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Minimally Invasive Right Colectomy Anastomosis Study (MIRCAST)

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ClinicalTrials.gov Identifier: NCT03650517
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Colorectal Cancer Anastomotic Complication Colectomy Procedure: Extracorporeal Anastomosis Procedure: Intracorporeal Anastomosis Procedure: Robotic Surgery Procedure: Laparoscopic 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 Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Group/Cohort Intervention/treatment
Robotic Right Colectomy with ICA

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

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

Robotic Right Colectomy with ECA

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Procedure: Extracorporeal Anastomosis
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Procedure: Robotic Surgery
Procedure is performed using robotic instruments

Laparoscopic Right Colectomy with ICA

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Procedure: Intracorporeal Anastomosis
Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique

Procedure: Laparoscopic Surgery
Procedure is performed using standard laparoscopic instruments

Laparoscopic Right Colectomy with ECA

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Procedure: Extracorporeal Anastomosis
Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Procedure: Laparoscopic Surgery
Procedure is performed using standard laparoscopic instruments




Primary Outcome Measures :
  1. Surgical wound infection [ Time Frame: 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.

  2. Clavien Dindo Complication [ Time Frame: 30 days ]
    Complications according to Clavien Dindo Classification.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 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

  2. Disease Free Survival (DFS) [ Time Frame: 2 years ]
    Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

  3. Local Recurrence rate [ Time Frame: 2 years ]
    Rate of cancer that has recurred at or near the same place as the original (primary) tumor

  4. Distant metastases rate [ Time Frame: 2 years ]
    Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes

  5. Rate of Unplanned Conversions to open surgery [ Time Frame: 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

  6. Operative time (min) [ Time Frame: 7 days ]
    Operative time from skin to skin in minutes

  7. Complete mesocolic excision (CME) [ Time Frame: 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)

  8. Number of Harvested Lymph Nodes [ Time Frame: 30 days ]
    Number of harvested Lymph nodes according to the definitive pathological report.

  9. R0 Resection [ Time Frame: 30 days ]
    Rate of resection without any affected margins during the surgical procedure.

  10. Length of Stay (LOS, days) [ Time Frame: 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.

  11. Ventral hernia (assessed 1& 2 years after the right colectomy) [ Time Frame: 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.

  12. Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 [ Time Frame: 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.

  13. Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 [ Time Frame: 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.

  14. C-Reactive Protein value (CRP) days 1 & 3 postoperative [ Time Frame: 1 and 3 postoperative days. ]
    CRP values on postoperative day 1 and 3.


Other Outcome Measures:
  1. Procalcitonine (PCT) days 1, 3 & 5 postoperative [ Time Frame: 1, 3 and 5 postoperative days ]
    PCT values on postoperative dates 1, 3 and 5

  2. Time to deambulation [ Time Frame: 30 days ]
    Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking)

  3. Return to work/activity [ Time Frame: 30 days and 3 months ]
    o Time to start working/activity at patient´s job again

  4. Pain evaluation [ Time Frame: Postoperative days 1, 3 and 5 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Right colon tumor with indication for right colectomy
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650517


Contacts
Contact: Marcos Gómez Ruiz, MD PhD 0034942202520 ext 73733 marcos.gomez@scsalud.es
Contact: Lucía Lavín Alconero, BSc PhD eclinicos5@idival.org

Locations
Italy
Ospedale La Misericordia Not yet recruiting
Grosseto, Italy
Contact: Paolo Pietro Bianchi, MD PhD         
Spain
Hospital General Universitario de Elche Not yet recruiting
Elche, Alicante, Spain
Contact: Antonio Arroyo Sebastián, MD         
Principal Investigator: Antonio Arroyo Sebastián         
Hospital Central de Asturias Not yet recruiting
Oviedo, Asturias, Spain
Contact: Nuria Truan Alonso         
Principal Investigator: Nuria Truan Alonso         
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Contact: Marcos Gómez Ruiz, MD         
Sub-Investigator: Carmen Cagigas Fernández         
Sub-Investigator: Julio José Del Castillo Diego         
Sub-Investigator: Joaquin Alonso Martín         
Sub-Investigator: Lidia Cristobal Poch         
Sub-Investigator: Manuel Gómez Fleitas         
Principal Investigator: Marcos Gómez Ruiz         
Hospital Universitario Vall d´hebron Not yet recruiting
Barcelona, Cataluña, Spain
Contact: Eloy Espin         
Principal Investigator: Franco Marinello         
Hospital Universitario Donostia Not yet recruiting
San Sebastián, Pais Vasco, Spain
Sub-Investigator: Carlos Placer Galán         
Principal Investigator: José María Enriquez Navascues         
Complejo hospitalario de Torrecardenas Not yet recruiting
Almería, Spain
Contact: Pedro Antonio Sanchez Fuentes, MD         
Sub-Investigator: Angel Reina Duarte         
Sub-Investigator: Francisco Rubio Gil         
Sub-Investigator: Manuel Ferrer Marquez         
Hospital de León Not yet recruiting
León, Spain
Contact: Vicente Simó Fernández         
Principal Investigator: Vicente Simó Fernández         
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain
Contact: Mauricio García Alonso, MD         
Sub-Investigator: Oscar Cano Valderrama         
Principal Investigator: Mauricio García Alonso         
Hospital Universitario 12 de octubre Not yet recruiting
Madrid, Spain
Contact: Eduardo Rubio Gonzalez         
Sub-Investigator: Oscar García Villar         
Sub-Investigator: María Labalde Martinez         
Principal Investigator: Eduardo Rubio Gonzalez         
Sponsors and Collaborators
Instituto de Investigación Marqués de Valdecilla
Investigators
Principal Investigator: Marcos Gómez Ruiz, MD PhD Hospital Universitario Marqués de Valdecilla, IDIVAL
Study Chair: Galo Peralta, MD Instituto de Investigación Marqués de Valdecilla

Responsible Party: Instituto de Investigación Marqués de Valdecilla
ClinicalTrials.gov Identifier: NCT03650517     History of Changes
Other Study ID Numbers: IDIVAL CI18/27
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto de Investigación Marqués de Valdecilla:
Laparoscopic
Robotic
Right colon tumor
Anastomosis
Intracorporeal
Extracorporeal

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases