Trial Outcomes & Findings for "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy (NCT NCT01261819)
NCT ID: NCT01261819
Last Updated: 2020-10-08
Results Overview
Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
During Procedure (Up to 15 minutes)
Results posted on
2020-10-08
Participant Flow
Participant milestones
| Measure |
Transurethral Laparoscope
These patients had cystoscopy performed with the transurethral laparoscope.
|
Traditional Cystoscopy
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"Laparoscopic" Cystoscopy Versus Traditional Cystoscopy
Baseline characteristics by cohort
| Measure |
Transurethral Laparoscope
n=33 Participants
These patients had cystoscopy performed with the transurethral laparoscope.
cystoscopy
|
Traditional Cystoscopy
n=33 Participants
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
cystoscopy
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 6.33 • n=93 Participants
|
44.5 years
STANDARD_DEVIATION 5.10 • n=4 Participants
|
45 years
STANDARD_DEVIATION 5.72 • n=27 Participants
|
|
Sex/Gender, Customized
Female
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
BMI
|
28.6 kg/m^2
STANDARD_DEVIATION 6.65 • n=93 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 5.14 • n=4 Participants
|
27.85 kg/m^2
STANDARD_DEVIATION 5.90 • n=27 Participants
|
|
Smoker (%)
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: During Procedure (Up to 15 minutes)Time required to perform cystoscopy with a laparoscope or a cystoscope after laparoscopic hysterectomy.
Outcome measures
| Measure |
Transurethral Laparoscope
n=33 Participants
These patients had cystoscopy performed with the transurethral laparoscope.
|
Traditional Cystoscopy
n=33 Participants
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
|
|---|---|---|
|
Time Required to Perform Procedure (in Seconds)
|
137 seconds
Interval 21.1 to 249.9
|
451 seconds
Interval 204.63 to 697.37
|
Adverse Events
Transurethral Laparoscope
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Traditional Cystoscopy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transurethral Laparoscope
n=33 participants at risk
These patients had cystoscopy performed with the transurethral laparoscope.
|
Traditional Cystoscopy
n=33 participants at risk
These patients had cystoscopy performed with the traditional cystoscope, which is considered to be the "gold standard."
|
|---|---|---|
|
Renal and urinary disorders
bladder discomfort/pain
|
0.00%
0/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
6.1%
2/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
|
Renal and urinary disorders
hematoma
|
0.00%
0/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
3.0%
1/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
|
Renal and urinary disorders
Postoperative Urinary Tract Infection (UTI)
|
0.00%
0/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
6.1%
2/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
|
Reproductive system and breast disorders
Vaginal bleed
|
0.00%
0/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
3.0%
1/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
|
Surgical and medical procedures
Trocar-site bleed
|
3.0%
1/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
0.00%
0/33 • Adverse event data was collected for the duration of the study January-July 2009, and up to 6 weeks after the surgical intervention for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place