Blood and Lymph Conditions

All Conditions

Neoplasms

Symptoms and General Pathology

Lymphedema

Lymphocele

Lymphatic Diseases

Cysts

Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)

Harmonic scalpel

Maurice Matter, Prof

Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.

The aim of the present study was to assess the value of USS in RLND in groin and axilla in a homogenous group of patients.

In a tertiary academic centre, patients undergoing groin or axillary RLND or CLND after positive SLNB for melanoma, skin cancer, sarcoma or breast cancer were enrolled in a randomized controlled trial for surgical dissection technique. The study was reviewed and accepted by the local ethical committee. Patients were older than 18 years and gave an informed consent. All patients with a past medical history of contralateral lymph node dissection or other cause of lymphedema (previous trauma, deep venous thrombosis, radiotherapy, etc.) were excluded. Patients undergoing both iliac and inguinal lymph node dissections were excluded as well. No patients had distant or in transit metastasis. Patients were randomly assigned using sealed numbered envelopes to one of two arms of the study in a 1: 1 ratio. In the first group the dissection was conducted with USS (Harmonic Focus ®, Ethicon Endo-Surgery (Europe) GmbH) exclusively. In the control group the lymphadenectomy was performed using ligation and monopolar electrocautery. All patients were operated by a dedicated team headed by a single surgeon.

Monocentric, open, interventional, randomized with two arms 1:1

A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

Duration (days) between surgery and removal of postoperative suction drain

Patients had to record on a list the amount in ml. of lymph in the suction drain bottles

University of Lausanne Hospitals

Professor

Harmonic

Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Switzerland

Region of Enrollment

Prof. Dr Med. Maurice MATTER

Postoperative Draining Time

Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)

Harmonic scalpel

Monopolar scalpel and ligature

Harmonic scalpel

One patient in the Harmonic group was excluded due to insufficient data collection of lymph at home

Daily Amount of Drained Lymph

Overall Study

Gland and Hormone Related Diseases

Postoperative Complications

Thyroid Neoplasms

Thyroid Diseases

Thyroid Nodule

Goiter

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Harmonic Scalpel

Luiz P Kowalski, PhD

Andre L Carvalho

Maria P Curado, PhD

Paola Pedruzzi, MSc

Roberto Araujo Lima, PhD

Fernando Pinto, MD

Carlos Lehn, PhD

Fernando Walder

Jose de Gois Filho, MD

Antonio J Gonçalves, PhD

Harmonic scalpel is a new surgical instrument. Its use has been recommended in patients submitted to total thyroidectomy. Few randomized controlled trials has been published. However they had small sample sizes, used intermediate outcomes and included different surgical procedures.

Our objective is to asses the use of Harmonic scalpel in patients submitted to total thyroidectomy using surgical complications, operative time, drainage volume, postoperative pain, length of stay and costs as outcomes. Our hypothesis is that Harmonic scalpel decreases operative time,drainage volume, postoperative pain, length of stay and costs without increasing surgical complications

This is a multicentric open phase IV randomized controlled trial comparing patients submitted to total thyroidectomy comparing standard surgical procedure versus Harmonic scalpel assisted procedure. Adult patients with benign or malignant thyroid disease and normal function will be included. Patients with giant goiter, hyperthyroidism, non differentiated thyroid carcinoma, locally invasive tumors, neck dissection, previous neck radiotherapy or chemotherapy, video assisted surgery and severe comorbidities will be excluded. calculated sample size was 280 patients. Outcomes will be assessed by an independent monitor. All centers will made a previous standardization of surgical procedures.

Total Thyroidectomy With Harmonic Scalpel®

Total Thyroidectomy With Harmonic Scalpel® Versus Standard Surgery. Open Multicentric Randomized Controlled Trial

Johnson & Johnson

Brazilian Society of Head and Neck Surgery

Digestive System Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips.

Liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (\<3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips.

Hui Chuan Sun, Professor

Jia Fan, Professor

Jian Zhou, Professor

Shuang Jian Qiu, Professor

Guo Ming Shi, Asso. Prof.

Qing Hai Ye, Professor

Lu Wang, Professor

Xiao Wu Huang, Professor

Ning Ren, Professor

Jing Xian Yu, Nurse

Yang Xu, Asso. Prof.

Ying Hong Shi, Asso. Prof.

Xiao Ying Wang, Asso. Prof

Jian Sun, Asso. Prof.

Zheng Wang, Asso. Prof.

Yong Sheng Xiao, Asso. Prof.

Pei Chen, Asso. Prof.

Cheng Huang, Asso. Prof.

Ying Hao Shen, Asso. Prof.

Blood loss during liver resection significantly associates with short term operative outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume centers. Conventional method (crush-clamp) has been a standard technique for liver transection. Technique advances related to liver transection have contributed to reduction in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased operative time, blood loss and transfusion requirement, and an increased incidence of postoperative bile leakage. However, no randomized study has compared the difference between liver resection using traditional technology and harmonic Scalpel. The objective of this prospective randomized study is to compare the safety and efficacy of liver resection using the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay and postoperative complications.

