Trial Outcomes & Findings for Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy (NCT NCT03125798)
NCT ID: NCT03125798
Last Updated: 2024-09-03
Results Overview
Measurement of the postoperative volume of fluid drained in milliliters, measured up to chest drain removal, average 3 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
Total postoperative chest drainage volume
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
LigaSure
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
107
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
LigaSure
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
|---|---|---|
|
Overall Study
Lack of electrosurgical device in the operating room
|
2
|
0
|
|
Overall Study
Conversion to thoracotomy
|
7
|
7
|
Baseline Characteristics
Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy
Baseline characteristics by cohort
| Measure |
LigaSure
n=100 Participants
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
n=100 Participants
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Total postoperative chest drainage volumeMeasurement of the postoperative volume of fluid drained in milliliters, measured up to chest drain removal, average 3 days.
Outcome measures
| Measure |
LigaSure
n=100 Participants
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
n=100 Participants
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
|---|---|---|
|
Postoperative Chest Drainage Volume up to Chest Drain Removal, Average 3 Days.
|
550 ml
Interval 335.0 to 905.0
|
580 ml
Interval 352.0 to 950.0
|
SECONDARY outcome
Timeframe: 72 hours after surgeryChange in C-reactive protein (CRP) level, calculated as the difference between CRP values \[mg/L\] at 72 hours after surgery and 24 hours before surgery
Outcome measures
| Measure |
LigaSure
n=98 Participants
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
n=95 Participants
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
|---|---|---|
|
Acute Phase Proteins Levels.
|
68.5 mg/L
Interval 37.9 to 116.0
|
69.2 mg/L
Interval 44.8 to 107.4
|
SECONDARY outcome
Timeframe: During mediastinal lymph nodes dissection (during surgery)Change in the intraesophageal temperature at the level of the subcarinal lymph nodes, calculated as the difference between the highest temperature during subcarinal nodes dissection and the temperature before subcarinal nodes dissection
Outcome measures
| Measure |
LigaSure
n=87 Participants
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
n=88 Participants
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
|---|---|---|
|
Local Temperature.
|
-0.1 degree Celcius
Interval -0.2 to 0.1
|
-0.1 degree Celcius
Interval -0.2 to 0.1
|
Adverse Events
LigaSure
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Monopolar Electrocautery
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LigaSure
n=100 participants at risk
In this arm, LigaSure™ will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
LigaSure™: LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
|
Monopolar Electrocautery
n=100 participants at risk
In this arm, conventional monopolar electrocautery will be used for mediastinal lymph nodes dissection, according to standard surgical technique.
Monopolar electrocautery: Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
|
|---|---|---|
|
Surgical and medical procedures
Prolonged air leak
|
10.0%
10/100 • Data were collected from the beginning of the intervention (first use of the LigaSure device or monopolar device during surgery) until hospital discharge, an average of 1 week"
|
12.0%
12/100 • Data were collected from the beginning of the intervention (first use of the LigaSure device or monopolar device during surgery) until hospital discharge, an average of 1 week"
|
|
Surgical and medical procedures
Residual air space
|
8.0%
8/100 • Data were collected from the beginning of the intervention (first use of the LigaSure device or monopolar device during surgery) until hospital discharge, an average of 1 week"
|
7.0%
7/100 • Data were collected from the beginning of the intervention (first use of the LigaSure device or monopolar device during surgery) until hospital discharge, an average of 1 week"
|
|
Surgical and medical procedures
Atrial fibrillation
|
6.0%
6/100 • Data were collected from the beginning of the intervention (first use of the LigaSure device or monopolar device during surgery) until hospital discharge, an average of 1 week"
|
3.0%
3/100 • Data were collected from the beginning of the intervention (first use of the LigaSure device or monopolar device during surgery) until hospital discharge, an average of 1 week"
|
Additional Information
Dr Piotr Gabryel
Wielkoposkie Centrum Pulmonologii i Torakochirurgii
Phone: +48616654249
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place