MedPath

Hybrid RAS study

Recruiting
Conditions
colon cancer
Registration Number
jRCTs052240215
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
120
Inclusion Criteria
  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.
Exclusion Criteria
  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.

Study & Design

Study Type
Interventional
Study Design
parallel assignment
Primary Outcome Measures
NameTimeMethod
-

Operating time

Secondary Outcome Measures
NameTimeMethod
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 count3 days after surgery

White blood cell count

CRP3 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/rateYear 3, Year 5

Disease-free interval/rate(Year 3, Year 5)

Overall survival period/rateYear 3, Year 5

overall survival period/rate(Year 3, Year 5)

Cost of surgery

Cost of surgery

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