Colorectal Cancer Clinical Trial
Official title:
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:
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.
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