Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

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

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

THUNDERBEAT

LIGASURE

Jeffrey Milsom, MD

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.

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

A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery

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

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.

Length of post surgical stay in the hospital measured in days

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 .

Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable "Yes" or "No"

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".

operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision

Olympus

Weill Medical College of Cornell University

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.

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

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.

Body mass index(BMI)

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.

ASA Class

Koianka Trencheva

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.

Overall Time for Dissection of the Soft Tissues

compared between groups by the Wilcoxon rank-sum test

Versatility Score

Length of Post Surgical Stay in the Hospital

Dryness of the Surgical Field Average Score Mean/sd

Intraoperative Complication Related to the Energy Devices

Delayed Thermal Injuries Related to Energy Devices

Operative Procedure Time

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Coagulants

Hemostatics

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery.

A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope.

Two additional 5 mm ports are placed under direct visualization. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.

Laparoscopic total hysterectomy with pelvic lymphadenectomy are performed with Thunderbeat technology: using Thunderbeat technique, surgeons can avoid changing instruments during surgery since Thunderbeat combines bipolar energy for haemostasis and ultrasound for dissection and cut.

Thunderbeat is used to coagulate the fallopian tubes, to coagulate and divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to incise the bladder peritoneum, to dissect the bladder, to develop rectovaginal septum, to cut parametria, and to divide the uterosacral ligaments. Thunderbeat is also used to perform the pelvic lymphadenectomy and, if necessary, the para-aortic lymphadenectomy.

Thunderbeat technology

Standard bipolar electrosurgery

Catholic University of Sacred the Hearth

Anna Fagotti, PhD

Francesco Fanfani, MD

Valerio Gallotta, MD

Giuseppe Vizzielli, MD

Elisa Piovano, MD

Raffaella Iodice

This prospective randomized pilot study is aimed to verify if the operative time of a TLH with pelvic lymphadenectomy for endometrial cancer FIGO stage IB-II could be reduced using Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .

Secondary endpoints of this comparison are incidence of intra- or postoperative complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.

The standard treatment for early-stage endometrial cancer is surgery. Surgical procedures include washing for cytology, total extrafascial hysterectomy and bilateral salpingo-oophorectomy. Although the therapeutic value of routine pelvic and para-aortic lymphadenectomy is debated, staging information is a critical determinant of adjuvant therapy for most gynecologic oncologists.

Type-1 endometrial cancer spread is limited to the pelvic nodes in most cases. If there are positive lymph nodes, those around the obturator nerve and around the external and common iliac vessels are more likely to be involved than those in the presacral area. Isolated involvement of the para-aortic nodes is rare. Complete excision of the nodes located around the iliac vessels and above the obturator nerve allows identiﬁcation of 90% of node-positive patients.

The decision on whether to undertake lymphadenectomy should not be based on palpation of the nodal area, because less than 10% of patients with nodal metastases have grossly enlarged nodes.

Patients with endometrioid cancer, grade 1-2 with deep myometrial invasion and any grade 3 endometrioid endometrial cancer have at least a 5% risk of having positive pelvic lymph nodes. In our current treatment protocol, these patients undergo complete pelvic lymphadenectomy. Laparotomy may be indicated in endometrial cancer patients presenting with grossly positive pelvic nodes, grossly positive adnexal metastasis, or serosal inﬁltration.

Although the complication rate of a simple hysterectomy with bilateral salpingo-oophorectomy is not very high, over 70% new cases of endometrial cancer are diagnosed in post-menopausal women, commonly associated with medical co-morbidities, such as diabetes, hypertension and obesity. Abdominal surgery therefore exposes them to an increased risk of complications. Vaginal hysterectomy has been suggested as an attractive alternative to abdominal surgery for these patients, but this approach does not allow exploration of the abdominal cavity, peritoneal washing, and lymph-node dissection. Laparoscopic-assisted vaginal hysterectomy or total laparoscopic hysterectomy overcome the previous limitations.

In 1993, Childers et al first proposed laparoscopy as an option for early-stage endometrial cancer. Despite its recognized benefits, many surgeons found this approach difficult for routine use such that relatively few centers offered laparoscopic hysterectomy and lymphadenectomy for a majority of their patients.

