Colon Cancer
Conditions
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
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.
Interventions
DEVICETHUNDERBEAT
Tissue dissection and vessels ligation
DEVICELIGASURE
Tissue dissection and vessels ligation
Sponsors
Olympus
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
| 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 . |
Countries
United States
Participant flow
Pre-assignment details
73 subjects were enrolled, and 60 of them were randomized into the two groups.
Participants by arm
| Arm | Count |
|---|---|
| THUNDERBEAT THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels
THUNDERBEAT: Tissue dissection and vessels ligation | 31 |
| LIGASURE LIGASURE energy device will be used for dissection of tissue and ligation of vessels
LIGASURE: Tissue dissection and vessels ligation | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | THUNDERBEAT | LIGASURE | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 63 years | 59.5 years |
| ASA Class | 2 scores on a scale | 2 scores on a scale | 2 scores on a scale |
| Body mass index(BMI) | 26.3 kgm^2 STANDARD_DEVIATION 4.3 | 26.4 kgm^2 STANDARD_DEVIATION 4 | 26.3 kgm^2 STANDARD_DEVIATION 4.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 3 / 31 | 9 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Overall Time for Dissection of the Soft Tissues
from the start of colon mobilization to specimen removal from the abdominal cavity
Time frame: Day 0 Surgical procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| THUNDERBEAT | Overall Time for Dissection of the Soft Tissues | 91 minutes |
| LIGASURE | Overall Time for Dissection of the Soft Tissues | 77 minutes |
Comparison: 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.p-value: 0.214Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 0 Surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THUNDERBEAT | Versatility Score | 4.8 score on a scale | Standard Deviation 0.18 |
| LIGASURE | Versatility Score | 4.7 score on a scale | Standard Deviation 0.22 |
Comparison: compared between groups by the Wilcoxon rank-sum testp-value: 0.007Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: DAY 1 to DAY 30 Postsurgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THUNDERBEAT | Delayed Thermal Injuries Related to Energy Devices | 0 percentage of total number in the group |
| LIGASURE | Delayed Thermal Injuries Related to Energy Devices | 0 percentage of total number in the group |
p-value: 1Fisher Exact
Secondary
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 .
Time frame: Day 0 Surgical Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THUNDERBEAT | Dryness of the Surgical Field Average Score Mean/sd | 4.5 score on a scale | Standard Deviation 0.38 |
| LIGASURE | Dryness of the Surgical Field Average Score Mean/sd | 4.4 score on a scale | Standard Deviation 0.33 |
Secondary
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
Time frame: Day 0 Surgical procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| THUNDERBEAT | Intraoperative Complication Related to the Energy Devices | 0 percentage of total in the group |
| LIGASURE | Intraoperative Complication Related to the Energy Devices | 0 percentage of total in the group |
Secondary
Length of Post Surgical Stay in the Hospital
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THUNDERBEAT | Length of Post Surgical Stay in the Hospital | 4.5 days | Standard Deviation 3.1 |
| LIGASURE | Length of Post Surgical Stay in the Hospital | 5.3 days | Standard Deviation 3.9 |
Secondary
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
Time frame: Day 0 Surgical Procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| THUNDERBEAT | Operative Procedure Time | 176 minutes |
| LIGASURE | Operative Procedure Time | 170 minutes |