Clinical trial NCT03646136: Post Hysterectomy Benefits of Retained Cystoscopy Fluid
Official title: Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to spontaneous void
timeFrame: From surgery end time up to 4 hours
Secondary outcomes:
measure: Foley catheter insertion rate
timeFrame: 2 weeks
measure: Length of recovery room stay
timeFrame: From time of randomization up to 12 hours postoperative
measure: 4-Item Patient Satisfaction Measure
timeFrame: 12 hours
measure: 2-Item Patient Satisfaction Measure
timeFrame: 24 hours
measure: 3-Item Bladder Symptoms Measure
timeFrame: 24 hours
measure: 2-Item Bladder pain Measure
timeFrame: 12 hours
measure: 3-Item Bladder pain Measure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix
name: Rachael Smith, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
citation: Smith RB, Mahnert ND, Hu C, Steck-Bayat K, Womack AS, Mourad J. Impact of Retained Cystoscopy Fluid after Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Feb;28(2):288-296. doi: 10.1016/j.jmig.2020.05.024. Epub 2020 Jun 4.