Hybrid RAS study
Recruiting
- Conditions
- colon cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Patients whose age at registration is 18 years or older.
- Patients who are histologically proven to be colon cancer.
- Preoperative diagnosis of curative primary resection.
- Main tumor site is cecum (C), ascending colon (A) , sigmoid colon (S) or rectosigmoid colon (RS) and robotic-surgery with D2 or higher lymph node dissection is pre-planned.
- Clinical stage I to IIIC (T1-4b, N0-2b, M0: TNM Classification) has been diagnosed.
- Patients with General State Performance Status(ECOG) 0 to 1.
- Patients whose functions of the main organs are adequately maintained and judged to be safe for surgery by the doctor in charge of examination with in 28 days prior to the registration.
- Patients who have the judgment to fully understand the research content.
- Patients with written informed consent to participate in this study.
Exclusion Criteria
- Patients planning combined resection of other organs due to infiltration of other organs
- Patients with chemotherapy (systemic anti-cancer drug treatment) and a history of radiation therapy, including treatment for other cancer species.
- Patients who have a history of open surgery.
- Patients who have a history of laparoscopic stomach resection or colectomy.
- Patients planning simultaneous resection of other organs due to double cancer.
- Patients scheduled to anastomosis at more than two sites due to multiple colon cancer.
- Patients with intraperitoneal infection.
- Patients with serious complications.
- Other patients judged inappropriate by the examining physician.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Operating time
- Secondary Outcome Measures
Name Time Method Anastomosis time Anastomosis time (min)
Loss of blood volume loss of blood volume(mL)
Complications during surgery Complications during surgery
Postoperative first flatus The date of postoperative first flatus
Postoperative first bowel movement postoperative first bowel movement
Postoperative diet resumption postoperative diet resumption
White blood cell count 3 days after surgery White blood cell count
CRP 3 days after surgery CRP
Number of dissected lymph nodes Number of dissected lymph nodes
Proximal margin Proximal margin(PM)
Distal margin distal margin(DM)
Assessment of surgeon stress Assessment of surgeon stress(SURG TLX score)
Assessment of surgeon satisfaction Assessment of surgeon satisfaction(VAS score)
Rehospitalization Rehospitalization
Reoperation Reoperation
Postoperative complications Postoperative complications
Disease-free interval/rate Year 3, Year 5 Disease-free interval/rate(Year 3, Year 5)
Overall survival period/rate Year 3, Year 5 overall survival period/rate(Year 3, Year 5)
Cost of surgery Cost of surgery