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Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

Not Applicable
Completed
Conditions
Ureteral Integrity
Bladder Integrity
Bladder Function
Ureteral Function
Interventions
Other: Flat position
Other: Trendelenburg position
Device: Insufflation
Registration Number
NCT05786391
Lead Sponsor
The University of Texas Health Science Center, Houston
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Flat position with no InsufflationFlat position-
Trendelenburg position and InsufflationTrendelenburg positioninsufflation to 15 mm Hg
Trendelenburg position with no InsufflationTrendelenburg position-
Flat position and InsufflationInsufflation-
Flat position and InsufflationFlat position-
Trendelenburg position and InsufflationInsufflationinsufflation to 15 mm Hg
Primary Outcome Measures
NameTimeMethod
Time in Seconds to Complete the CystourethroscopyFrom 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
NameTimeMethod

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

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