Trial Outcomes & Findings for Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection (NCT NCT03208192)
NCT ID: NCT03208192
Last Updated: 2020-09-24
Results Overview
Absolute blood loss (ml) will be calculated as the amount of blood (collected only during the parenchyma resection) in suction the container after the subtraction of all irrigating fluids and weighing operative sponges.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
1 day
Results posted on
2020-09-24
Participant Flow
Partipants were recruited at Moscow Clinical Scientific Center. The first participant was enrolled on Feb 2017 and the last participant was enrolled in April 2020
Of 68 enrolled participants, met inlusion criteria and were randomized.
Participant milestones
| Measure |
ErbeJet
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
36
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 14 • n=32 Participants
|
54 years
STANDARD_DEVIATION 15 • n=36 Participants
|
55 years
STANDARD_DEVIATION 14 • n=68 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=32 Participants
|
21 Participants
n=36 Participants
|
41 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=32 Participants
|
15 Participants
n=36 Participants
|
27 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index (BMI)
|
28.4 kg/m^2
STANDARD_DEVIATION 6.9 • n=32 Participants
|
30 kg/m^2
STANDARD_DEVIATION 5.2 • n=36 Participants
|
29 kg/m^2
STANDARD_DEVIATION 6.1 • n=68 Participants
|
|
Physical status classification system (ASA)
ASA 1
|
3 Participants
n=32 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=68 Participants
|
|
Physical status classification system (ASA)
ASA 2
|
15 Participants
n=32 Participants
|
20 Participants
n=36 Participants
|
35 Participants
n=68 Participants
|
|
Physical status classification system (ASA)
ASA 3
|
14 Participants
n=32 Participants
|
12 Participants
n=36 Participants
|
26 Participants
n=68 Participants
|
|
Malignant/benign lesions
Malignant
|
18 Participants
n=32 Participants
|
24 Participants
n=36 Participants
|
42 Participants
n=68 Participants
|
|
Malignant/benign lesions
Bening
|
14 Participants
n=32 Participants
|
12 Participants
n=36 Participants
|
26 Participants
n=68 Participants
|
|
Tumor size (mm)
|
71 mm
n=32 Participants
|
51 mm
n=36 Participants
|
61 mm
n=68 Participants
|
|
Postero-superior segments
|
16 Participants
n=32 Participants
|
20 Participants
n=36 Participants
|
36 Participants
n=68 Participants
|
|
Difficulty index score (IWATE Criteria) Low\Intermediate\Advanced\Expert
|
7 units on a scale
n=32 Participants
|
7 units on a scale
n=36 Participants
|
7 units on a scale
n=68 Participants
|
PRIMARY outcome
Timeframe: 1 dayAbsolute blood loss (ml) will be calculated as the amount of blood (collected only during the parenchyma resection) in suction the container after the subtraction of all irrigating fluids and weighing operative sponges.
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Intraoperative Blood Loss
|
195 ml
Interval 10.0 to 400.0
|
218 ml
Interval 10.0 to 1400.0
|
SECONDARY outcome
Timeframe: 1 dayАbsolute measurement of blood loss in relation to resection size (ml/cm\^2).
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)
|
3.9 ml/cm^2
Interval 0.9 to 10.6
|
5 ml/cm^2
Interval 0.4 to 20.0
|
SECONDARY outcome
Timeframe: 1 dayDuration of liver parenchyma transaction (min)
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Duration of Liver Parenchyma Transaction
|
107 min
Interval 19.0 to 305.0
|
100 min
Interval 20.0 to 300.0
|
SECONDARY outcome
Timeframe: 1 daythe number of participants who needed to apply the Pringle maneuver
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Necessity to Apply the Pringle Maneuver.
|
15 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 1 dayThe total duration of Pringle maneuver (min)
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
The Total Duration of Pringle Maneuver.
|
23 min
Interval 3.0 to 59.0
|
18 min
Interval 2.0 to 48.0
|
SECONDARY outcome
Timeframe: up to 1 monthHospital stay (day)
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Hospital Stay (Day)
|
8 day
Interval 5.0 to 16.0
|
8 day
Interval 4.0 to 19.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysMorbidity according to Clavien-Dindo classification (it is advisable to activate complications class II-V). The Clavien-Dindo classification (CDC) is a standardized system for the registration of surgical complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The major characteristic of the CDC system is that the severity of a complication is graded based on the type of therapy required to treat the complication. The CDC system has been validated and accepted worldwide for use in many fields of surgery. The complications that change the treatment of grade II-V.
Outcome measures
| Measure |
ErbeJet
n=32 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
|
Misonix
n=36 Participants
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
|
|---|---|---|
|
Morbidity
|
2 Participants
|
2 Participants
|
Adverse Events
ErbeJet
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Misonix
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ErbeJet
n=32 participants at risk
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
|
Misonix
n=36 participants at risk
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
|
|---|---|---|
|
Hepatobiliary disorders
fluid accumulation
|
6.2%
2/32 • Number of events 2 • 30 days after the operation
The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions
|
5.6%
2/36 • Number of events 2 • 30 days after the operation
The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions
|
Other adverse events
| Measure |
ErbeJet
n=32 participants at risk
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
|
Misonix
n=36 participants at risk
liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
|
|---|---|---|
|
Surgical and medical procedures
fluid collection
|
6.2%
2/32 • Number of events 2 • 30 days after the operation
The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions
|
5.6%
2/36 • Number of events 2 • 30 days after the operation
The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions
|
Additional Information
Mikhail Efanov, MD, PhD,
Moscow Clinical Scientific Center
Phone: +79161058830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place