Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

Study Overview
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Brief Summary
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Objective: The investigators seek to compare the efficiency of the cystoscopy with two interventions: patient position during the cystoscopy (Trendelenburg (head down) or flat) Abdominal insufflation (insufflation versus no insufflation)

Detailed Description
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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: patient position during the cystoscopy (Trendelenburg (head down) or flat) 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.

Official Title
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Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial

Conditions
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Bladder Integrity, Bladder Function, Ureteral Integrity, Ureteral Function

Intervention / Treatment
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* Other: Flat position
* Other: Trendelenburg position
* Device: Insufflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flat position with no Insufflation<br> | Other: Flat position<br>* Flat patient position during the cystoscopy<br>|
| Experimental: Trendelenburg position and Insufflation<br>insufflation to 15 mm Hg | Other: Trendelenburg position<br>* Trendelenburg position (head down) during the cystoscopy<br>Device: Insufflation<br>* Insufflation to 15 mm Hg<br>|
| Experimental: Flat position and Insufflation<br> | Other: Flat position<br>* Flat patient position during the cystoscopy<br>Device: Insufflation<br>* Insufflation to 15 mm Hg<br>|
| Experimental: Trendelenburg position with no Insufflation<br> | Other: Trendelenburg position<br>* Trendelenburg position (head down) during the cystoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in seconds to complete the cystourethroscopy | Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra). | From the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes) |