Colon CancerNCT02628093
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
A study testing THUNDERBEAT and LIGASURE in people with Colon Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- THUNDERBEAT and LIGASURE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2016to 2 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical Center- NYPH
New York, New York, 10065
About this study
Official title: A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
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
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- THUNDERBEAT, LIGASURE
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THUNDERBEATDevice
Tissue dissection and vessels ligation
LIGASUREDevice
Tissue dissection and vessels ligation
| Study group | Role | What they receive |
|---|---|---|
| THUNDERBEAT | Other | THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels Receives: Device: THUNDERBEAT |
| LIGASURE | Other | LIGASURE energy device will be used for dissection of tissue and ligation of vessels Receives: Device: LIGASURE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Time for Dissection of the Soft Tissues
from the start of colon mobilization to specimen removal from the abdominal cavity
Measured: Day 0 Surgical procedure
Versatility Score
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.
Measured: Day 0 Surgical procedure
Secondary outcomes (5)
Length of Post Surgical Stay in the Hospital
Length of post surgical stay in the hospital measured in days
Measured: from Surgery date to the discharge date from the hospital up to 30 days
Dryness of the Surgical Field Average Score Mean/sd
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 .
Measured: Day 0 Surgical Procedure
Intraoperative Complication Related to the Energy Devices
Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"
Measured: Day 0 Surgical procedure
Delayed Thermal Injuries Related to Energy Devices
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".
Measured: DAY 1 to DAY 30 Postsurgery
Operative Procedure Time
operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision
Measured: Day 0 Surgical Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start17 Feb 2016
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Sponsor
- Investigators
- Jeffrey Milsom, MD, Principal investigator, WCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628093
- Sponsor's protocol ID
- 1403014955
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2015
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Milsom JW, Trencheva K, Momose K, Peev MP, Christos P, Shukla PJ, Garrett K. A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery. Surg Endosc. 2022 Jun;36(6):4265-4274. doi: 10.1007/s00464-021-08765-8. Epub 2021 Nov 1.
PubMed 34724584
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
- ClinicalTrials.gov ID
- NCT02628093
- Acronym / sponsor ID
- 1403014955
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 6 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THUNDERBEAT | Other | Device: THUNDERBEATTHUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels |
| LIGASURE | Other | Device: LIGASURELIGASURE energy device will be used for dissection of tissue and ligation of vessels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THUNDERBEATTissue dissection and vessels ligation | Device | THUNDERBEAT |
| LIGASURETissue dissection and vessels ligation | Device | LIGASURE |
Primary outcome
Overall Time for Dissection of the Soft Tissues
Time frame: Day 0 Surgical procedure
from the start of colon mobilization to specimen removal from the abdominal cavity
Versatility Score
Time frame: 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.
5 secondary outcomes
Length of Post Surgical Stay in the Hospital
Time frame: from Surgery date to the discharge date from the hospital up to 30 days
Dryness of the Surgical Field Average Score Mean/sd
Time frame: Day 0 Surgical Procedure
Intraoperative Complication Related to the Energy Devices
Time frame: Day 0 Surgical procedure
Delayed Thermal Injuries Related to Energy Devices
Time frame: DAY 1 to DAY 30 Postsurgery
Operative Procedure Time
Time frame: Day 0 Surgical Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34724584Milsom JW, Trencheva K, Momose K, Peev MP, Christos P, Shukla PJ, Garrett K. A pilot randomized controlled trial comparing THUNDERBEAT to the Maryland LigaSure energy device in laparoscopic left colon surgery. Surg Endosc. 2022 Jun;36(6):4265-4274. doi: 10.1007/s00464-021-08765-8. Epub 2021 Nov 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Milsom, MD principal investigator
WCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THUNDERBEAT and LIGASURE in people with Colon Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Time for Dissection of the Soft Tissues (time frame: Day 0 Surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02628093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.