臨床研究等提出・公開システム

Randomized controlled trial to evaluate the efficacy of hybrid robot-assisted surgery using a laparoscopic device in robotic-assisted colorectal cancer surgery

Hybrid RAS study

Watanabe Jun

Kansai Medical University Hospital

Shinmachi 2-5-1, Hirakata ,Osaka

watanabj@hirakata.kmu.ac.jp

Suwa Yusuke

Yokohama City University Medical Center

Urafunecho 4-57, Minami-ku, Yokohama ,Kanagawa

+81-45-261-5656

ysuwa@yokohama-cu.ac.jp

Recruiting

Dec. 13, 2024

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

1. Patients whose age at registration is 18 years or older.
2. Patients who are histologically proven to be colon cancer.
3. Preoperative diagnosis of curative primary resection.
4. 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.
5. Clinical stage I to IIIC (T1-4b, N0-2b, M0: TNM Classification) has been diagnosed.
6. Patients with General State Performance Status(ECOG) 0 to 1.
7. 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.
8. Patients who have the judgment to fully understand the research content.
9. Patients with written informed consent to participate in this study.

1. Patients planning combined resection of other organs due to infiltration of other organs
2. Patients with chemotherapy (systemic anti-cancer drug treatment) and a history of radiation therapy, including treatment for other cancer species.
3. Patients who have a history of open surgery.
4. Patients who have a history of laparoscopic stomach resection or colectomy.
5. Patients planning simultaneous resection of other organs due to double cancer.
6. Patients scheduled to anastomosis at more than two sites due to multiple colon cancer.
7. Patients with intraperitoneal infection.
8. Patients with serious complications.
9. Other patients judged inappropriate by the examining physician.

Both

colon cancer

Hybrid robotic surgery

Operating time

Anastomosis time (min)
loss of blood volume(mL)
Complications during surgery
The date of postoperative first flatus, postoperative first bowel movement, and postoperative diet resumption
White blood cell count, CRP (3 days after surgery)
Number of dissected lymph nodes
Proximal margin(PM) and distal margin(DM)
Assessment of surgeon stress(SURG TLX score)
Assessment of surgeon satisfaction(VAS score)
Rehospitalization, Reoperation
Postoperative complications
Disease-free interval/rate(Year 3, Year 5), overall survival period/rate(Year 3, Year 5)
Cost of surgery

+81-6-6692-1201

Nov. 08, 2024

Yes

none