Post-Operative Voiding After Gynecological Surgery Trial (POVAGS)
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|ClinicalTrials.gov Identifier: NCT04198285|
Recruitment Status : Not yet recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Retention Postoperative Complications Surgery||Procedure: Retrograde bladder filling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: Retrograde filled
This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.
Procedure: Retrograde bladder filling
The bladder will be filled with a large syringe through the urinary catheter (which is left in place for the surgery) with 200mL of sterile saline, and then the catheter will be removed.
No Intervention: Control
This arm will contain patients who simply had the urinary catheter removed upon completion of surgery, and were left with an empty bladder.
- Time to first void [ Time Frame: 3 hours ]Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
- Time to discharge [ Time Frame: 8 hours ]Time in minutes from arrival in PACU to discharge from PACU
- Post-operative complications [ Time Frame: 1 week following surgery ]Urinary tract infections, or other reported complications
- Patient satisfaction [ Time Frame: 1 week ]Patients' subjective experience in both groups regarding time spent in PACU and first postoperative week
- Post-operative pain [ Time Frame: Assessed at the 1 hour mark ]visual analogue scale of postoperative pain, assessed in PACU
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): NCT04198285
|Contact: Andrew Zakhari, MDemail@example.com|
|Contact: Ally Murji, MDfirstname.lastname@example.org|
|Principal Investigator:||Ally Murji, MD||Women's College Hospital|