From those first reports there have been 12 major reports on the use of laparoscopy, often comparing to series of similar patients staged by laparotomy. Clear advantages, such as the reduction of peri-operative complications, the shorter hospital stay and the earlier recovery, have been confirmed in each series. Failure to complete the staging procedure by laparoscopy ranges between 5 and 35% of the patients, most frequently due to obesity of the patients. In reality in 2005 some researchers have suggested that laparoscopic surgery is safe in obese or elderly patients with endometrial cancer too.

Moreover, this approach does not seem to modify the incidence of recurrence and overall patient survival. The big randomized trials planned to study differences in morbidity and survival between laparoscopy or laparotomy in endometrial cancer are the GOG LAP-2 study, the Dutch study from Bijen and Mourits, and the Australian study LACE. Unfortunately none of these three randomised trials have yet reported survival data, but only on health-related issues and complications. In the GOG study 33, patients with clinical stage I to IIA uterine cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. Laparoscopy resulted in fewer postoperative moderate or severe adverse events, a shorter hospital stay, and a longer operative time than did laparotomy. The median operative time for the open laparotomy arm was 130 minutes (range 102-167 minutes), and for the laparoscopy arm, it was 204 minutes (rang 160-252 minutes; P \< .001).

In the Dutch 34-35 study the major and minor complication rates were the same in the group of patients treated with laparoscopy compared with laparotomy. However, TLH was associated with less blood loss, less use of pain medication, a shorter hospital stay, and a longer operative time than with TAH. The median duration of surgery was 115 minutes in the TLH group, (range 35-267) and 71 minutes (range 31-239) in the TAH group. The difference with the GOG study is probably due to the fact that the patients in the Netherlands only underwent a hysterectomy and bilateral salpingo-oophorectomy and not a complete surgical staging including pelvic and para-aortic lymphadenectomy.

In the Australian LACE study 36 patients with stage I endometrioid adenocarcinoma were randomly assigned to TLH (n=190) or TAH (n=142). Surgeons were required to perform pelvic node (with or without) para-aortic lymph-node dissection as part of the treatment in both groups. Operating time was significantly longer in the TLH group (138 minutes \[SD 43\]) than in the TAH group (109 minutes \[34\]; p=0•001).

Health-related outcome was reported in all three trials. Better physical functioning, body image, reduced pain, and an earlier resumption of work over the 6-week post-laparoscopy period was reported in the GOG and the Dutch study than in the laparotomy patients, but these differences disappeared 6 months after surgery. In the Australian study, quality of life was still improved 6 months after surgery.

In conclusion, laparoscopic treatment of endometrial cancer clinically confined to the uterus is associated with less pain, shorter hospital stay, faster recovery, and better quality of life at least 3 months post surgery, but with a longer operative time than with laparotomy.

Another recent single institution Italian trial randomized patients with clinical stage I endometrial cancer to receive TLH (n=81) or TAH (n=78) with bilateral salpingo-oophorectomy and bilateral pelvic lymphadenectomy. 37 Para-aortic lymphadenectomy was performed in selected cases. The mean operative time was 123 minutes ± 29 (95% CI 111-198) in the LPT group and 136 minutes ± 31 (95% CI 118- 181) in the LPS group (P\<0.01). These operative times match closely with our experience by both laparotomy and laparoscopy, using conventional bipolar electrosurgery.

Shortening the operative time of laparoscopy could further increase the benefits of the laparoscopic approach, especially in obese patients. Overweight (defined as body-mass index \[BMI\] of at least 25 kg/m2) is an important risk factor present in almost 50% of women with endometrial cancer.

Since these patients are characterised by several systemic physiopathological alterations, the perioperative management may present some problems, mainly related to their respiratory system (obstructive sleep apnea, airway intubation and atelectasis). Obstructive sleep apnea-hypopnea syndrome (OSA) occurs in up to 70% of morbidly obese patients undergoing surgery 39 being OSA a known risk factor for adverse perioperative outcomes.

