Minimally Invasive Right Colectomy Anastomosis Study

Colorectal Cancer Clinical Trial

— MIRCAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650517
• Other study ID #: IDIVAL CI18/27
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Anastomotic Complication
• Colectomy
• Colorectal Cancer
• Colorectal Neoplasms

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.