Effectiveness of Robotic Surgery for Right Colon Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSir Run Run Shaw Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
DaVinci si or xi system
Procedure/SurgeryIn 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 radical resection
Procedure/SurgeryIn 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).
Treatment groups
610 Participants
are divided into 2 treatment groupsGroup A: Robotic surgery for right colon cancerExperimental treatment 1 intervention
Group B: laparoscopic surgery for right colon cancerActive comparator 1 intervention
Trial outcomes
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).
Time frame
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 monthsSecondary outcomes
1
30-day perioperative complications
Perioperative complications were classified according to the Clavien-Dindo system, including intraoperative, short-term and long-term postoperative complications.
Time frame
up to 1 month.2
Overall survival
5-year overall survival rate
Time frame
5-yearLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sir Run Run Shao hospital Status unavailable 310012, Hanzhou, Zhejiang
China
ChinaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sir Run Run Shaw Hospital
Lead sponsor
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: