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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
Sponsor:
Information provided by (Responsible Party):
Jonathon Solnik, Women's College Hospital

Tracking Information
First Submitted Date  ICMJE December 12, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date December 13, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
Time to first void [ Time Frame: 3 hours ]
Time in minutes from arrival in post-operative anesthesia unit (PACU) to first void
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Operative Voiding After Gynecological Surgery Trial
Official Title  ICMJE Post-Operative Voiding After Gynecological Surgery (POVAGS) Trial: a Randomized Controlled Trial on Retrograde Bladder Filling After Outpatient Gynaecological Laparoscopy
Brief Summary To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Urinary Retention
  • Postoperative Complications
  • Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Retrograde filled
    This arm will contain patients who had retrograde bladder filling upon completion of surgery with 200 milliliters (mL) of sterile saline.
    Intervention: Procedure: Retrograde bladder filling
  • 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.
Publications * Moawad G, Tyan P, Marfori C, Abi Khalil E, Park D. Effect of postoperative partial bladder filling after minimally invasive hysterectomy on postanesthesia care unit discharge and cost: a single-blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Apr;220(4):367.e1-367.e7. doi: 10.1016/j.ajog.2018.12.034. Epub 2019 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women
  • Undergoing elective laparoscopy for a gynaecological indication
  • Plan for same day discharge
  • Able to provide informed consent

Exclusion Criteria:

  • Pregnancy
  • Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
  • Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
  • Pre-existing voiding dysfunction
  • Known recurrent urinary tract infections
  • Known genito-urinary malformations
  • Known for neuromuscular disorders such as multiple sclerosis
  • Use of anticholinergic medication
  • Intraoperative bladder related complications
  • Need for discharge with indwelling foley catheter
  • Patients requiring overnight admission for any reason
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: patients undergoing gynecological surgery
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Andrew Zakhari, MD 5147937921 andrew.zakhari@mail.mcgill.ca
Contact: Ally Murji, MD 4165651050 ally.murji@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04198285
Other Study ID Numbers  ICMJE 2019-0110-E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathon Solnik, Women's College Hospital
Study Sponsor  ICMJE Women's College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ally Murji, MD Women's College Hospital
PRS Account Women's College Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP