Bladder Integrity, Bladder Function, Ureteral Integrity, Ureteral Function
Conditions
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.
Interventions
OTHERFlat position
Flat patient position during the cystoscopy
Trendelenburg position (head down) during the cystoscopy
DEVICEInsufflation
Insufflation to 15 mm Hg
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flat Position With no Insufflation Flat position: Flat patient position during the cystoscopy | 31 |
| Trendelenburg Position and Insufflation insufflation to 15 mm Hg
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
Insufflation: Insufflation to 15 mm Hg | 30 |
| Flat Position and Insufflation Flat position: Flat patient position during the cystoscopy
Insufflation: Insufflation to 15 mm Hg | 30 |
| Trendelenburg Position With no Insufflation Trendelenburg position: Trendelenburg position (head down) during the cystoscopy | 31 |
| Total | 122 |
Baseline characteristics
| Characteristic | Trendelenburg Position and Insufflation | Flat Position and Insufflation | Flat Position With no Insufflation | Trendelenburg Position With no Insufflation | Total |
|---|---|---|---|---|---|
| Age, Continuous | 44 years | 46 years | 45 years | 45 years | 45 years |
| Body Mass Index | 31 kg/m^2 | 31 kg/m^2 | 30 kg/m^2 | 35 kg/m^2 | 31 kg/m^2 |
| Glomerular Filtration Rate (GFR) at admission | 94 milliliters per minutes | 106 milliliters per minutes | 96 milliliters per minutes | 88 milliliters per minutes | 96 milliliters per minutes |
| Hemoglobin A1c (HbA1c) at Pre-operation | 5.80 percentage of HbA1c | 5.50 percentage of HbA1c | 5.35 percentage of HbA1c | 6.00 percentage of HbA1c | 5.60 percentage of HbA1c |
| Hemoglobin level at admission | 12.05 grams per deciliter | 11.45 grams per deciliter | 12.40 grams per deciliter | 12.00 grams per deciliter | 12.00 grams per deciliter |
| Level of Creatinine | 0.78 milligrams per deciliter | 0.71 milligrams per deciliter | 0.78 milligrams per deciliter | 0.82 milligrams per deciliter | 0.78 milligrams per deciliter |
| Number of participants who smoke | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of participants with Diabetes | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 13 Participants |
| Number of participants with heart disease | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Number of Participants with history of previous abdominal surgery | 26 Participants | 20 Participants | 17 Participants | 21 Participants | 84 Participants |
| Number of participants with hyperlipidemia | 6 Participants | 2 Participants | 1 Participants | 4 Participants | 13 Participants |
| Number of participants with hypertension | 9 Participants | 1 Participants | 9 Participants | 10 Participants | 29 Participants |
| Number of participants with lung disease | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 6 Participants |
| Parity 0 | 26 Participants | 27 Participants | 26 Participants | 22 Participants | 101 Participants |
| Parity 1 or more | 4 Participants | 3 Participants | 5 Participants | 9 Participants | 21 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 7 Participants | 9 Participants | 6 Participants | 28 Participants |
| Race/Ethnicity, Customized Other (non-Caucasian) | 24 Participants | 23 Participants | 22 Participants | 25 Participants | 94 Participants |
| Region of Enrollment United States | 30 participants | 30 participants | 31 participants | 31 participants | 122 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 31 Participants | 31 Participants | 122 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 1 / 31 | 2 / 30 | 1 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 | 0 / 30 | 0 / 31 |
Outcome results
Primary
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).
Time frame: From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Flat Position With no Insufflation | Time in Seconds to Complete the Cystourethroscopy | 103 seconds |
| Trendelenburg Position and Insufflation | Time in Seconds to Complete the Cystourethroscopy | 117 seconds |
| Flat Position and Insufflation | Time in Seconds to Complete the Cystourethroscopy | 147 seconds |
| Trendelenburg Position With no Insufflation | Time in Seconds to Complete the Cystourethroscopy | 82 seconds |