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Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192904
Recruitment Status : Terminated (One treatment policy showed an advantage at a very high significance level.)
First Posted : June 20, 2017
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hecheng Li M.D., Ph.D, Ruijin Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Segmentectomy
Interventions Device: Energy Instruments
Device: Stapling Device
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 35 35
Completed 32 33
Not Completed 3 2
Reason Not Completed
Physician Decision             3             1
Lost to Follow-up             0             1
Arm/Group Title Energy Instruments Group Stapling Device Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 32 33 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 33 participants 65 participants
52.2  (10.4) 53.3  (10.7) 52.7  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
Female
21
  65.6%
20
  60.6%
41
  63.1%
Male
11
  34.4%
13
  39.4%
24
  36.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
32
 100.0%
33
 100.0%
65
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 32 participants 33 participants 65 participants
32 33 65
Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
6
  18.8%
3
   9.1%
9
  13.8%
Comorbidity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
10
  31.3%
11
  33.3%
21
  32.3%
ASA Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
I
0
   0.0%
3
   9.1%
3
   4.6%
II
31
  96.9%
29
  87.9%
60
  92.3%
III
1
   3.1%
1
   3.0%
2
   3.1%
[1]
Measure Description:

American Society of Anesthesiologists (ASA) grade is the most commonly used grading system that predicts morbidity and mortality.

I: Healthy individual with no systemic disease, MORTALITY 0.05% II: Mild systemic disease not limiting activity, MORTALITY 0.4% III: Severe systemic disease that limits activity but is not incapacitating , MORTALITY 4.5% IV: Incapacitating systemic disease which is constantly life-threatening , MORTALITY 25% V: Moribund, not expected to survive 24 hours with or without surgery , MORTALITY 50%

