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Post Hysterectomy Benefits of Retained Cystoscopy Fluid

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ClinicalTrials.gov Identifier: NCT03646136
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rachael Bailey Smith, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Urinary Retention Procedure: Retained fluid Procedure: Emptied fluid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Care Provider)
Masking Description: PACU nurses and patients will not be aware of which arm patient was randomized to.
Primary Purpose: Other
Official Title: Benefits of Retained Cystoscopy Fluid Following Benign Laparoscopic and Robotic Hysterectomy; A Randomized Controlled Trial
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Time to spontaneous void [ Time Frame: From surgery end time up to 4 hours ]
    Measure of time to spontaneous urination in the recovery room post hysterectomy. Time of urination is measured by the recovery room nurse from surgery end time.


Secondary Outcome Measures :
  1. Foley catheter insertion rate [ Time Frame: 2 weeks ]
    Rate of patient's requiring Foley catheter insertion post hysterectomy if unable to spontaneously void in recovery room or anytime within 2 weeks postoperative.

  2. Length of recovery room stay [ Time Frame: From time of randomization up to 12 hours postoperative ]
    Measure of time from surgery end time to discharge home from the recovery room post hysterectomy.

  3. 4-Item Patient Satisfaction Measure [ Time Frame: 12 hours ]
    Self reported patient satisfaction survey related to ability to urinate in the recovery room, amount of time given to urinate, amount of time it took to urinate, and overall bladder discomfort. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).

  4. 2-Item Patient Satisfaction Measure [ Time Frame: 24 hours ]
    Self reported patient satisfaction survey related to voiding function over 24 hours and overall bladder discomfort over 24 hours. Each item is scored 1-5 (1=very satisfied, 5=very dissatisfied).

  5. 3-Item Bladder Symptoms Measure [ Time Frame: 24 hours ]
    Self reported bladder symptom measure of burning, frequency, and urgency with voiding over the 24 hours postoperative. Measured as Yes/No.

  6. 2-Item Bladder pain Measure [ Time Frame: 12 hours ]
    Self reported bladder pain intensity on initial arrival to the recovery room and at discharge from the recovery room. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).

  7. 3-Item Bladder pain Measure [ Time Frame: 24 hours ]
    Self reported bladder pain intensity over 24 hours postoperative, bladder discomfort before urination, and bladder discomfort after urination. Each item is scored 1-10 (1=no discomfort, 10=most discomfort).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing minimally invasive hysterectomy.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646136


Contacts
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Contact: Regina Montero, MSN 480-239-8697 rmontero52@email.arizona.edu
Contact: Elena Young, MS,CCRP 602-827-9963 elenay@email.arizona.edu

Locations
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United States, Arizona
Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Regina Montero, MSN    480-239-8697    rmontero@email.arizona.edu   
Contact: Elena Young, MS, CCRP    602-827-9963    elenay@email.arizona.edu   
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Rachael Smith, DO UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix

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Responsible Party: Rachael Bailey Smith, Dr. Rachael Smith, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT03646136     History of Changes
Other Study ID Numbers: UA IRB# 1808885089
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases