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

NCT04190589 | Recruiting FDA Device

• 1 other identifier: RobotCME01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Robot; Hemicolectomy; Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Complications

  30 days

• Reinterventions

  30 days

• Length of stay

  30 days

• Readmissions

  30 days

Other Outcomes (2)

• Operation time

  intraoperative

• Conversion rate

  30 days

Study Arms (1)

Robotic CME

EXPERIMENTAL

Robot-assisted extended right colectomy

Device: Robot-assisted laparoscopic extended right colectomy

Interventions

Robot-assisted laparoscopic extended right colectomy DEVICE

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

Also known as: DaVinci Xi

Robotic CME

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital, Department of Surgery

Vejle, DK7100, Denmark

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lars Bundgaard, MD

  Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans B Rahr, MD DMSc

CONTACT

+4520574529; hans.rahr@rsyd.dk

Lars Bundgaard, MD

CONTACT

+4579405618; lars.bundgaard@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-arm study with historical controls

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 9, 2019
• Study Start: May 18, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)