Status not kept up to date
Minimally Invasive Right Colectomy Anastomosis Study
NCT03650517 · Instituto de Investigación Marqués de Valdecilla · Updated 25 Sept 2019
- What is being tested
- Extracorporeal Anastomosis; Intracorporeal Anastomosis; Robotic Surgery; Laparoscopic Surgery
- For
- Colorectal Cancer; Anastomotic Complication; Colectomy
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 1,200 people. The full rules are on the registry page.
- Where
- Croatia, Denmark, Finland, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom (32 sites)
- When
- Starts or started 1 Nov 2018, ends 1 Dec 2021. Registered 28 Aug 2018.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- County Hospital PožegaPožega, Croatia
- Hospital of Southern DenmarkAabenraa, Denmark
- Zealand University HospitalKøge, Denmark
- Kanta-Hämeen KeskussairaalaHämeenlinna, Finland
- Kymenlaakso Central HospitalKotka, Finland
- Päijät-Häme Central HospitalLahti, Finland
- Oulu University HospitalOulu, Finland
- Seinäjoki Central HospitalSeinäjoki, Finland
- Hôpital Haut-Lévèque- CHUBordeaux, France
- CHU EstaingClermont-Ferrand, France
- ICM - Institut Régional du Cancer de MontpellierMontpellier, France
- CHRU de Strasbourg Hôpital CivilStrasbourg, France
- CHRU Nancy BraboisVandœuvre-lès-Nancy, France
- Medizinische Hochschule HannoverHanover, Germany
- Eurokliniki AthinouAthens, Athina, Greece
- AOU-CareggiFlorence, Italy
- Ospedale La MisericordiaGrosseto, Italy
- IEO - European Institute of OncologyMilan, Italy
- Policlínico Agostino GemelliRoma, Italy
- Humanitas Research HospitalRozzano, Italy
- IRCCS Istituto di CandioloTorino, Italy
- Centro Hospitalar de LeiriaLeiria, Portugal
- Hospital General Universitario de ElcheElche, Alicante, Spain
- Hospital Universitario DonostiaDonostia / San Sebastian, Basque Country, Spain
- Hospital Universitario Marqués de ValdecillaSantander, Cantabria, Spain
- Hospital Universitario Vall d´hebronBarcelona, Catalonia, Spain
- Hospital Central de AsturiasOviedo, Principality of Asturias, Spain
- Complejo hospitalario de TorrecardenasAlmería, Spain
- Hospital de LeónLeón, Spain
- Hospital Clínico San CarlosMadrid, Spain
And 2 more on the registry page.