Minimally Invasive Right Colectomy Anastomosis Study (MIRCAST)

Instituto de Investigación Marqués de Valdecilla

Status: Unknown

Conditions: Anastomotic Complication; Colectomy; Colorectal Cancer

Treatments: Procedure: Laparoscopic Surgery; Procedure: Robotic Surgery; Procedure: Intracorporeal Anastomosis; Procedure: Extracorporeal Anastomosis

Study type: Observational

Funder types: Other

Identifiers

NCT03650517

IDIVAL CI18/27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Scale score of ≤2)
• Patient has signed and dated the Informed consent before patient inclusion in the study

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. liver resections, other intestinal resections)
• Metastatic disease
• Pregnant or suspected pregnancy
• Inflammatory Bowel Disease (Crohn´s Disease or Ulcerative Colitis)

Trial design

1,200 participants in 4 patient groups

Robotic Right Colectomy with ICA

Description:

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.

Treatment:

Procedure: Intracorporeal Anastomosis

Procedure: Robotic Surgery

Robotic Right Colectomy with ECA

Description:

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.

Treatment:

Procedure: Extracorporeal Anastomosis

Procedure: Robotic Surgery

Laparoscopic Right Colectomy with ICA

Description:

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.

Treatment:

Procedure: Intracorporeal Anastomosis

Procedure: Laparoscopic Surgery

Laparoscopic Right Colectomy with ECA

Description:

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.

Treatment:

Procedure: Extracorporeal Anastomosis

Procedure: Laparoscopic Surgery