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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Device: Robot-assisted laparoscopic extended right colectomy

• Registration Number: NCT04190589
• Lead Sponsor: Vejle Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-09
• Study Start: 2020-05-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic CME	Robot-assisted laparoscopic extended right colectomy	Robot-assisted extended right colectomy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vejle Hospital, Department of Surgery; 🇩🇰 Vejle, Denmark