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Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Extracorporeal Anastomosis

Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique

Intracorporeal Anastomosis

Procedure is performed using robotic instruments

Robotic Surgery

Procedure is performed using standard laparoscopic instruments

Laparoscopic Surgery

Marcos Gómez Ruiz, MD PhD

Lucía Lavín Alconero, BSc PhD

Arto Turunen

Pälvi Vento

Jyrki Kössi

Tero Rautio

Tarja Pinta

Anne DUBOIS

Philippe ROUANET

Benoit ROMAIN Benoit

Laurent BRESLER

Markus Winny

Thalia Petropoulou

Andrea Coratti

Paolo Pietro Bianchi, MD PhD

Wanda Luisa Petz

Dominico D´Ugo

Antonino Spinelli

Dario RIBERO

Nuno Rama

Antonio Arroyo Sebastián, MD

Antonio Arroyo Sebastián

Nuria Truan Alonso

Marcos Gómez Ruiz, MD

Carmen Cagigas Fernández

Julio José Del Castillo Diego

Joaquin Alonso Martín

Lidia Cristobal Poch

Manuel Gómez Fleitas

Marcos Gómez Ruiz

Eloy Espin

Franco Marinello

Carlos Placer Galán

José María Enriquez Navascues

Pedro Antonio Sanchez Fuentes, MD

Angel Reina Duarte

Francisco Rubio Gil

Manuel Ferrer Marquez

Vicente Simó Fernández

Mauricio García Alonso, MD

Oscar Cano Valderrama

Mauricio García Alonso

Eduardo Rubio Gonzalez

Oscar García Villar

María Labalde Martinez

Jim Kahn

Galo Peralta, MD

Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.

A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.

However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.

MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:

1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA

All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

MIRCAST study is an observational, prospective, parallel cohorts, international, multi-center to compare robotic assisted and laparoscopic minimally invasive right colectomy, and intracorporeal anastomosis versus extracorporeal anastomosis.

The research is coordinated by Marcos Gómez Ruiz MD PhD from Hospital Universitario Marqués de Valdecilla in Santander, Spain; the sponsorship is performed by Fundacion Instituto de Investigación Marqués de Valdecilla (IDIVAL). The European Society of Coloproctology (ESCP) endorses MIRCAST Study and will run a quality audit/independent monitoring of the study.

The objectives of study are to compare of the peri-operative complications after robotic assisted and laparoscopic minimally invasive right colectomy with intracorporeal anastomosis versus extracorporeal anastomosis.

To Identify potential benefits of robotic assisted procedures for right colon resections.

Minimally Invasive Right Colectomy Anastomosis Study

A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

PCT values on postoperative dates 1, 3 and 5

Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking)

o Time to start working/activity at patient´s job again

Visual analogue scale (VAS) scores at postoperative days. Scores will range from 0 to 10 (0 no pain and 10 a pain you would rather prefer to die).

(CDC definition \[Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus.

Complications according to Clavien Dindo Classification.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive

Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Rate of cancer that has recurred at or near the same place as the original (primary) tumor

Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes

When anything apart of the anastomosis had to be done through the laparotomy. If the anastomosis is not completely performed in an intracorporeal approach, the case is considered also converted

Operative time from skin to skin in minutes

Complete Mesocolic Excision is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen (Hohenberger W, Weber K., Matzel K., Papadopoulost T., Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation - technical notes and outcome. Colorectal Disease 11, 354-365 2008. doi:10.1111/j.1463-1318.2008.01735.x)

Number of harvested Lymph nodes according to the definitive pathological report.

Rate of resection without any affected margins during the surgical procedure.

In hospital stay of the patient from the day that they are admitted before surgery to the day that they are fit to leave the hospital after the procedure.

Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site.

Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure.

Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Score 3 months and 1 year after the procedure.

Spots Global Cancer Trial Database for right colon tumor