Blood loss during liver resection significantly associates with short term operative outcome. The median blood loss during partial liver resection is 700-1200ml in high-volume centers. Conventional method (crush-clamp) has been a standard technique for liver transection. Technique advances related to liver transection have contributed to reduction in blood loss. Several studies have showed that Harmonic Scalpel in liver resection is safe and easy to use. A nonrandomized study showed use of the Harmonic Scalpel was associated with decreased operative time, blood loss and transfusion requirement, and an increased incidence of postoperative bile leakage. However, no randomized study has compared the difference between liver resection using traditional technology and harmonic Scalpel. The objective of this prospective randomized study is to compare the safety and efficacy of liver resection using the harmonic scalpel device with the "crush-clamp" technique in respect to blood loss, liver transection time, hepatic hilum clamping time, hospital stay and postoperative complications. All patients submitted to liver resection are randomized into two groups: those submitted to liver resection with the use of "crush-clamp" technique. (group Α) and those with the use of the Harmonic Scalpel device (group Β).

Crush-clamping Method (group A) :Patients submitted to liver resection with the use of "crush-clamping" technique.

Device: Liver parenchymal is crushed by surgeon's fingers or basic surgical clamps to isolate small vessels and biliary radicals, and then divided by suture ligation, electrocautery, or vascular clips.

Harmonic Scalpel (group B) :Patients submitted to liver resection with the use of the Harmonic Scalpel device.Device: liver parenchymal transection is transected by harmonic scalpel, and small vessels and biliary radicals (\<3mm) is also divided by harmonic scalpel. Vessels and biliary radicals (≥ 3mm) were divided by suture ligation, electrocautery, or vascular clips.

Primary Outcome Measures:

Blood loss during operation \[an expected average of 3 hours\] operation\]\[Designated as safety issue: Yes\] Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function \[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 8 days\] \[Designated as safety issue: Yes\]

Secondary Outcome Measures:

Transection time from Mark of the cutting edge to finish disposed of the cutting edge \[Designated as safety issue: No\] Hepatic hilar clamping time (Pringle's method) \[the duration of clamping of hepatic hilar\] \[Designated as safety issue: No\] Hospital stay \[participants will be followed for the duration of hospital stay, an expected average of 8 days\] \[Designated as safety issue: No\] Enrollment: 128 Study Start Date: June 2014 Study Completion Date: May 2015 Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Eligibility:

Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

1. Age ≥18y, and ≤80y;
2. No history of liver resection and radiotherapy
3. Liver function: Child A with a normal prothrombin time (\<13 seconds) and international normalized ratio (INR )(\<1.15);
4. Extent of resection ≥2 segment or diameter of tumor (single nodule) ≥ 8cm or cumulative diameter of tumor (multiple nodule) ≥ 8cm; Eligible patients will be stratified by resection in left lobe or right lobe.
5. No tumor thrombosis in main trunk or right and left branch of portal vein or major hepatic vein.

Exclusion Criteria:

1. Recurrent liver tumor; or simultaneous resection of other organs except gallbladder
2. Prothrombin time \> 13seconds;
3. Blood platelets count (BPC) \< 60\*109
4. Moderate and severe of esophageal varices detected by CT or MRI
5. Diameter of portal vein \> 14mm (color ultrasound)

Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method

Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method: A Prospective Randomized Study

Amount of blood loss will be assayed during operation.

Liver transection time from Mark of the cutting edge to finish disposed of the cutting edge will be recorded.

Hepatic hilar clamping time (Pringle's method) will be recorded.

Postoperative complications including bile leakage, bleeding, morbidity, injured Liver function will be recorded.

Hui-Chuan Sun

Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation

electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels.

The Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation

Neck dissection with Harmonic scalpel

electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels

neck dissection with conventional hand-tie ligation

Yoon Woo Koh, MD, PhD

Hyoung Shin Lee, MD

Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.

The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection

The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study

number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection

major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus

hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications

The time from the first procedure after subplatysmal flap elevation to removal of neck dissection specimen will be measured

Estimated blood loss from the collection bottle for the suction drain (ml) will be measured

total amount of drainage is estimated from the collection bottle of closed drain(ml)

amount of drain collected in the drain bottle is estimated daily (ml)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection	NCT02476357	Lymph Node Diss... Lymphoedema Lymphocoele	Harmonic scalpe...	18 Years -	University of Lausanne Hospitals
Total Thyroidectomy With Harmonic Scalpel®	NCT00385983	Thyroid Neoplas... Goiter Thyroid Nodule	Harmonic Scalpe...	18 Years -	Brazilian Society of Head and Neck Surgery
Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method	NCT02213692	Hepatic Neoplas...		18 Years - 80 Years	Fudan University
Comparative Study on Liver Resection Between Harmonic Scalpel Versus Crush-clamping Method	NCT02213692	Hepatic Neoplas...		18 Years - 80 Years	Fudan University
The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection	NCT01488682	Head and Neck C...	Neck dissection... neck dissection...	18 Years - 90 Years	Yonsei University
Total Thyroidectomy With Harmonic Scalpel®	NCT00385983	Thyroid Neoplas... Goiter Thyroid Nodule	Harmonic Scalpe...	18 Years -	Brazilian Society of Head and Neck Surgery

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