Trial Outcomes & Findings for Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy (NCT NCT02805517)
NCT ID: NCT02805517
Last Updated: 2022-12-13
Results Overview
Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
up to 1 day postoperatively
Results posted on
2022-12-13
Participant Flow
Participant milestones
| Measure |
PEAL Laparoscopic Nephrectomy
Patients who underwent Percutaneous Externally-Assembled Laparoscopic (PEAL) donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
Baseline characteristics by cohort
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
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6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 day postoperativelyPopulation: All patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy
Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type.
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
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5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
|
Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Time to First Opioid Use
|
74.5 minutes
Interval 28.0 to 677.0
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—
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—
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—
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PRIMARY outcome
Timeframe: 3 days postoperativelyPopulation: Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy
Total opioid dosage administered throughout the patient's inpatient stay. Measured in units of Morphine Milligram Equivalents (MME).
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
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5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
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Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Total Inpatient Opioid Dosage
|
31.3 Morphine Milligram Equivalents (MME)
Standard Deviation 9.3
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—
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—
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—
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PRIMARY outcome
Timeframe: up to 2 days postoperativelyPopulation: Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy
A patient-reported pain score (on a scale of 1-10, with 10 being the worst) for each of the four port-site incisions, as measured by the Brief Pain Inventory. Scores were measured on both post-operative day one and on post-operative day two. The four port-site incisions which patients ranked pain scores for were: #1 - Hand-assist Port; #2 - 12 mm Port; #3 - 5 mm Port; #4 - Percutaneous Externally-Assembled Laparoscopic (PEAL) Port. A mean pain score was calculated by averaging the data across the two days.
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=3 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
n=3 Participants
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
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5 mm Trochar Port-site Location
n=3 Participants
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
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Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
n=3 Participants
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Pain Score of All Surgical Sites
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5.6 score on a scale
Standard Deviation 2.1
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5.4 score on a scale
Standard Deviation 1.9
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5.2 score on a scale
Standard Deviation 2.6
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2.2 score on a scale
Standard Deviation 1.7
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SECONDARY outcome
Timeframe: up to 3 days post-operativelyPopulation: Patients who underwent donor nephrectomy
Duration of post-operative ileus as measured by days until return of normal bowel function was noted.
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
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5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
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Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Post-operative Ileus
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2 days
Interval 1.0 to 3.0
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—
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—
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—
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SECONDARY outcome
Timeframe: 3 days post-operativelyPopulation: Patients who underwent donor nephrectomy
Number of post-operative days before patient was noted to be ambulating.
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
|
5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
|
Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Time to Ambulation
|
1.5 days
Interval 1.0 to 3.0
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—
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—
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—
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SECONDARY outcome
Timeframe: up do 4 days post-operativelyPopulation: Patients who underwent donor nephrectomy
Number of days admitted to the hospital from surgery until hospital discharge
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
|
5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
|
Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Length of Hospital Stay
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2.23 days
Standard Deviation 0.59
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—
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—
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—
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SECONDARY outcome
Timeframe: IntraoperativelyPopulation: Patients who underwent donor nephrectomy
The number of patients with an intraoperative complication.
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
|
5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
|
Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Presence of Intraoperative Complications
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0 Participants
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—
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—
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—
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SECONDARY outcome
Timeframe: Intraoperatively (up to 6 hours)Population: Patients who underwent donor nephrectomy
Duration of surgical operation from incision time to procedure stop time
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
|
5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
|
Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Length of Operative Time
|
3.4 hours
Standard Deviation 0.3
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—
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—
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—
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SECONDARY outcome
Timeframe: Intraoperatively (up to 6 hours)Population: Patients who underwent donor nephrectomy
Estimated Blood Loss during the nephrectomy procedure
Outcome measures
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 Participants
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
|
12 mm Trochar Port-site Location
Patient reported scores of the 12mm port-site pain level. Mean of both post-operative days one and two. All patients had one 12mm port.
|
5 mm Trochar Port-site Location
Patient reported scores of the 5 mm port-site pain level. Mean of both post-operative days one and two. All patients had one 5 mm port.
|
Percutaneous Externally Assembled Laparoscopic (3 mm) Port-site Location
Patient reported scores of the Percutaneous Externally Assembled Laparoscopic (3 mm) port-site pain level. Mean of both post-operative days one and two. All patients had one Percutaneous Externally Assembled Laparoscopic (3 mm) port.
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|---|---|---|---|---|
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Estimated Intraoperative Blood Loss
|
33.3 mL
Standard Deviation 11.8
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—
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—
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—
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Adverse Events
PEAL Laparoscopic Nephrectomy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PEAL Laparoscopic Nephrectomy
n=6 participants at risk
Patients who underwent percutaneous externally-assembled laparoscopic donor nephrectomy using 3 mm instruments.
Percuvance™ Percutaneous Surgical System: Patients underwent percutaneous externally-assembled laparoscopic donor nephrectomy where one or more 3 mm instruments were used in addition to conventional 5 or 12 mm trocars and the standard hand-assist port.
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|---|---|
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Gastrointestinal disorders
Post-operative nausea
|
16.7%
1/6 • Number of events 1 • Up to patients' second clinical follow-up visit, occurring at approximately the six month mark.
Not different from clinicaltrials.gov definitions
|
|
Nervous system disorders
Post-operative dizziness
|
16.7%
1/6 • Number of events 1 • Up to patients' second clinical follow-up visit, occurring at approximately the six month mark.
Not different from clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place