Trials / Completed
CompletedNCT05786391
Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy
Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- Female
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Flat position | Flat patient position during the cystoscopy |
| OTHER | Trendelenburg position | Trendelenburg position (head down) during the cystoscopy |
| DEVICE | Insufflation | Insufflation to 15 mm Hg |
Timeline
- Start date
- 2023-04-11
- Primary completion
- 2024-02-05
- Completion
- 2024-02-05
- First posted
- 2023-03-27
- Last updated
- 2025-02-24
- Results posted
- 2025-02-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05786391. Inclusion in this directory is not an endorsement.