Minimally Invasive Right Colectomy Anastomosis Study

Last updated: September 24, 2019
Sponsor: Instituto de Investigación Marqués de Valdecilla
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT03650517
IDIVAL CI18/27
  • Ages > 18
  • All Genders

Study 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

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.

Eligibility Criteria

Inclusion

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 Scalescore of ≤2)

  • Patient has signed and dated the Informed consent before patient inclusion in thestudy

Exclusion

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. liverresections, other intestinal resections)

  • Metastatic disease

  • Pregnant or suspected pregnancy

  • Inflammatory Bowel Disease (Crohn´s Disease or Ulcerative Colitis)

Study Design

Total Participants: 1200
Study Start date:
November 01, 2018
Estimated Completion Date:
December 01, 2021

Study 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.

Connect with a study center

  • County Hospital Požega

    Požega,
    Croatia

    Active - Recruiting

  • Hospital of Southern Denmark

    Aabenraa,
    Denmark

    Site Not Available

  • Zealand University Hospital

    Køge,
    Denmark

    Site Not Available

  • Kanta-Hämeen Keskussairaala

    Hämeenlinna,
    Finland

    Site Not Available

  • Kymenlaakso Central Hospital

    Kotka,
    Finland

    Active - Recruiting

  • Päijät-Häme Central Hospital

    Lahti,
    Finland

    Active - Recruiting

  • Oulu University Hospital

    Oulu,
    Finland

    Active - Recruiting

  • Seinäjoki Central Hospital

    Seinäjoki,
    Finland

    Active - Recruiting

  • Hôpital Haut-Lévèque- CHU

    Bordeaux,
    France

    Site Not Available

  • CHU Estaing

    Clermont-Ferrand,
    France

    Site Not Available

  • ICM - Institut Régional du Cancer de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHRU de Strasbourg Hôpital Civil

    Strasbourg,
    France

    Site Not Available

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy,
    France

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Eurokliniki Athinou

    Athens, Athina
    Greece

    Active - Recruiting

  • AOU-Careggi

    Florence,
    Italy

    Site Not Available

  • Ospedale La Misericordia

    Grosseto,
    Italy

    Active - Recruiting

  • IEO - European Institute of Oncology

    Milan,
    Italy

    Active - Recruiting

  • Policlínico Agostino Gemelli

    Roma,
    Italy

    Active - Recruiting

  • Humanitas Research Hospital

    Rozzano,
    Italy

    Active - Recruiting

  • IRCCS Istituto di Candiolo

    Torino,
    Italy

    Site Not Available

  • Centro Hospitalar de Leiria

    Leiria,
    Portugal

    Site Not Available

  • Hospital General Universitario de Elche

    Elche, Alicante
    Spain

    Active - Recruiting

  • Hospital Central de Asturias

    Oviedo, Asturias
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d´hebron

    Barcelona, Cataluña
    Spain

    Active - Recruiting

  • Hospital Universitario Donostia

    San Sebastián, Pais Vasco
    Spain

    Active - Recruiting

  • Complejo hospitalario de Torrecardenas

    Almería,
    Spain

    Active - Recruiting

  • Hospital de León

    León,
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de octubre

    Madrid,
    Spain

    Active - Recruiting

  • Portsmouth Hospital NHS Trust

    Portsmouth,
    United Kingdom

    Site Not Available

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