Minimally Invasive Right Colectomy Anastomosis Study

• Conditions: Anastomotic Complication; Colectomy; Colorectal Cancer

• Registration Number: NCT03650517
• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-08-26
• Study First Posted: 2018-08-28
• Study Start: 2018-11-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical wound infection	30 days	(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.
Clavien Dindo Complication	30 days	Complications according to Clavien Dindo Classification.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years	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
Disease Free Survival (DFS)	2 years	Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
Local Recurrence rate	2 years	Rate of cancer that has recurred at or near the same place as the original (primary) tumor
Distant metastases rate	2 years	Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes
Number of Harvested Lymph Nodes	30 days	Number of harvested Lymph nodes according to the definitive pathological report.
R0 Resection	30 days	Rate of resection without any affected margins during the surgical procedure.
Length of Stay (LOS, days)	3 months	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.
Ventral hernia (assessed 1& 2 years after the right colectomy)	1 and 2 years after the procedure	Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site.
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	3 months and 1 year after the procedure	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.
Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29	3 months and 1 year after the procedure	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.
C-Reactive Protein value (CRP) days 1 & 3 postoperative	1 and 3 postoperative days.	CRP values on postoperative day 1 and 3.
Rate of Unplanned Conversions to open surgery	7 days	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
Operative time (min)	7 days	Operative time from skin to skin in minutes
Complete mesocolic excision (CME)	30 days	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)

Trial Locations

Locations (32)

County Hospital Požega; 🇭🇷 Požega, Croatia

Hospital of Southern Denmark; 🇩🇰 Aabenraa, Denmark

Zealand University Hospital; 🇩🇰 Køge, Denmark

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, Finland

Hôpital Haut-Lévèque- CHU; 🇫🇷 Bordeaux, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

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