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
1 other identifier
observational
1,200
10 countries
32
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 25, 2019
September 1, 2019
2.6 years
July 16, 2018
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surgical wound infection
(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.
30 days
Clavien Dindo Complication
Complications according to Clavien Dindo Classification.
30 days
Secondary Outcomes (14)
Overall Survival
2 years
Disease Free Survival (DFS)
2 years
Local Recurrence rate
2 years
Distant metastases rate
2 years
Rate of Unplanned Conversions to open surgery
7 days
- +9 more secondary outcomes
Other Outcomes (4)
Procalcitonine (PCT) days 1, 3 & 5 postoperative
1, 3 and 5 postoperative days
Time to deambulation
30 days
Return to work/activity
30 days and 3 months
- +1 more other outcomes
Study Arms (4)
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.
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.
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.
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.
Interventions
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
Procedure is performed using robotic instruments
Procedure is performed using standard laparoscopic instruments
Eligibility Criteria
Right colon tumor with indication for right colectomy
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
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, 39008, 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
Related Publications (1)
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.
PMID: 32660467DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcos Gómez Ruiz, MD PhD
Hospital Universitario Marqués de Valdecilla, IDIVAL
- STUDY CHAIR
Galo Peralta, MD
Instituto de Investigación Marqués de Valdecilla
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2018
First Posted
August 28, 2018
Study Start
November 1, 2018
Primary Completion
June 1, 2021
Study Completion
December 1, 2021
Last Updated
September 25, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share