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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03650517
Other study ID # IDIVAL CI18/27
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date December 1, 2021

Study information

Verified date September 2019
Source Instituto de Investigación Marqués de Valdecilla
Contact Marcos Gómez Ruiz, MD PhD
Phone 0034942202520
Email marcos.gomez@scsalud.es
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date December 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

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

Locations

Country Name City State
Croatia County Hospital Požega Požega
Denmark Hospital of Southern Denmark Aabenraa
Denmark Zealand University Hospital Køge
Finland Kanta-Hämeen Keskussairaala Hämeenlinna
Finland Kymenlaakso Central Hospital Kotka
Finland Päijät-Häme Central Hospital Lahti
Finland Oulu University Hospital Oulu
Finland Seinäjoki Central Hospital Seinäjoki
France Hôpital Haut-Lévèque- CHU Bordeaux
France CHU Estaing Clermont-Ferrand
France ICM - Institut Régional du Cancer de Montpellier Montpellier
France CHRU de Strasbourg Hôpital Civil Strasbourg
France CHRU Nancy Brabois Vandœuvre-lès-Nancy
Germany Medizinische Hochschule Hannover Hannover
Greece Eurokliniki Athinou Athens Athina
Italy AOU-Careggi Florence
Italy Ospedale La Misericordia Grosseto
Italy IEO - European Institute of Oncology Milan
Italy Policlínico Agostino Gemelli Roma
Italy Humanitas Research Hospital Rozzano
Italy IRCCS Istituto di Candiolo Torino
Portugal Centro Hospitalar de Leiria Leiria
Spain Complejo hospitalario de Torrecardenas Almería
Spain Hospital Universitario Vall d´hebron Barcelona Cataluña
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital de León León
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario 12 de octubre Madrid
Spain Hospital Central de Asturias Oviedo Asturias
Spain Hospital Universitario Donostia San Sebastián Pais Vasco
Spain Hospital Universitario Marqués de Valdecilla Santander Cantabria
United Kingdom Portsmouth Hospital NHS Trust Portsmouth

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Investigación Marqués de Valdecilla

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Other Procalcitonine (PCT) days 1, 3 & 5 postoperative PCT values on postoperative dates 1, 3 and 5 1, 3 and 5 postoperative days
Other Time to deambulation Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking) 30 days
Other Return to work/activity o Time to start working/activity at patient´s job again 30 days and 3 months
Other Pain evaluation Visual analogue scale (VAS) scores at postoperative days. Scores will range from 0 to 10 (0 no pain and 10 a pain you would rather prefer to die). Postoperative days 1, 3 and 5
Primary Surgical wound infection (CDC definition [Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. 30 days
Primary Clavien Dindo Complication Complications according to Clavien Dindo Classification. 30 days
Secondary Overall Survival The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive 2 years
Secondary Disease Free Survival (DFS) Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. 2 years
Secondary Local Recurrence rate Rate of cancer that has recurred at or near the same place as the original (primary) tumor 2 years
Secondary Distant metastases rate Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes 2 years
Secondary Rate of Unplanned Conversions to open surgery When anything apart of the anastomosis had to be done through the laparotomy. If the anastomosis is not completely performed in an intracorporeal approach, the case is considered also converted 7 days
Secondary Operative time (min) Operative time from skin to skin in minutes 7 days
Secondary Complete mesocolic excision (CME) Complete Mesocolic Excision is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen (Hohenberger W, Weber K., Matzel K., Papadopoulost T., Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation - technical notes and outcome. Colorectal Disease 11, 354-365 2008. doi:10.1111/j.1463-1318.2008.01735.x) 30 days
Secondary Number of Harvested Lymph Nodes Number of harvested Lymph nodes according to the definitive pathological report. 30 days
Secondary R0 Resection Rate of resection without any affected margins during the surgical procedure. 30 days
Secondary Length of Stay (LOS, days) In hospital stay of the patient from the day that they are admitted before surgery to the day that they are fit to leave the hospital after the procedure. 3 months
Secondary Ventral hernia (assessed 1& 2 years after the right colectomy) Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site. 1 and 2 years after the procedure
Secondary Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure. 3 months and 1 year after the procedure
Secondary Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Score 3 months and 1 year after the procedure. 3 months and 1 year after the procedure
Secondary C-Reactive Protein value (CRP) days 1 & 3 postoperative CRP values on postoperative day 1 and 3. 1 and 3 postoperative days.
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