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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Retention||Procedure: Retained fluid Procedure: Emptied fluid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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.|
|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|
Experimental: Retained Cystoscopy Fluid
Retained 200mL normal saline used for distending media following completion of diagnostic cystoscopy
Procedure: Retained fluid
Active Comparator: Cystoscopy Fluid Emptied
Emptied 200mL normal saline used for distending media following completion of diagnostic cystoscopy
Procedure: Emptied fluid
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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).
- 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).
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
|Contact: Regina Montero, MSNfirstname.lastname@example.org|
|Contact: Elena Young, MS,CCRPemail@example.com|
|United States, Arizona|
|Banner University Medical Center Phoenix||Recruiting|
|Phoenix, Arizona, United States, 85006|
|Contact: Regina Montero, MSN 480-239-8697 firstname.lastname@example.org|
|Contact: Elena Young, MS, CCRP 602-827-9963 email@example.com|
|Principal Investigator:||Rachael Smith, DO||UofA College of Medicine Dept of OBG/Banner University Medical Center Phoenix|