Effectiveness of Robotic Surgery for Right Colon Cancer

NCT06421974 | Not Yet Recruiting DMC

• 1 other identifier: SRRS-ERSRCC
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis.

Conditions

Colon Cancer; Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival rate

  The time from randomization to first tumor recurrence/metastasis or death from any cause was defined as the time of last follow-up for patients lost to follow-up(Patients still alive at the end of the study, the end of follow-up).

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (2)

• 30-day perioperative complications

  up to 1 month.

• Overall survival

  5-year

Study Arms (2)

Robotic surgery for right colon cancer

EXPERIMENTAL

Robot-assisted right colon cancer radical resection group, referred to as robotic surgery group

Procedure: DaVinci si or xi system

laparoscopic surgery for right colon cancer

ACTIVE COMPARATOR

Laparoscopic right colon cancer radical resection group, referred to as laparoscopic surgery group

Procedure: laparoscopic radical resection

Interventions

DaVinci si or xi system PROCEDURE

In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).

Robotic surgery for right colon cancer

laparoscopic radical resection PROCEDURE

In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).

laparoscopic surgery for right colon cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old.
• ASA classification ≤ Level III.
• Colon adenocarcinoma was confirmed by colonoscopy and biopsy pathology.
• Transabdominal enhanced CT showed that the distal and proximal ends of the primary tumor were located in the right colon (cecum to the proximal 1/3 of the transverse colon).
• Preoperative clinical stage: TanyNanyM0.
• The patient's condition meets the indications for robotic surgery and is willing to accept the robotic surgery treatment plan.
• Voluntarily participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his or her guardian must be responsible for the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.

You may not qualify if:

• Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring intestinal segmental resection.
• The results of preoperative imaging examination or intraoperative exploration suggest: 1) The tumor involves surrounding organs and requires combined organ resection; 2) There is distant metastasis; 3) R0 resection cannot be performed.
• Additional radical surgery after emr and esd surgery.
• Have a history of any other malignant tumor or familial adenomatous polyposis in the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma or cutaneous squamous cell carcinoma.
• Combined intestinal obstruction, intestinal perforation, intestinal bleeding, etc. require emergency surgery.
• Patients who are not suitable for or cannot tolerate robotic or laparoscopic surgery.
• Pregnant or lactating women.
• Patients with a history of mental illness.
• Patients who have received neoadjuvant treatment before surgery.
• MDT discusses patients who are not suitable for entering the study.
• Patients who refuse to undergo either robotic or laparoscopic surgery.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Zhejiang University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Zhejiang Cancer Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo No. 1 Hospital: collaborator

Study Sites (1)

Sir Run Run Shao hospital

Hanzhou, Zhejiang, 310012, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)