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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04190589
• Other study ID #: RobotCME01
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Vejle Hospital
• Contact: Hans B Rahr, MD DMSc
• Phone: +4520574529
• Email: hans.rahr[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Vejle Hospital, Department of Surgery	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operation time	Minutes from first incision to final stitch	intraoperative
Other	Conversion rate	Percentage of conversions from robotic to open surgery	30 days
Primary	Plane of dissection	As judged by pathologist (mesocolic/intramesocolic/intramuscular)	30 days
Primary	Lymph node count	Number of nodes in specimen, as determined by pathologist	30 days
Secondary	Complications	Postoperative complications, graded by Clavien-Dindo	30 days
Secondary	Reinterventions	Reinterventions under anesthesia before discharge from hospital	30 days
Secondary	Length of stay	Days from operation to discharge from hospital	30 days
Secondary	Readmissions	Readmissions to hospital 1-30 days after initial discharge	30 days