NCT03650517: MIRCAST

Minimally Invasive Right Colectomy Anastomosis Study

Status unknown Last updated 25 September 2019

What this trial tests

trial testing Extracorporeal Anastomosis in Colorectal Cancer in 1,200 participants. Status unknown.

Timeline

1 November 2018

Primary endpoint
1 June 2021

1 December 2021

Quick facts

Lead sponsor	Instituto de Investigación Marqués de Valdecilla
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,200
Start date	1 November 2018
Primary completion	1 June 2021
Estimated completion	1 December 2021
Sites	32 locations across Denmark, France, Finland, Italy, Greece, United Kingdom, Germany, Portugal

Drugs / interventions tested

• Extracorporeal Anastomosis
• Intracorporeal Anastomosis
• Robotic Surgery
• Laparoscopic Surgery

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Anastomotic Complication — all drugs for Anastomotic Complication →
• Colectomy — all drugs for Colectomy →

Sponsor

Instituto de Investigación Marqués de Valdecilla — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Anastomotic Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early outcomes from the Minimally Invasive Right Colectomy Anastomosis study (MIRCAST).
   Gómez Ruiz M, Espin-Basany E, Spinelli A, Cagigas Fernández C, et al · · 2023 · cited 33× · PMID 37289913 · DOI 10.1093/bjs/znad077
2. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor.
   Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, et al · · 2020 · cited 5× · PMID 32660467 · DOI 10.1186/s12893-020-00803-x
3. Relationship between anastomotic technique, incisional hernia, and quality of life-the Minimally Invasive Right Colectomy Anastomosis STudy (MIRCAST).
   Gómez Ruiz M, MIRCAST study group (collaborative) . · · 2025 · PMID 41355692 · DOI 10.1093/bjs/znaf250