Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1200 participants
OBSERVATIONAL
2018-11-01
2021-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Intracorporeal Anastomosis
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Robotic Surgery
Procedure is performed using robotic instruments
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.
Extracorporeal Anastomosis
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
Robotic Surgery
Procedure is performed using robotic instruments
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.
Intracorporeal Anastomosis
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Laparoscopic Surgery
Procedure is performed using standard laparoscopic instruments
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.
Extracorporeal Anastomosis
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
Laparoscopic Surgery
Procedure is performed using standard laparoscopic instruments
Interventions
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Extracorporeal Anastomosis
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
Intracorporeal Anastomosis
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Robotic Surgery
Procedure is performed using robotic instruments
Laparoscopic Surgery
Procedure is performed using standard laparoscopic instruments
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Instituto de Investigación Marqués de Valdecilla
OTHER
Responsible Party
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Principal Investigators
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Marcos Gómez Ruiz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Marqués de Valdecilla, IDIVAL
Galo Peralta, MD
Role: STUDY_CHAIR
Instituto de Investigación Marqués de Valdecilla
Locations
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County Hospital Požega
Požega, , Croatia
Hospital of Southern Denmark
Aabenraa, , Denmark
Zealand University Hospital
Køge, , Denmark
Kanta-Hämeen Keskussairaala
Hämeenlinna, , Finland
Kymenlaakso Central Hospital
Kotka, , Finland
Päijät-Häme Central Hospital
Lahti, , Finland
Oulu University Hospital
Oulu, , Finland
Seinäjoki Central Hospital
Seinäjoki, , Finland
Hôpital Haut-Lévèque- CHU
Bordeaux, , France
CHU Estaing
Clermont-Ferrand, , France
ICM - Institut Régional du Cancer de Montpellier
Montpellier, , France
CHRU de Strasbourg Hôpital Civil
Strasbourg, , France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, , France
Medizinische Hochschule Hannover
Hanover, , Germany
Eurokliniki Athinou
Athens, Athina, Greece
AOU-Careggi
Florence, , Italy
Ospedale La Misericordia
Grosseto, , Italy
IEO - European Institute of Oncology
Milan, , Italy
Policlínico Agostino Gemelli
Roma, , Italy
Humanitas Research Hospital
Rozzano, , Italy
IRCCS Istituto di Candiolo
Torino, , Italy
Centro Hospitalar de Leiria
Leiria, , Portugal
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Vall d´hebron
Barcelona, Catalonia, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Complejo hospitalario de Torrecardenas
Almería, , Spain
Hospital de León
León, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de octubre
Madrid, , Spain
Portsmouth Hospital NHS Trust
Portsmouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Arto Turunen
Role: primary
Pälvi Vento
Role: primary
Jyrki Kössi
Role: primary
Tero Rautio
Role: primary
Tarja Pinta
Role: primary
Anne DUBOIS
Role: primary
Philippe ROUANET
Role: primary
Benoit ROMAIN Benoit
Role: primary
Laurent BRESLER
Role: primary
Markus Winny
Role: primary
Thalia Petropoulou
Role: primary
Andrea Coratti
Role: primary
Paolo Pietro Bianchi, MD PhD
Role: primary
Wanda Luisa Petz
Role: primary
Dominico D´Ugo
Role: primary
Antonino Spinelli
Role: primary
Dario RIBERO
Role: primary
Nuno Rama
Role: primary
Antonio Arroyo Sebastián, MD
Role: primary
Marcos Gómez Ruiz, MD
Role: primary
Eloy Espin
Role: primary
Nuria Truan Alonso
Role: primary
Pedro Antonio Sanchez Fuentes, MD
Role: primary
Vicente Simó Fernández
Role: primary
Mauricio García Alonso, MD
Role: primary
Eduardo Rubio Gonzalez
Role: primary
Jim Kahn
Role: primary
References
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Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gogenur I, Jayne D, Khan JS, Rautio T, Sanchez-Guillen L, Spinoglio G, Ulrich A, Rouanet P. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.
Other Identifiers
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IDIVAL CI18/27
Identifier Type: -
Identifier Source: org_study_id
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