NCT03650517

Minimally Invasive Right Colectomy Anastomosis Study

A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colorectal Cancer
• Anastomotic Complication
• Colectomy

Interventions

Type	Name	Description
PROCEDURE	Extracorporeal Anastomosis	Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
PROCEDURE	Intracorporeal Anastomosis	Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
PROCEDURE	Robotic Surgery	Procedure is performed using robotic instruments
PROCEDURE	Laparoscopic Surgery	Procedure is performed using standard laparoscopic instruments

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2018-08-28
• Last updated: 2019-09-25

Locations

32 sites across 10 countries: Croatia, Denmark, Finland, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom