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Minimally Invasive Right Colectomy Anastomosis Study

NCT03650517 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2019-09-25

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Instituto de Investigación Marqués de Valdecilla

    lead OTHER

Principal Investigators

  • Marcos Gómez Ruiz, MD PhD · Hospital Universitario Marqués de Valdecilla, IDIVAL

  • Galo Peralta, MD · Instituto de Investigación Marqués de Valdecilla

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-06-01
Completion
2021-12-01

Countries

  • Croatia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650517 on ClinicalTrials.gov