Trial Outcomes & Findings for Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy (NCT NCT04556396)
NCT ID: NCT04556396
Last Updated: 2024-06-06
Results Overview
The percentage of patients requiring subsequent surgical intervention to remove residual stones
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
234 participants
Primary outcome timeframe
90 days
Results posted on
2024-06-06
Participant Flow
Participant milestones
| Measure |
Intervention Arm
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
174
|
|
Overall Study
COMPLETED
|
60
|
174
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=60 Participants
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
n=174 Participants
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 15 • n=99 Participants
|
57 years
STANDARD_DEVIATION 15 • n=107 Participants
|
57.9 years
STANDARD_DEVIATION 15.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
46 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
6 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
54 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
174 participants
n=107 Participants
|
234 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysThe percentage of patients requiring subsequent surgical intervention to remove residual stones
Outcome measures
| Measure |
Intervention Arm
n=60 Participants
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
n=174 Participants
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
|---|---|---|
|
"Second Look" Rate
Reintervention
|
4 Participants
|
56 Participants
|
|
"Second Look" Rate
No Reintervention
|
56 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe average length of inpatient hospital stay in days
Outcome measures
| Measure |
Intervention Arm
n=60 Participants
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
n=174 Participants
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
|---|---|---|
|
Hospital Length of Stay
|
2.3 Days
Standard Deviation 1.5
|
3.5 Days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 90 daysThe percentage of patients experiencing Clavien-Dindo Grade III-V complications (major) related to the patients' surgery.
Outcome measures
| Measure |
Intervention Arm
n=60 Participants
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
n=174 Participants
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
|---|---|---|
|
Surgical Complication Rate
|
2 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe percentage of patients who are rendered without residual kidney stone burden after their surgery based on CT scan
Outcome measures
| Measure |
Intervention Arm
n=60 Participants
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
n=174 Participants
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
|---|---|---|
|
"Stone Free" Rate
|
49 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 90 daysThe percentage of patients who presented with symptoms of renal obstruction following their surgery
Outcome measures
| Measure |
Intervention Arm
n=60 Participants
This arm will receive cone beam CT to perform an abdomen-pelvis CT scan immediately following initial percutaneous nephrolithotomy, before the patient emerges from general anesthesia, to allow the surgeon to determine whether additional work is needed or whether the procedure can be concluded without requiring further imaging or future interventions.
Cone beam CT: On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
|
Retrospective Arm
n=174 Participants
This arm will contain a retrospective cohort of patients who underwent surgery prior to the enrollment of the intervention arm. These patients received the standard of care, namely helical CT postoperative day one.
|
|---|---|---|
|
Reobstruction Rate
|
11 Participants
|
26 Participants
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Retrospective Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place