Trial Outcomes & Findings for A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery (NCT NCT02628093)

Results Overview

from the start of colon mobilization to specimen removal from the abdominal cavity

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

Day 0 Surgical procedure

Results posted on

2020-03-18

Participant Flow

73 subjects were enrolled, and 60 of them were randomized into the two groups.

Participant milestones

Participant milestones
Measure	THUNDERBEAT THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Overall Study STARTED	31	29
Overall Study COMPLETED	31	29
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

Baseline characteristics by cohort
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation	Total n=60 Participants Total of all reporting groups
Age, Continuous	54 years n=31 Participants	63 years n=29 Participants	59.5 years n=60 Participants
Sex: Female, Male Female	14 Participants n=31 Participants	17 Participants n=29 Participants	31 Participants n=60 Participants
Sex: Female, Male Male	17 Participants n=31 Participants	12 Participants n=29 Participants	29 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	31 participants n=31 Participants	29 participants n=29 Participants	60 participants n=60 Participants
Body mass index(BMI)	26.3 kgm^2 STANDARD_DEVIATION 4.3 • n=31 Participants	26.4 kgm^2 STANDARD_DEVIATION 4 • n=29 Participants	26.3 kgm^2 STANDARD_DEVIATION 4.2 • n=60 Participants
ASA Class	2 scores on a scale n=31 Participants	2 scores on a scale n=29 Participants	2 scores on a scale n=60 Participants

PRIMARY outcome

Timeframe: Day 0 Surgical procedure

from the start of colon mobilization to specimen removal from the abdominal cavity

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Overall Time for Dissection of the Soft Tissues	91 minutes Interval 41.0 to 172.0	77 minutes Interval 38.0 to 175.0

PRIMARY outcome

Timeframe: Day 0 Surgical procedure

Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average.

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Versatility Score	4.8 score on a scale Standard Deviation 0.18	4.7 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: from Surgery date to the discharge date from the hospital up to 30 days

Length of post surgical stay in the hospital measured in days

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Length of Post Surgical Stay in the Hospital	4.5 days Standard Deviation 3.1	5.3 days Standard Deviation 3.9

SECONDARY outcome

Timeframe: Day 0 Surgical Procedure

Measured by score from 1 to 5 where 1 means Heavy bleeding , hemostasis achieved with the instrument with more than 2 attempts, and 5 means No oozing at vessel or tissue site in entire surgical field .

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Dryness of the Surgical Field Average Score Mean/sd	4.5 score on a scale Standard Deviation 0.38	4.4 score on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: Day 0 Surgical procedure

Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Intraoperative Complication Related to the Energy Devices	0 percentage of total in the group	0 percentage of total in the group

SECONDARY outcome

Timeframe: DAY 1 to DAY 30 Postsurgery

Delayed thermal injuries related to Energy devices that occur after surgery within 30 days of the surgical date, measured as categorical variables "Yes" or "No".

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Delayed Thermal Injuries Related to Energy Devices	0 percentage of total number in the group	0 percentage of total number in the group

SECONDARY outcome

Timeframe: Day 0 Surgical Procedure

operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision

Outcome measures

Outcome measures
Measure	THUNDERBEAT n=31 Participants THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 Participants LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Operative Procedure Time	176 minutes Interval 113.0 to 270.0	170 minutes Interval 98.0 to 265.0

Adverse Events

THUNDERBEAT

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LIGASURE

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	THUNDERBEAT n=31 participants at risk THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE n=29 participants at risk LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Injury, poisoning and procedural complications Postoperative Rectal Bleeding	9.7% 3/31 • 30 days Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.	13.8% 4/29 • 30 days Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/31 • 30 days Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.	6.9% 2/29 • 30 days Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.
Injury, poisoning and procedural complications Wound hematoma incision	0.00% 0/31 • 30 days Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.	10.3% 3/29 • 30 days Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.

Additional Information

Koianka Trencheva

Weill Cornell Medicine

Phone: 646-9622342

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place