Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Robot-assisted laparoscopic extended right colectomy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Robot, Hemicolectomy, Cancer
Eligibility Criteria
Inclusion Criteria:
- Suspected or verified colonic cancer visualized by colonoscopy and on CT in the anal part of the ascending colon, in the right flexure or in the oral 2/3 of the transverse colon
- Patient is 18 years or older, legally competent and able to comprehend information and give consent
- Tumor is UICC stage I-III on preop CT
- Operation is elective
Exclusion Criteria:
- Previous major open intraabdominal surgery
- Ileus or other acute abdominal condition
- CT scan with suspicion of T4 tumor
- RITA score > 3 (Preop risk and frailty score)
- BMI > 35 kg/m2
- Project surgeon not available
Sites / Locations
- Vejle Hospital, Department of SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic CME
Arm Description
Robot-assisted extended right colectomy
Outcomes
Primary Outcome Measures
Plane of dissection
As judged by pathologist (mesocolic/intramesocolic/intramuscular)
Lymph node count
Number of nodes in specimen, as determined by pathologist
Secondary Outcome Measures
Complications
Postoperative complications, graded by Clavien-Dindo
Reinterventions
Reinterventions under anesthesia before discharge from hospital
Length of stay
Days from operation to discharge from hospital
Readmissions
Readmissions to hospital 1-30 days after initial discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04190589
Brief Title
Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer
Official Title
A Single Center Prospective Study Comparing Robot-assisted and Open Operation With Complete Mesocolic Excision (CME) in Extended Right Colectomy for Colon Cancer in the Right Flexure and Transverse Colon
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single-center prospective study to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.
Detailed Description
Complete mesocolic excision with central vascular ligation (CME) is an improvement of surgical technique in the operation for colonic cancer suggested to increase long-term survival. The concept was originally developed for open surgery by W. Hohenberger in Erlangen with excellent survival rates. However, if the tumor is located in the transverse colon or near the right colonic flexure, the procedure is particularly technically demanding, and for that reason most surgeons still prefer to do it by open operation (laparotomy) instead of the minimally invasive approach (laparoscopy) presently recommended for colonic cancer surgery. The advent of robotic surgery has improved the dexterity of instruments used in laparoscopic surgery and pushed the limits of what is possible with a minimally invasive approach. Since minimally invasive surgery is associated with better outcomes in terms of postoperative morbidity, pain, length of stay etc., it would be highly desirable if CME surgery could be done by robot-assisted laparoscopic operation instead of the current open approach. The current single-center study is proposed to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Robot, Hemicolectomy, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective single-arm study with historical controls
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robotic CME
Arm Type
Experimental
Arm Description
Robot-assisted extended right colectomy
Intervention Type
Device
Intervention Name(s)
Robot-assisted laparoscopic extended right colectomy
Other Intervention Name(s)
DaVinci Xi
Intervention Description
An extended right hemicolectomy with total mesocolic excision and meticulous central dissection as described by Hohenberger will be performed with the DaVinci Xi robot by one of two dedicated surgeons
Primary Outcome Measure Information:
Title
Plane of dissection
Description
As judged by pathologist (mesocolic/intramesocolic/intramuscular)
Time Frame
30 days
Title
Lymph node count
Description
Number of nodes in specimen, as determined by pathologist
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Complications
Description
Postoperative complications, graded by Clavien-Dindo
Time Frame
30 days
Title
Reinterventions
Description
Reinterventions under anesthesia before discharge from hospital
Time Frame
30 days
Title
Length of stay
Description
Days from operation to discharge from hospital
Time Frame
30 days
Title
Readmissions
Description
Readmissions to hospital 1-30 days after initial discharge
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Operation time
Description
Minutes from first incision to final stitch
Time Frame
intraoperative
Title
Conversion rate
Description
Percentage of conversions from robotic to open surgery
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected or verified colonic cancer visualized by colonoscopy and on CT in the anal part of the ascending colon, in the right flexure or in the oral 2/3 of the transverse colon
Patient is 18 years or older, legally competent and able to comprehend information and give consent
Tumor is UICC stage I-III on preop CT
Operation is elective
Exclusion Criteria:
Previous major open intraabdominal surgery
Ileus or other acute abdominal condition
CT scan with suspicion of T4 tumor
RITA score > 3 (Preop risk and frailty score)
BMI > 35 kg/m2
Project surgeon not available
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans B Rahr, MD DMSc
Phone
+4520574529
Email
hans.rahr@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Bundgaard, MD
Phone
+4579405618
Email
lars.bundgaard@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Bundgaard, MD
Organizational Affiliation
Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vejle Hospital, Department of Surgery
City
Vejle
ZIP/Postal Code
DK7100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans B Rahr, MD DMSc
Phone
+4520574529
Email
hans.rahr@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Helle Gangelhof, RN
Phone
+4520574530
Email
helle.gangelhof@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer
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