Clinical trial NCT01179750: The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Official title: The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stomach Cancer
Gastrectomy
Ultrasonic Coagulating Shears
Keywords: Ultrasonic coagulating shears in gastrectomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 256
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .

In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.

The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.

The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.


Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of gastric cancer
* The patient who agrees to participate in this study by signing the informed consent form

Exclusion Criteria:

* The patient who refuse to participate in this study
* Have simultaneously other cancer
* Underwent cancer therapy at past time
* Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
* Have a previous upper gastrointestinal surgery

Primary outcomes:
measure: operation time
timeFrame: 2 weeks later after operation
measure: amount of blood loss
timeFrame: 2 weeks later after operation
Secondary outcomes:
measure: C-reactive protein
timeFrame: post operative day #0, #1, #5
measure: total lymphocyte count
timeFrame: post operative day #0, #1, #5
measure: postoperative complications
timeFrame: 4 weeks later after operation
measure: drainage from peritoneal cavity during hospital
timeFrame: 2 weeks later after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University
name: Jae Moon Bae, MD., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002 Feb;26(2):158-61. doi: 10.1007/s00268-001-0199-9. Epub 2001 Dec 4.