Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy
- Conditions
- Ureteral IntegrityBladder IntegrityBladder FunctionUreteral Function
- Interventions
- Other: Flat positionOther: Trendelenburg positionDevice: Insufflation
- Registration Number
- NCT05786391
- Brief Summary
Objective:
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
1. patient position during the cystoscopy (Trendelenburg (head down) or flat)
2. Abdominal insufflation (insufflation versus no insufflation)
- Detailed Description
This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.
The investigators seek to compare the efficiency of the cystoscopy with two interventions:
1. patient position during the cystoscopy (Trendelenburg (head down) or flat)
2. Abdominal insufflation (insufflation versus no insufflation).
Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).
- Pregnancy
- Known urologic anomaly
- Unplanned cystoscopy
- Cancer surgery
- Urogynecology surgery
- comorbidities including cardiac disease, chronic hypertension, any stage kidney disease (including abnormal creatinine level), and use of diuretics.
- Undergoing extensive ureterolysis
- Blood loss more than 500 milliliters (mLs)
- Contra-indications to position change and insufflation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flat position with no Insufflation Flat position - Trendelenburg position and Insufflation Trendelenburg position insufflation to 15 mm Hg Trendelenburg position with no Insufflation Trendelenburg position - Flat position and Insufflation Insufflation - Flat position and Insufflation Flat position - Trendelenburg position and Insufflation Insufflation insufflation to 15 mm Hg
- Primary Outcome Measures
Name Time Method Time in Seconds to Complete the Cystourethroscopy From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes) Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States