A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02628093
• Collaborator: Olympus (Industry)
• Enrollment: 73
• Location: 1
• Arms: 2
• Actual Duration (Months): 38.4
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2

• Ligasure Population

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Device: THUNDERBEAT; Device: LIGASURE	N/A

Detailed Description

Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2

• Ligasure Population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary Study Procedures: This project will consist only of prospective data collection. No interventions will be done for research purpose. Data will be collected prospectively on: -Patients (before, during and after surgery) -The THUNDERBEAT and LigaSure instruments Data will be collected on data collection sheets and entered in a password protected database Primary Outcomes/Definitions- Overall time for dissection of the soft tissues necessary for specimen removal during colon resection, measured in minutes, from the start of colon mobilization to specimen removal from the abdominal cavity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
• Actual Study Start Date: Feb 17, 2016
• Actual Primary Completion Date: May 2, 2019
• Actual Study Completion Date: May 2, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: THUNDERBEAT THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels	Device: THUNDERBEAT; Tissue dissection and vessels ligation
Other: LIGASURE LIGASURE energy device will be used for dissection of tissue and ligation of vessels	Device: LIGASURE; Tissue dissection and vessels ligation

Outcome Measures

Primary Outcome Measures

1. Overall Time for Dissection of the Soft Tissues [Day 0 Surgical procedure]

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

2. Versatility Score [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.

Secondary Outcome Measures

1. Length of Post Surgical Stay in the Hospital [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

2. Dryness of the Surgical Field Average Score Mean/sd [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 .

3. Intraoperative Complication Related to the Energy Devices [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"

4. Delayed Thermal Injuries Related to Energy Devices [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".

5. Operative Procedure Time [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients that will be undergoing a Left Laparoscopic Colon Resection

• Older than 18 years old

• ASA 1 to 3

• Elective surgeries

• Patients who willingly provide informed consent

Exclusion Criteria:

• Morbidly obese patients (BMI >35)

• Patients with acute diverticulitis

• Patients with multiple previous abdominal surgeries

• Patients on anticoagulants

• Patients who can not, tolerate a major surgery

• Patients for whom electrosurgery is contraindicated

• Patients who are pregnant

• Patient with IBDs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical Center- NYPH	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University
• Olympus

Investigators

• Principal Investigator: Jeffrey Milsom, MD, WCMC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 8, 2019

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02628093
• Other Study ID Numbers: 1403014955
• First Posted: Dec 11, 2015
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	73 subjects were enrolled, and 60 of them were randomized into the two groups.

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Period Title: Overall Study
STARTED	31	29
COMPLETED	31	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	THUNDERBEAT	LIGASURE	Total
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation	Total of all reporting groups
Overall Participants	31	29	60
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	54	63	59.5
Sex: Female, Male (Count of Participants)
Female	14 45.2%	17 58.6%	31 51.7%
Male	17 54.8%	12 41.4%	29 48.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	31 100%	29 100%	60 100%
Body mass index(BMI) (kgm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kgm^2]	26.3 (4.3)	26.4 (4)	26.3 (4.2)
ASA Class (scores on a scale) [Median (Full Range) ]
Median (Full Range) [scores on a scale]	2	2	2

Outcome Measures

1. Primary Outcome

Title	Overall Time for Dissection of the Soft Tissues
Description	from the start of colon mobilization to specimen removal from the abdominal cavity
Time Frame	Day 0 Surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Median (Full Range) [minutes]	91	77

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THUNDERBEAT, LIGASURE
	Comments	Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.
	Type of Statistical Test	Other
	Comments	Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.
Statistical Test of Hypothesis	p-Value	0.214
	Comments	P value threshold <0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Versatility Score
Description	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.
Time Frame	Day 0 Surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Mean (Standard Deviation) [score on a scale]	4.8 (0.18)	4.7 (0.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THUNDERBEAT, LIGASURE
	Comments	compared between groups by the Wilcoxon rank-sum test
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments	P value threshold <0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Length of Post Surgical Stay in the Hospital
Description	Length of post surgical stay in the hospital measured in days
Time Frame	from Surgery date to the discharge date from the hospital up to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Mean (Standard Deviation) [days]	4.5 (3.1)	5.3 (3.9)

4. Secondary Outcome

Title	Dryness of the Surgical Field Average Score Mean/sd
Description	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 .
Time Frame	Day 0 Surgical Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Mean (Standard Deviation) [score on a scale]	4.5 (0.38)	4.4 (0.33)

5. Secondary Outcome

Title	Intraoperative Complication Related to the Energy Devices
Description	Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"
Time Frame	Day 0 Surgical procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Number [percentage of total in the group]	0	0

6. Secondary Outcome

Title	Delayed Thermal Injuries Related to Energy Devices
Description	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".
Time Frame	DAY 1 to DAY 30 Postsurgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Number [percentage of total number in the group]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	THUNDERBEAT, LIGASURE
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments	P value threshold <0.05
	Method	Fisher Exact
	Comments

7. Secondary Outcome

Title	Operative Procedure Time
Description	operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision
Time Frame	Day 0 Surgical Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THUNDERBEAT	LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation	LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
Measure Participants	31	29
Median (Full Range) [minutes]	176	170

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	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.
Arm/Group Title	THUNDERBEAT		LIGASURE
Arm/Group Description	THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation		LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation
All Cause Mortality
	THUNDERBEAT		LIGASURE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Serious Adverse Events
	THUNDERBEAT		LIGASURE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	THUNDERBEAT		LIGASURE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/31 (9.7%)		9/29 (31%)
Injury, poisoning and procedural complications
Postoperative Rectal Bleeding	3/31 (9.7%)		4/29 (13.8%)
Anastomotic leak	0/31 (0%)		2/29 (6.9%)
Wound hematoma incision	0/31 (0%)		3/29 (10.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.