Shortening the operative time could reduce these perioperative complications and the postoperative pain. This could translate in fewer days of hospitalization and than lower incidence of hospital infections and lower costs for the health care system.

Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer

Prospective Randomized Trial on Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Endometrial Cancer FIGO Stage IB-II: Thunderbeat Technology Versus Standard Bipolar Electro-surgery.

Operative time will be calculated from the entrance in the abdominal cavity to the closure of the skin trocar accesses.

Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele

Catholic University of the Sacred Heart

Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente - Policlinico Gemelli, Rome

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with Thunderbeat technology: using Thunderbeat technique, surgeons can avoid changing instruments during surgery since Thunderbeat combines bipolar energy for haemostasis and ultrasound for dissection and cut.

Thunderbeat is used to divide the round ligaments, to seal ovarian pedicles, to open the anterior and posteriors leaves of the broad ligaments peritoneum, to incise the bladder peritoneum, to develop the paravesical and pararectal spaces, to seal uterine arteries and uterine pedicles, to dissect the bladder and develop rectovaginal septum, to unroof the ureter, to cut parametria, and to divide the uterosacral ligaments. Monopolar hook is used in the culdotomy. Thunderbeat is also used to perform pelvic lymphadenectomy.

Laparoscopic radical hysterectomy with pelvic lymphadenectomy are performed with standard bipolar electrosurgery.

A 10 mm port is inserted at the umbilicus for the telescope. Once pneumoperitoneum (12 mmHg) is achieved, intra-abdominal visualization will be obtained with a 0° high-definition telescope.

Two additional 5 mm ports are placed under direct visualization. One more 5-mm trocar is inserted in the right mid abdomen at the level of the umbilicus. The instruments used include bipolar grasper, monopolar scissors, monopolar hook, various graspers and a suction irrigation system.

This prospective randomized pilot study is aimed to verify if the operative time of a LRH with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy with complete clinical response could be reduced using Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .

Secondary endpoints of this comparison are incidence of intra- or postoperative complications, estimated blood loss, postoperative pain, days of hospitalization and costs for the health care system.

Radical abdominal hysterectomy (RAH) with pelvic lymphadenectomy is the standard surgical treatment for early stage cervical carcinoma FIGO stages IA2-IB1-IIA\<2cm1. Since the early 90's laparoscopic radical hysterectomy with pelvic lymphadenectomy (LRH) has been suggested as surgical approach for the treatment of cervical cancer. In the recent years, many institutions have begun to consider it an attractive technique and to study its feasibility and safety. Most of these studies have shown that LRH is relatively more time-consuming than standard laparotomy and ranges from 90 to 420 minutes according to surgeons' experience and different techniques adopted to achieve hemostasis, resect the parametrium and uterosacrals. Spirtos et al. demonstrated that staplers could reduce mean operation time from 253 to 205 minutes if compared to argon beam coagulator. Moreover, the pulsed bipolar system was associated with significant reduction in operative time in comparison with the conventional bipolar system (mean, 172 minutes vs 229 minutes; P \< 0.001). The largest series of LRH reported from a single institution by Puntambekar et al included 248 patients and described the "Pune technique" (anterior and posterior peritoneal U cuts, early dissection of the rectovaginal space, fully mobilization of the uterus, resection of the cardinal and uterosacral ligaments with Ligasure system (Ligasure Vessel Sealing System; Valleylab, Tyco Healthcare, Boulder, CO)), obtaining a very short mean operative time (mean, 92 minutes; range 6-120 minutes).

A recent review on laparoscopic and robot-assisted radical hysterectomy with pelvic lymphadenectomy including 17 studies reported a mean operating time of 202 minutes \[range, 184-221 minutes\] in the group of LRH, which matches with our experience of 210 min (range 180-240), using conventional bipolar electrosurgery.

The aim of this pilot RCT is to verify if the operative time of a LRH with pelvic lymphadenectomy for early stage cervical cancer (FIGO stages IA2-IB1-IIA\<2cm) and for advanced stage cervical cancer (FIGO stages IB2-IIA\>2cm-IIB) submitted to neoadjuvant chemotherapy (NACT) with complete clinical response could be further reduced using Thunderbeat (an ultrasonic energy device that incises and coagulates by using ultrasonic and bipolar technology ) (Olympus Medical Systems Corp, Tokyo) vs. bipolar electrosurgery .

