Trial Outcomes & Findings for Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy (NCT NCT03192904)
NCT ID: NCT03192904
Last Updated: 2021-08-31
Results Overview
The primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow \>50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
postoperative in-hospital stay up to 30 days
Results posted on
2021-08-31
Participant Flow
Participant milestones
| Measure |
Energy Instruments Group
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Energy Instruments Group
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy
Baseline characteristics by cohort
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Segments resected
LS3c
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
LS1+2+LS3c
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 10.4 • n=99 Participants
|
53.3 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
52.7 years
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
32 participants
n=99 Participants
|
33 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Smoking History
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Comorbidity
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
ASA Grade
I
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
ASA Grade
II
|
31 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
ASA Grade
III
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Segments resected
RS1
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Segments resected
RS2
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Segments resected
RS3
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Segments resected
RS6
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Segments resected
RS8
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
RS1+RS2
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
RS9+RS10
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
RS1a+RS2
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Segments resected
RS1b+RS3
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
RS1b+RS3b
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
RS2b+RS3a
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
RS8b+RS9
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
LS1+2
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Segments resected
LS3
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Segments resected
LS6
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Segments resected
LS9
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
LS10
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
LS1+2+LS3
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Segments resected
LS4+LS5
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Segments resected
LS6+LS8
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Segments resected
LS7+LS8+LS9+LS10
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Approaches(Video-Assisted Thoracic Surgery or Robotic)
Video-Assisted Thoracic Surgery
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Approaches(Video-Assisted Thoracic Surgery or Robotic)
Robotic
|
27 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Height
|
162.9 cm
STANDARD_DEVIATION 6.7 • n=99 Participants
|
164.5 cm
STANDARD_DEVIATION 7.7 • n=107 Participants
|
163.7 cm
STANDARD_DEVIATION 7.2 • n=206 Participants
|
|
Weight
|
60.0 kg
STANDARD_DEVIATION 8.1 • n=99 Participants
|
63.4 kg
STANDARD_DEVIATION 8.7 • n=107 Participants
|
61.7 kg
STANDARD_DEVIATION 8.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: postoperative in-hospital stay up to 30 daysThe primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow \>50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan).
Outcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Incidence of Postoperative Complications
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: postoperative in-hospital stay up to 30 daysOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Incidence Rates of Each Postoperative Complications
Air leakage
|
7 Participants
|
1 Participants
|
|
Incidence Rates of Each Postoperative Complications
Pneumothorax
|
3 Participants
|
0 Participants
|
|
Incidence Rates of Each Postoperative Complications
Septic shock
|
0 Participants
|
1 Participants
|
|
Incidence Rates of Each Postoperative Complications
Cardiac arrest
|
1 Participants
|
0 Participants
|
|
Incidence Rates of Each Postoperative Complications
No complications
|
21 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Baseline.Outcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Preoperative Lung Function
|
2.73 L
Standard Deviation 0.50
|
2.80 L
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: at the 3rd month after surgeryOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Postoperative Lung Function at the 3rd Month After Surgery
|
2.25 L
Standard Deviation 0.52
|
2.37 L
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: up to 24 weeksOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Postoperative Hospital Stay
|
4.75 days
Standard Deviation 2.38
|
4.24 days
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: up to 24 weeksOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Postoperative ICU Stay
With ICU stays
|
0 Participants
|
1 Participants
|
|
Postoperative ICU Stay
Without ICU stays
|
32 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeksOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Duration of Drainage
|
3.91 days
Standard Deviation 2.47
|
3.27 days
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: postoperative in-hospital stay up to 30 daysOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Mortality in 30 Days After Surgery
|
0 case
|
0 case
|
SECONDARY outcome
Timeframe: First day after surgeryThe duration of chest drainage was different, so we analyzed the drainage volume the first day after surgery of each patient.
Outcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Drainage Volume of the First Day After Surgery
|
176 Milliliter
Standard Deviation 122.53
|
142 Milliliter
Standard Deviation 94.98
|
SECONDARY outcome
Timeframe: During drainage time, up to 4 weeksPopulation: Data were not collected. Because we found digital drainage system only collect the air leakage rate but not the air leakage volume
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During surgeryOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Duration of Surgery
|
138.4 min
Standard Deviation 35.9
|
143.0 min
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: During surgeryOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Blood Loss During Surgery
|
100 ml
Interval 100.0 to 100.0
|
100 ml
Interval 75.0 to 200.0
|
SECONDARY outcome
Timeframe: During surgeryProportion of converting to thoracotomy。
Outcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Number of Conversions
|
0 case
|
0 case
|
SECONDARY outcome
Timeframe: 2 weeks after surgeryOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Participants With Malignant Tumors
|
27 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: During hospital stay, up to 24 weeksOutcome measures
| Measure |
Energy Instruments Group
n=32 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 Participants
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Medical Costs
Cost of medical materials
|
4214.6 USD
Standard Deviation 1185.4
|
3260.1 USD
Standard Deviation 352.6
|
|
Medical Costs
Total medical cost
|
11136.2 USD
Standard Deviation 1902.0
|
111602.5 USD
Standard Deviation 2788.9
|
Adverse Events
Energy Instruments Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Stapling Device Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Energy Instruments Group
n=32 participants at risk
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
|
Stapling Device Group
n=33 participants at risk
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
Stapling Device: Stapling Device, including linear stapler and curved stapler.
|
|---|---|---|
|
Infections and infestations
Septic shock
|
0.00%
0/32 • Three months after surgery.
The adverse events occurred were described.
|
3.0%
1/33 • Three months after surgery.
The adverse events occurred were described.
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
1/32 • Three months after surgery.
The adverse events occurred were described.
|
0.00%
0/33 • Three months after surgery.
The adverse events occurred were described.
|
Other adverse events
Adverse event data not reported
Additional Information
Prof. Hecheng Li, Chair of Thoracic Surgery
Ruijin Hospital Shanghai JiaoTong University School of Medicine
Phone: (86)13917113402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place