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| Name | Class |
|---|---|
| Olympus | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THUNDERBEAT | Other | THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels |
|
| LIGASURE | Other | LIGASURE energy device will be used for dissection of tissue and ligation of vessels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THUNDERBEAT | Device | Tissue dissection and vessels ligation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Post Surgical Stay in the Hospital | Length of post surgical stay in the hospital measured in days | from Surgery date to the discharge date from the hospital up to 30 days |
| Dryness of the Surgical Field Average Score Mean/sd |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Milsom, MD | WCMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical Center- NYPH | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34724584 | Derived | 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. |
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73 subjects were enrolled, and 60 of them were randomized into the two groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | THUNDERBEAT | THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation |
| FG001 | LIGASURE | LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | THUNDERBEAT | THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation |
| BG001 | LIGASURE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Time for Dissection of the Soft Tissues | from the start of colon mobilization to specimen removal from the abdominal cavity | Posted | Median | Full Range | minutes | Day 0 Surgical procedure |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | THUNDERBEAT | THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative Rectal Bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Koianka Trencheva | Weill Cornell Medicine | 646-9622342 | kivanova@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2019 | Nov 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| LIGASURE |
| Device |
Tissue dissection and vessels ligation |
|
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 .
| 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" | 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". | 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 | Day 0 Surgical Procedure |
LIGASURE energy device will be used for dissection of tissue and ligation of vessels
LIGASURE: Tissue dissection and vessels ligation
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index(BMI) | BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. | Mean | Standard Deviation | kgm^2 |
|
| ASA Class | American Society of Anesthesiologists Classification (ASA Class) and has 6 levels plus an indicator "E" for an emergency cases.ASA 1: A normal healthy patient, ASA 2: A patient with a mild systemic disease,ASA 3: A patient with a severe systemic disease that is not life-threatening, to ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient.This trial enrolled patients with ASA 1 to 3. | Median | Full Range | scores on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 0 Surgical procedure |
|
|
|
|
| Secondary | Length of Post Surgical Stay in the Hospital | Length of post surgical stay in the hospital measured in days | Posted | Mean | Standard Deviation | days | from Surgery date to the discharge date from the hospital up to 30 days |
|
|
|
| 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 . | Posted | Mean | Standard Deviation | score on a scale | Day 0 Surgical Procedure |
|
|
|
| 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" | Posted | Number | percentage of total in the group | Day 0 Surgical procedure |
|
|
|
| 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". | Posted | Number | percentage of total number in the group | DAY 1 to DAY 30 Postsurgery |
|
|
|
|
| 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 | Posted | Median | Full Range | minutes | Day 0 Surgical Procedure |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 3 |
| 31 |
| EG001 | LIGASURE | LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation | 0 | 29 | 0 | 29 | 9 | 29 |
| Anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound hematoma incision | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |