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Post Hysterectomy Benefits of Retained Cystoscopy Fluid

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University of Arizona

Status

Completed

Conditions

Urinary Retention

Treatments

Procedure: Retained fluid
Procedure: Emptied fluid

Study type

Interventional

Funder types

Other

Identifiers

NCT03646136
UA IRB# 1808885089

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

120 participants in 2 patient groups

Retained Cystoscopy Fluid
Experimental group
Description:
Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy
Treatment:
Procedure: Retained fluid
Cystoscopy Fluid Emptied
Active Comparator group
Description:
Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy
Treatment:
Procedure: Emptied fluid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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