Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: Robot-assisted laparoscopic extended right colectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans B Rahr, MD DMSc; Phone Number: +4520574529; Email: hans.rahr@rsyd.dk
• Study Contact Backup: Name: Lars Bundgaard, MD; Phone Number: +4579405618; Email: lars.bundgaard@rsyd.dk

Study Locations

• Denmark
  • Vejle, Denmark, DK7100
    • Recruiting
    • Vejle Hospital, Department of Surgery
    • Contact: Hans B Rahr, MD DMSc; Phone Number: +4520574529; Email: hans.rahr@rsyd.dk
    • Contact: Helle Gangelhof, RN; Phone Number: +4520574530; Email: helle.gangelhof@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic CME; Robot-assisted extended right colectomy	Device: Robot-assisted laparoscopic extended right colectomy; 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; Other Names: DaVinci Xi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plane of dissection	As judged by pathologist (mesocolic/intramesocolic/intramuscular)	30 days
Lymph node count	Number of nodes in specimen, as determined by pathologist	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Postoperative complications, graded by Clavien-Dindo	30 days
Reinterventions	Reinterventions under anesthesia before discharge from hospital	30 days
Length of stay	Days from operation to discharge from hospital	30 days
Readmissions	Readmissions to hospital 1-30 days after initial discharge	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	Minutes from first incision to final stitch	intraoperative
Conversion rate	Percentage of conversions from robotic to open surgery	30 days

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Principal Investigator: Lars Bundgaard, MD, Department of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Robot; Hemicolectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplasms; Colorectal Neoplasms
• Other Study ID Numbers: RobotCME01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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