Minimally Invasive Right Colectomy Anastomosis Study (MIRCAST)
A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis
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:
- Robotic Right Colectomy with ICA
- Robotic Right Colectomy with ECA
- Laparoscopic Right Colectomy with ICA
- 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Požega, Croatia
- Recruiting
- County Hospital Požega
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Aabenraa, Denmark
- Active, not recruiting
- Hospital of Southern Denmark
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Køge, Denmark
- Active, not recruiting
- Zealand University Hospital
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Hämeenlinna, Finland
- Not yet recruiting
- Kanta-Hämeen Keskussairaala
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Contact:
- Arto Turunen
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Kotka, Finland
- Recruiting
- Kymenlaakso Central Hospital
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Contact:
- Pälvi Vento
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Lahti, Finland
- Recruiting
- Päijät-Häme Central Hospital
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Contact:
- Jyrki Kössi
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Oulu, Finland
- Recruiting
- Oulu University Hospital
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Contact:
- Tero Rautio
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Seinäjoki, Finland
- Recruiting
- Seinäjoki Central Hospital
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Contact:
- Tarja Pinta
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Bordeaux, France
- Active, not recruiting
- Hôpital Haut-Lévèque- CHU
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Clermont-Ferrand, France
- Not yet recruiting
- Chu Estaing
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Contact:
- Anne DUBOIS
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Montpellier, France
- Recruiting
- ICM - Institut Regional du Cancer de Montpellier
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Contact:
- Philippe ROUANET
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Strasbourg, France
- Not yet recruiting
- CHRU de Strasbourg Hôpital Civil
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Contact:
- Benoit ROMAIN Benoit
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Vandœuvre-lès-Nancy, France
- Not yet recruiting
- CHRU Nancy Brabois
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Contact:
- Laurent BRESLER
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Hannover, Germany
- Not yet recruiting
- Medizinische Hochschule Hannover
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Contact:
- Markus Winny
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Athina
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Athens, Athina, Greece
- Recruiting
- Eurokliniki Athinou
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Contact:
- Thalia Petropoulou
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Florence, Italy
- Not yet recruiting
- AOU-Careggi
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Contact:
- Andrea Coratti
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Grosseto, Italy
- Recruiting
- Ospedale La Misericordia
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Contact:
- Paolo Pietro Bianchi, MD PhD
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Milan, Italy
- Recruiting
- IEO - European Institute of Oncology
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Contact:
- Wanda Luisa Petz
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Roma, Italy
- Recruiting
- Policlinico Agostino Gemelli
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Contact:
- Dominico D´Ugo
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Rozzano, Italy
- Recruiting
- HUMANITAS Research Hospital
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Torino, Italy
- Not yet recruiting
- IRCCS Istituto di Candiolo
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Contact:
- Dario RIBERO
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Leiria, Portugal
- Not yet recruiting
- Centro Hospitalar de Leiria
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Contact:
- Nuno Rama
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Almería, Spain
- Recruiting
- Complejo Hospitalario de Torrecardenas
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Contact:
- Pedro Antonio Sanchez Fuentes, MD
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Sub-Investigator:
- Angel Reina Duarte
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Sub-Investigator:
- Francisco Rubio Gil
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Sub-Investigator:
- Manuel Ferrer Marquez
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León, Spain
- Recruiting
- Hospital de Leon
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Contact:
- Vicente Simó Fernández
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Principal Investigator:
- Vicente Simó Fernández
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Madrid, Spain
- Recruiting
- Hospital Universitario 12 De Octubre
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Contact:
- Eduardo Rubio Gonzalez
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Sub-Investigator:
- Oscar García Villar
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Sub-Investigator:
- María Labalde Martinez
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Principal Investigator:
- Eduardo Rubio Gonzalez
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Madrid, Spain
- Recruiting
- Hospital Clínico San Carlos
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Contact:
- Mauricio García Alonso, MD
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Sub-Investigator:
- Oscar Cano Valderrama
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Principal Investigator:
- Mauricio García Alonso
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Alicante
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Elche, Alicante, Spain
- Recruiting
- Hospital General Universitario de Elche
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Contact:
- Antonio Arroyo Sebastián, MD
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Principal Investigator:
- Antonio Arroyo Sebastián
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Asturias
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Oviedo, Asturias, Spain
- Recruiting
- Hospital Central de Asturias
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Contact:
- Nuria Truan Alonso
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Principal Investigator:
- Nuria Truan Alonso
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Cantabria
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Santander, Cantabria, Spain, 39008
- Recruiting
- Hospital Universitario Marques de Valdecilla
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Contact:
- Marcos Gómez Ruiz, MD
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Sub-Investigator:
- Carmen Cagigas Fernández
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Sub-Investigator:
- Julio José Del Castillo Diego
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Sub-Investigator:
- Joaquin Alonso Martín
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Sub-Investigator:
- Lidia Cristobal Poch
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Sub-Investigator:
- Manuel Gómez Fleitas
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Principal Investigator:
- Marcos Gómez Ruiz
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Cataluña
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Barcelona, Cataluña, Spain
- Recruiting
- Hospital Universitario Vall d´Hebrón
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Contact:
- Eloy ESPIN
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Principal Investigator:
- Franco Marinello
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Pais Vasco
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San Sebastián, Pais Vasco, Spain
- Recruiting
- Hospital Universitario Donostia
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Sub-Investigator:
- Carlos Placer Galán
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Principal Investigator:
- José María Enriquez Navascues
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Portsmouth, United Kingdom
- Not yet recruiting
- Portsmouth Hospital NHS Trust
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Contact:
- Jim Kahn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older.
