NCT02628093

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 6, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

3.2 years

First QC Date

December 4, 2015

Results QC Date

November 22, 2019

Last Update Submit

March 4, 2020

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

  • Overall Time for Dissection of the Soft Tissues

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

    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.

    Day 0 Surgical procedure

Secondary Outcomes (5)

  • Length of Post Surgical Stay in the Hospital

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

  • Dryness of the Surgical Field Average Score Mean/sd

    Day 0 Surgical Procedure

  • Intraoperative Complication Related to the Energy Devices

    Day 0 Surgical procedure

  • Delayed Thermal Injuries Related to Energy Devices

    DAY 1 to DAY 30 Postsurgery

  • Operative Procedure Time

    Day 0 Surgical Procedure

Study Arms (2)

THUNDERBEAT

OTHER

THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels

Device: THUNDERBEAT

LIGASURE

OTHER

LIGASURE energy device will be used for dissection of tissue and ligation of vessels

Device: LIGASURE

Interventions

THUNDERBEATDEVICE

Tissue dissection and vessels ligation

THUNDERBEAT
LIGASUREDEVICE

Tissue dissection and vessels ligation

LIGASURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical Center- NYPH

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 34724584DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Koianka Trencheva
Organization
Weill Cornell Medicine
kivanova@med.cornell.edu
646-9622342

Study Officials

  • Jeffrey Milsom, MD

    WCMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 11, 2015

Study Start

February 17, 2016

Primary Completion

May 2, 2019

Study Completion

May 2, 2019

Last Updated

March 18, 2020

Results First Posted

February 6, 2020

Record last verified: 2020-03

Locations

US(1)