Clinical trial NCT03650517: Minimally Invasive Right Colectomy Anastomosis Study
Official title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Anastomotic Complication
Colectomy
Keywords: Laparoscopic
Robotic
Right colon tumor
Anastomosis
Intracorporeal
Extracorporeal
Lead sponsor: Instituto de Investigación Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Right colon tumor with indication for right colectomy

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.

Eligibility 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)

Primary outcomes:
measure: Surgical wound infection
timeFrame: 30 days
measure: Clavien Dindo Complication
timeFrame: 30 days
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Disease Free Survival (DFS)
timeFrame: 2 years
measure: Local Recurrence rate
timeFrame: 2 years
measure: Distant metastases rate
timeFrame: 2 years
measure: Rate of Unplanned Conversions to open surgery
timeFrame: 7 days
measure: Operative time (min)
timeFrame: 7 days
measure: Complete mesocolic excision (CME)
timeFrame: 30 days
measure: Number of Harvested Lymph Nodes
timeFrame: 30 days
measure: R0 Resection
timeFrame: 30 days
measure: Length of Stay (LOS, days)
timeFrame: 3 months
measure: Ventral hernia (assessed 1& 2 years after the right colectomy)
timeFrame: 1 and 2 years after the procedure
measure: Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
timeFrame: 3 months and 1 year after the procedure
measure: Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29
timeFrame: 3 months and 1 year after the procedure
measure: C-Reactive Protein value (CRP) days 1 & 3 postoperative
timeFrame: 1 and 3 postoperative days.
Other outcomes:
measure: Procalcitonine (PCT) days 1, 3 & 5 postoperative
timeFrame: 1, 3 and 5 postoperative days
measure: Time to deambulation
timeFrame: 30 days
measure: Return to work/activity
timeFrame: 30 days and 3 months
measure: Pain evaluation
timeFrame: Postoperative days 1, 3 and 5
Locations:
city: Požega
country: Croatia
facility: County Hospital Požega
city: Aabenraa
country: Denmark
facility: Hospital of Southern Denmark
city: Køge
country: Denmark
facility: Zealand University Hospital
city: Hämeenlinna
country: Finland
facility: Kanta-Hämeen Keskussairaala
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Bordeaux
country: France
facility: Hôpital Haut-Lévèque- CHU
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Montpellier
country: France
facility: ICM - Institut Régional du Cancer de Montpellier
city: Strasbourg
country: France
facility: CHRU de Strasbourg Hôpital Civil
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy Brabois
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Athens
country: Greece
facility: Eurokliniki Athinou
state: Athina
city: Florence
country: Italy
facility: AOU-Careggi
city: Grosseto
country: Italy
facility: Ospedale La Misericordia
city: Milan
country: Italy
facility: IEO - European Institute of Oncology
city: Roma
country: Italy
facility: Policlínico Agostino Gemelli
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
city: Torino
country: Italy
facility: IRCCS Istituto di Candiolo
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´hebron
state: Cataluña
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Pais Vasco
city: Almería
country: Spain
facility: Complejo hospitalario de Torrecardenas
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de octubre
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospital NHS Trust
Study officials:
affiliation: Hospital Universitario Marqués de Valdecilla, IDIVAL
name: Marcos Gómez Ruiz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Investigación Marqués de Valdecilla
name: Galo Peralta, MD
role: STUDY_CHAIR
References:
citation: Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gogenur I, Jayne D, Khan JS, Rautio T, Sanchez-Guillen L, Spinoglio G, Ulrich A, Rouanet P. 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. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.