Saving operative time would mean shorter anesthesia and faster recovery, further improving the safety profile of the laparoscopic approach in the treatment of cervical cancer.

Secondary endpoints of this comparison are incidence of intra- or postoperative complications (Cardiac, Respiratory, Neurological, Gastrointestinal, Renal, Fever, Wound or other Infection, Lymphocele), estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.

Thunderbeat Technology vs Standard Bipolar Electro Surgery in Laparoscopic Radical Hysterectomy and Pelvic Lymphadenectomy for Cervical Cancer

Prospective Randomized Trial on Laparoscopic Radical Hysterectomy With Pelvic Lymphadenectomy for the Treatment of Early Stage Cervical Cancer (FIGO Stages IA2-IB1-IIA<2cm) and Advanced Stage Cervical Cancer (FIGO Stages IB2-IIA>2 Cm-IIB) Submitted to NACT With Complete Clinical Response: Thunderbeat Technology Versus Standard Bipolar Electro Surgery

Symptoms and General Pathology

Wounds and Injuries

Rare Diseases

Stomach Neoplasms

Inflammation

Hyperthermia

Fever

Stomach Cancer

Patients group randomized to use ULTRACISION Harmonic Scalpel when receives laparoscopic gastrectomy

Patients group randomized to use Ligasure Maryland when receives laparoscopic gastrectomy

Patients group randomized to use Thunderbeat when receives laparoscopic gastrectomy

to use ULTRACISION Harmonic Scalpel when performing gastrectomy

ULTRACISION Harmonic Scalpel

to use Ligasure Maryland when performing gastrectomy

Ligasure Maryland

to use Thunderbeat when performing gastrectomy

Thunderbeat

Seong-Ho Kong, MD,PhD

To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

1. post operative 2nd day CRP level
2. post operative 4th day CRP level
3. post operative IL-6, 10 level in 2nd, 4th day

Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

Comparison of Perioperative Outcomes Between Bipolar Sealing Device and Ultrasonic Shears During Laparoscopic Gastrectomy for Early Gastric Cancer

To check the postoperative 2nd day CRP level in each group

To check the postoperative 4th day CRP level in each group

To check the postoperative 2nd, 4th day IL-6, IL10 level in each group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery	NCT02628093	Colon Cancer	THUNDERBEAT LIGASURE	18 Years -	Weill Medical College of Cornell University
A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery	NCT02628093	Colon Cancer	THUNDERBEAT LIGASURE	18 Years -	Weill Medical College of Cornell University
Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer	NCT01717794	Endometrial Can...	Thunderbeat tec... Standard bipola...	- 75 Years	Catholic University of the Sacred Heart
Thunderbeat Technology vs Standard Bipolar Electro Surgery in Laparoscopic Radical Hysterectomy and Pelvic Lymphadenectomy for Cervical Cancer	NCT01717781	Cervical Cancer	Thunderbeat tec... Standard bipola...	- 75 Years	Catholic University of the Sacred Heart
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy	NCT03356626	Postoperative I... Postoperative F...	ULTRACISION Har... Ligasure Maryla... Thunderbeat	20 Years - 80 Years	Seoul National University Hospital
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy	NCT03356626	Postoperative I... Postoperative F...	ULTRACISION Har... Ligasure Maryla... Thunderbeat	20 Years - 80 Years	Seoul National University Hospital
Thunderbeat Technology vs Standard Bipolar Electro Surgery in Laparoscopic Radical Hysterectomy and Pelvic Lymphadenectomy for Cervical Cancer	NCT01717781	Cervical Cancer	Thunderbeat tec... Standard bipola...	- 75 Years	Catholic University of the Sacred Heart

Spots Global Cancer Trial Database for thunderbeat

Every month we try and update this database with for thunderbeat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for thunderbeat

Every month we try and update this database with for thunderbeat cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for thunderbeat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.