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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Robot-assisted laparoscopic extended right colectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single-arm study with historical controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic CME<br>Robot-assisted extended right colectomy | Device: Robot-assisted laparoscopic extended right colectomy<br>* 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<br>* Other names: DaVinci Xi;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot, Hemicolectomy, Cancer