A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol)

Autor: Jae Seok Min, Hyun-Dong Chae, Chang In Choi, Hua Huang, Han Hong Lee, Sungsoo Park, Oh Jeong, Sung Il Choi, Ye Seob Jee, Ji-Ho Park, Chang Min Lee
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Laparoscopic surgery
Cancer Research
medicine.medical_specialty
Totally laparoscopic distal gastrectomy
medicine.medical_treatment
Cost-Benefit Analysis
Anastomosis
lcsh:RC254-282
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
Randomized controlled trial
Clinical Protocols
law
Surgical oncology
Gastrectomy
Stomach Neoplasms
Republic of Korea
Genetics
Clinical endpoint
Medicine
Humans
Stage (cooking)
Mortality
Laparoscopy
medicine.diagnostic_test
Laparoscopy-assisted distal gastrectomy
business.industry
Cancer
medicine.disease
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Surgery
030104 developmental biology
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
Quality of Life
Morbidity
business
Gastric cancer
Zdroj: BMC Cancer, Vol 19, Iss 1, Pp 1-7 (2019)
BMC Cancer
ISSN: 1471-2407
DOI: 10.1186/s12885-019-5396-8
Popis: KLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer, named as KLASS 07, has been currently prepared in Korea. Patients diagnosed as gastric cancer, with clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the Americal Joint Committee on Cancer System, were randomized to receive either TLDG or LADG. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 gastrectomies and at least 30 gastrectomies annually (regardless of open or laparoscopic surgery for gastric cancer). The patients who are allocated to TLDG group undergo intracorporeal anastomosis and those who are assigned to LADG undergo extracorporeal anastomosis for gastrointestinal reconstruction. Thirty-one surgeons from 26 institutions were engaged in this trial. The primary endpoint is 30-day morbidity, and secondary endpoint is QOL assessed by the questionnaire score. The KLASS 07 trial is the first multi-center RCT to investigate whether there are significant and quantifiable differences between the QOL of TLDG and LADG. The findings from this trial are expected to be the critical clues for designing the detailed procedures during laparoscopic surgery for gastric cancer. The protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).
Databáze: OpenAIRE
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