- Right colon tumor with indication for right colectomy (benign or malignant disease)
- Patient has a life expectancy of at least 12 weeks
- Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
- Patient has signed and dated the Informed consent before patient inclusion in the study
Exclusion Criteria:
- Patient with a comorbid illness or condition that would preclude the use of surgery
- Patients with cT4b tumors
- Patients unwilling to comply with all follow-up study requirements
- Patient undergoing emergency procedures
- Planned colonic surgery along with major concomitant procedures (e.g. liver resections, other intestinal resections)
- Metastatic disease
- Pregnant or suspected pregnancy
- Inflammatory Bowel Disease (Crohn´s Disease or Ulcerative Colitis)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Robotic Right Colectomy with ICA
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. |
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Procedure is performed using robotic instruments
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Robotic Right Colectomy with ECA
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. |
Procedure is performed using robotic instruments
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
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Laparoscopic Right Colectomy with ICA
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. |
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Procedure is performed using standard laparoscopic instruments
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Laparoscopic Right Colectomy with ECA
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.
Procedure is performed using standard laparoscopic instruments
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Surgical wound infection
Time Frame: 30 days
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(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.
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30 days
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Clavien Dindo Complication
Time Frame: 30 days
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Complications according to Clavien Dindo Classification.
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Survival
Time Frame: 2 years
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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
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2 years
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Disease Free Survival (DFS)
Time Frame: 2 years
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Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
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2 years
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Local Recurrence rate
Time Frame: 2 years
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Rate of cancer that has recurred at or near the same place as the original (primary) tumor
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2 years
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Distant metastases rate
Time Frame: 2 years
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Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes
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2 years
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Rate of Unplanned Conversions to open surgery
Time Frame: 7 days
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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
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7 days
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Operative time (min)
Time Frame: 7 days
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Operative time from skin to skin in minutes
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7 days
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Complete mesocolic excision (CME)
Time Frame: 30 days
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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)
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30 days
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Number of Harvested Lymph Nodes
Time Frame: 30 days
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Number of harvested Lymph nodes according to the definitive pathological report.
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30 days
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R0 Resection
Time Frame: 30 days
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Rate of resection without any affected margins during the surgical procedure.
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30 days
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Length of Stay (LOS, days)
Time Frame: 3 months
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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.
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3 months
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Ventral hernia (assessed 1& 2 years after the right colectomy)
Time Frame: 1 and 2 years after the procedure
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Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site.
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1 and 2 years after the procedure
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Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Time Frame: 3 months and 1 year after the procedure
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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.
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3 months and 1 year after the procedure
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Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29
Time Frame: 3 months and 1 year after the procedure
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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.
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3 months and 1 year after the procedure
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C-Reactive Protein value (CRP) days 1 & 3 postoperative
Time Frame: 1 and 3 postoperative days.
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CRP values on postoperative day 1 and 3.
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1 and 3 postoperative days.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Procalcitonine (PCT) days 1, 3 & 5 postoperative
Time Frame: 1, 3 and 5 postoperative days
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PCT values on postoperative dates 1, 3 and 5
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1, 3 and 5 postoperative days
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Time to deambulation
Time Frame: 30 days
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Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking)
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30 days
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Return to work/activity
Time Frame: 30 days and 3 months
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o Time to start working/activity at patient´s job again
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30 days and 3 months
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Pain evaluation
Time Frame: Postoperative days 1, 3 and 5
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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).
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Postoperative days 1, 3 and 5
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Collaborators and Investigators
Investigators
- Principal Investigator: Marcos Gómez Ruiz, MD PhD, Hospital Universitario Marqués de Valdecilla, IDIVAL
- Study Chair: Galo Peralta, MD, Instituto de Investigación Marqués de Valdecilla
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDIVAL CI18/27
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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