Trial Outcomes & Findings for Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy (NCT NCT05786391)
NCT ID: NCT05786391
Last Updated: 2025-02-24
Results Overview
Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)
Results posted on
2025-02-24
Participant Flow
Participant milestones
| Measure |
Flat Position With no Insufflation
Flat position: Flat patient position during the cystoscopy
|
Trendelenburg Position and Insufflation
insufflation to 15 mm Hg
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Flat Position and Insufflation
Flat position: Flat patient position during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Trendelenburg Position With no Insufflation
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
31
|
30
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
Baseline characteristics by cohort
| Measure |
Flat Position With no Insufflation
n=31 Participants
Flat position: Flat patient position during the cystoscopy
|
Trendelenburg Position and Insufflation
n=30 Participants
insufflation to 15 mm Hg
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Flat Position and Insufflation
n=30 Participants
Flat position: Flat patient position during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Trendelenburg Position With no Insufflation
n=31 Participants
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45 years
n=31 Participants
|
44 years
n=30 Participants
|
46 years
n=30 Participants
|
45 years
n=31 Participants
|
45 years
n=122 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
122 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
6 Participants
n=31 Participants
|
28 Participants
n=122 Participants
|
|
Race/Ethnicity, Customized
Other (non-Caucasian)
|
22 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
23 Participants
n=30 Participants
|
25 Participants
n=31 Participants
|
94 Participants
n=122 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
31 participants
n=31 Participants
|
122 participants
n=122 Participants
|
|
Number of participants with Diabetes
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=31 Participants
|
13 Participants
n=122 Participants
|
|
Number of participants with hypertension
|
9 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
10 Participants
n=31 Participants
|
29 Participants
n=122 Participants
|
|
Number of participants who smoke
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=122 Participants
|
|
Number of participants with hyperlipidemia
|
1 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=31 Participants
|
13 Participants
n=122 Participants
|
|
Number of participants with heart disease
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=122 Participants
|
|
Number of participants with lung disease
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=122 Participants
|
|
Number of Participants with history of previous abdominal surgery
|
17 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
20 Participants
n=30 Participants
|
21 Participants
n=31 Participants
|
84 Participants
n=122 Participants
|
|
Parity
0
|
26 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
22 Participants
n=31 Participants
|
101 Participants
n=122 Participants
|
|
Parity
1 or more
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=31 Participants
|
21 Participants
n=122 Participants
|
|
Level of Creatinine
|
0.78 milligrams per deciliter
n=31 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
0.78 milligrams per deciliter
n=29 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
0.71 milligrams per deciliter
n=30 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
0.82 milligrams per deciliter
n=31 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
0.78 milligrams per deciliter
n=121 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
|
Hemoglobin level at admission
|
12.40 grams per deciliter
n=31 Participants
|
12.05 grams per deciliter
n=30 Participants
|
11.45 grams per deciliter
n=30 Participants
|
12.00 grams per deciliter
n=31 Participants
|
12.00 grams per deciliter
n=122 Participants
|
|
Hemoglobin A1c (HbA1c) at Pre-operation
|
5.35 percentage of HbA1c
n=6 Participants • Data were not collected for 25 participants in the Flat position with no Insufflation arm. Data were not collected for 25 participants in the Trendelenburg position and Insufflation arm. Data were not collected for 25 participants in the Flat position and Insufflation arm. Data were not collected for 23 participants in the Trendelenburg position with no Insufflation arm.
|
5.80 percentage of HbA1c
n=5 Participants • Data were not collected for 25 participants in the Flat position with no Insufflation arm. Data were not collected for 25 participants in the Trendelenburg position and Insufflation arm. Data were not collected for 25 participants in the Flat position and Insufflation arm. Data were not collected for 23 participants in the Trendelenburg position with no Insufflation arm.
|
5.50 percentage of HbA1c
n=5 Participants • Data were not collected for 25 participants in the Flat position with no Insufflation arm. Data were not collected for 25 participants in the Trendelenburg position and Insufflation arm. Data were not collected for 25 participants in the Flat position and Insufflation arm. Data were not collected for 23 participants in the Trendelenburg position with no Insufflation arm.
|
6.00 percentage of HbA1c
n=8 Participants • Data were not collected for 25 participants in the Flat position with no Insufflation arm. Data were not collected for 25 participants in the Trendelenburg position and Insufflation arm. Data were not collected for 25 participants in the Flat position and Insufflation arm. Data were not collected for 23 participants in the Trendelenburg position with no Insufflation arm.
|
5.60 percentage of HbA1c
n=24 Participants • Data were not collected for 25 participants in the Flat position with no Insufflation arm. Data were not collected for 25 participants in the Trendelenburg position and Insufflation arm. Data were not collected for 25 participants in the Flat position and Insufflation arm. Data were not collected for 23 participants in the Trendelenburg position with no Insufflation arm.
|
|
Glomerular Filtration Rate (GFR) at admission
|
96 milliliters per minutes
n=31 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
94 milliliters per minutes
n=29 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
106 milliliters per minutes
n=30 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
88 milliliters per minutes
n=31 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
96 milliliters per minutes
n=121 Participants • Data were not collected for 1 participant in the Trendelenburg position and Insufflation arm.
|
|
Body Mass Index
|
30 kg/m^2
n=31 Participants
|
31 kg/m^2
n=30 Participants
|
31 kg/m^2
n=30 Participants
|
35 kg/m^2
n=31 Participants
|
31 kg/m^2
n=122 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Flat Position With no Insufflation
n=31 Participants
Flat position: Flat patient position during the cystoscopy
|
Trendelenburg Position and Insufflation
n=30 Participants
insufflation to 15 mm Hg
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Flat Position and Insufflation
n=30 Participants
Flat position: Flat patient position during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Trendelenburg Position With no Insufflation
n=31 Participants
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
|
|---|---|---|---|---|
|
Time in Seconds to Complete the Cystourethroscopy
|
103 seconds
Interval 65.0 to 184.0
|
117 seconds
Interval 50.0 to 223.0
|
147 seconds
Interval 71.0 to 208.0
|
82 seconds
Interval 71.0 to 136.0
|
Adverse Events
Flat Position With no Insufflation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Trendelenburg Position and Insufflation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Flat Position and Insufflation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Trendelenburg Position With no Insufflation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flat Position With no Insufflation
n=31 participants at risk
Flat position: Flat patient position during the cystoscopy
|
Trendelenburg Position and Insufflation
n=30 participants at risk
insufflation to 15 mm Hg
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Flat Position and Insufflation
n=30 participants at risk
Flat position: Flat patient position during the cystoscopy
Insufflation: Insufflation to 15 mm Hg
|
Trendelenburg Position With no Insufflation
n=31 participants at risk
Trendelenburg position: Trendelenburg position (head down) during the cystoscopy
|
|---|---|---|---|---|
|
General disorders
Dizziness
|
0.00%
0/31 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
3.3%
1/30 • 6 weeks
|
0.00%
0/31 • 6 weeks
|
|
General disorders
Fall
|
0.00%
0/31 • 6 weeks
|
3.3%
1/30 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
0.00%
0/31 • 6 weeks
|
|
General disorders
Post-Operation abdominal pain
|
0.00%
0/31 • 6 weeks
|
3.3%
1/30 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
0.00%
0/31 • 6 weeks
|
|
General disorders
Vaginal Bleeding
|
3.2%
1/31 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
0.00%
0/30 • 6 weeks
|
0.00%
0/31 • 6 weeks
|
Additional Information
Randa J Jalloul, MD
The University of Texas Health Science Center at Houston
Phone: 713-566-5749
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place