Segments resected  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
RS1
9
  28.1%
5
  15.2%
14
  21.5%
RS2
0
   0.0%
3
   9.1%
3
   4.6%
RS3
2
   6.3%
1
   3.0%
3
   4.6%
RS6
2
   6.3%
4
  12.1%
6
   9.2%
RS8
1
   3.1%
0
   0.0%
1
   1.5%
RS1+RS2
0
   0.0%
1
   3.0%
1
   1.5%
RS9+RS10
1
   3.1%
0
   0.0%
1
   1.5%
RS1a+RS2
0
   0.0%
2
   6.1%
2
   3.1%
RS1b+RS3
0
   0.0%
1
   3.0%
1
   1.5%
RS1b+RS3b
0
   0.0%
1
   3.0%
1
   1.5%
RS2b+RS3a
0
   0.0%
1
   3.0%
1
   1.5%
RS8b+RS9
1
   3.1%
0
   0.0%
1
   1.5%
LS1+2
7
  21.9%
1
   3.0%
8
  12.3%
LS3
1
   3.1%
1
   3.0%
2
   3.1%
LS6
3
   9.4%
1
   3.0%
4
   6.2%
LS9
1
   3.1%
0
   0.0%
1
   1.5%
LS10
0
   0.0%
1
   3.0%
1
   1.5%
LS1+2+LS3
2
   6.3%
4
  12.1%
6
   9.2%
LS4+LS5
1
   3.1%
3
   9.1%
4
   6.2%
LS6+LS8
0
   0.0%
1
   3.0%
1
   1.5%
LS7+LS8+LS9+LS10
0
   0.0%
1
   3.0%
1
   1.5%
LS3c
1
   3.1%
0
   0.0%
1
   1.5%
LS1+2+LS3c
0
   0.0%
1
   3.0%
1
   1.5%
Approaches(Video-Assisted Thoracic Surgery or Robotic)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
Video-Assisted Thoracic Surgery
5
  15.6%
10
  30.3%
15
  23.1%
Robotic
27
  84.4%
23
  69.7%
50
  76.9%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 32 participants 33 participants 65 participants
162.9  (6.7) 164.5  (7.7) 163.7  (7.2)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 32 participants 33 participants 65 participants
60.0  (8.1) 63.4  (8.7) 61.7  (8.4)
1.Primary Outcome
Title Incidence of Postoperative Complications
Hide Description 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).
Time Frame postoperative in-hospital stay up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Measure Type: Count of Participants
Unit of Measure: Participants
11
  34.4%
2
   6.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Energy Instruments Group, Stapling Device Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Incidence Rates of Each Postoperative Complications
Hide Description [Not Specified]
Time Frame postoperative in-hospital stay up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Measure Type: Count of Participants
Unit of Measure: Participants
Air leakage
7
  21.9%
1
   3.0%
Pneumothorax
3
   9.4%
0
   0.0%
Septic shock
0
   0.0%
1
   3.0%
Cardiac arrest
1
   3.1%
0
   0.0%
No complications
21
  65.6%
31
  93.9%
3.Secondary Outcome
Title Preoperative Lung Function
Hide Description [Not Specified]
Time Frame Baseline.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: L
2.73  (0.50) 2.80  (0.74)
4.Secondary Outcome
Title Postoperative Lung Function at the 3rd Month After Surgery
Hide Description [Not Specified]
Time Frame at the 3rd month after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: L
2.25  (0.52) 2.37  (0.62)
5.Secondary Outcome
Title Postoperative Hospital Stay
Hide Description [Not Specified]
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: days
4.75  (2.38) 4.24  (2.00)
6.Secondary Outcome
Title Postoperative ICU Stay
Hide Description [Not Specified]
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Measure Type: Count of Participants
Unit of Measure: Participants
With ICU stays
0
   0.0%
1
   3.0%
Without ICU stays
32
 100.0%
32
  97.0%
7.Secondary Outcome
Title Duration of Drainage
Hide Description [Not Specified]
Time Frame up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: days
3.91  (2.47) 3.27  (1.53)
8.Secondary Outcome
Title Mortality in 30 Days After Surgery
Hide Description [Not Specified]
Time Frame postoperative in-hospital stay up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Measure Type: Number
Unit of Measure: case
0 0
9.Secondary Outcome
Title Drainage Volume of the First Day After Surgery
Hide Description The duration of chest drainage was different, so we analyzed the drainage volume the first day after surgery of each patient.
Time Frame First day after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: Milliliter
176  (122.53) 142  (94.98)
10.Secondary Outcome
Title Daily Air Leakage Volume
Hide Description [Not Specified]
Time Frame During drainage time, up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected. Because we found digital drainage system only collect the air leakage rate but not the air leakage volume
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Duration of Surgery
Hide Description [Not Specified]
Time Frame During surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: min
138.4  (35.9) 143.0  (35.7)
12.Secondary Outcome
Title Blood Loss During Surgery
Hide Description [Not Specified]
Time Frame During surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Median (Inter-Quartile Range)
Unit of Measure: ml
100
(100 to 100)
100
(75 to 200)
13.Secondary Outcome
Title Number of Conversions
Hide Description Proportion of converting to thoracotomy。
Time Frame During surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Measure Type: Number
Unit of Measure: case
0 0
14.Secondary Outcome
Title Participants With Malignant Tumors
Hide Description [Not Specified]
Time Frame 2 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Measure Type: Count of Participants
Unit of Measure: Participants
27
  84.4%
30
  90.9%
15.Secondary Outcome
Title Medical Costs
Hide Description [Not Specified]
Time Frame During hospital stay, up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 32 33
Mean (Standard Deviation)
Unit of Measure: USD
Cost of medical materials 4214.6  (1185.4) 3260.1  (352.6)
Total medical cost 11136.2  (1902.0) 111602.5  (2788.9)
Time Frame Three months after surgery.
Adverse Event Reporting Description The adverse events occurred were described.
 
Arm/Group Title Energy Instruments Group Stapling Device Group
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Energy Instruments Group Stapling Device Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
Energy Instruments Group Stapling Device Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/32 (3.13%)   1/33 (3.03%) 
Cardiac disorders     
Cardiac arrest *  1/32 (3.13%)  0/33 (0.00%) 
Infections and infestations     
Septic shock *  0/32 (0.00%)  1/33 (3.03%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Energy Instruments Group Stapling Device Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/33 (0.00%) 
First, we only used electrocautery to divide intersegmental planes in the energy instrument group. Second, the single-center design might lead to selection bias. Third, oncological outcomes were not available.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Hecheng Li, Chair of Thoracic Surgery
Organization: Ruijin Hospital Shanghai JiaoTong University School of Medicine
Phone: (86)13917113402
EMail: lihecheng2000@hotmail.com
Layout table for additonal information
Responsible Party: Hecheng Li M.D., Ph.D, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03192904    
Other Study ID Numbers: RuijinH-2017059
First Submitted: June 12, 2017
First Posted: June 20, 2017
Results First Submitted: September 11, 2018
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020