strategy to more quickly facilitate a postoperative spontaneous void is to retain the cystoscopy distending fluid at conclusion of cystoscopy rather than emptying the bladder of the distending fluid. Although there is no published research investigating voiding time following laparoscopic or robotic hysterectomy using strategies such as backfilling the bladder before removal of the indwelling catheter or retaining the cystoscopy distending fluid following diagnostic cystoscopy.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.