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Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Flat position with no Insufflation
  • Other: Flat position
    Flat patient position during the cystoscopy
Experimental
Trendelenburg position and Insufflation 		insufflation to 15 mm Hg
  • Other: Trendelenburg position
    Trendelenburg position (head down) during the cystoscopy
  • Device: Insufflation
    Insufflation to 15 mm Hg
Experimental
Flat position and Insufflation
  • Other: Flat position
    Flat patient position during the cystoscopy
  • Device: Insufflation
    Insufflation to 15 mm Hg
Experimental
Trendelenburg position with no Insufflation
  • Other: Trendelenburg position
    Trendelenburg position (head down) during the cystoscopy

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Sunbola Ashimi, PhD
713-500-6410
sunbola.s.ashimi@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Sunbola Ashimi, PhD
713-500-6410
sunbola.s.ashimi@uth.tmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.