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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Laparoscopic Right Colectomy with ECA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Anastomosis | Procedure | Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.](streamdown:incomplete-link) | 30 days |
| Clavien Dindo Complication | Complications according to Clavien Dindo Classification. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disease Free Survival (DFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Procalcitonine (PCT) days 1, 3 & 5 postoperative | PCT values on postoperative dates 1, 3 and 5 | 1, 3 and 5 postoperative days |
| Time to deambulation | Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking) |
Inclusion Criteria:
Exclusion Criteria:
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Right colon tumor with indication for right colectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcos Gómez Ruiz, MD PhD | Contact | 0034942202520 | 73733 | marcos.gomez@scsalud.es |
| Lucía Lavín Alconero, BSc PhD | Contact | eclinicos5@idival.org |
| Name | Affiliation | Role |
|---|---|---|
| Marcos Gómez Ruiz, MD PhD | Hospital Universitario Marqués de Valdecilla, IDIVAL | Principal Investigator |
| Galo Peralta, MD | Instituto de Investigación Marqués de Valdecilla | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| County Hospital Požega | Recruiting | Požega | Croatia | |||
| Hospital of Southern Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32660467 | Derived | 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. |
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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.
|
| Intracorporeal Anastomosis | Procedure | Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique |
|
| Robotic Surgery | Procedure | Procedure is performed using robotic instruments |
|
| Laparoscopic Surgery | Procedure | Procedure is performed using standard laparoscopic instruments |
|
Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.
| 2 years |
| Local Recurrence rate | Rate of cancer that has recurred at or near the same place as the original (primary) tumor | 2 years |
| Distant metastases rate | Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes | 2 years |
| 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 |
| Operative time (min) | Operative time from skin to skin in minutes | 7 days |
| 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 |
| Number of Harvested Lymph Nodes | Number of harvested Lymph nodes according to the definitive pathological report. | 30 days |
| R0 Resection | Rate of resection without any affected margins during the surgical procedure. | 30 days |
| 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 |
| 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 |
| 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 |
| 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 |
| C-Reactive Protein value (CRP) days 1 & 3 postoperative | CRP values on postoperative day 1 and 3. | 1 and 3 postoperative days. |
| 30 days |
| Return to work/activity | o Time to start working/activity at patient´s job again | 30 days and 3 months |
| 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 |
| Active, not recruiting |
| Aabenraa |
| Denmark |
| Zealand University Hospital | Active, not recruiting | Køge | Denmark |
| Kanta-Hämeen Keskussairaala | Not yet recruiting | Hämeenlinna | Finland |
|
| Kymenlaakso Central Hospital | Recruiting | Kotka | Finland |
|
| Päijät-Häme Central Hospital | Recruiting | Lahti | Finland |
|
| Oulu University Hospital | Recruiting | Oulu | Finland |
|
| Seinäjoki Central Hospital | Recruiting | Seinäjoki | Finland |
|
| Hôpital Haut-Lévèque- CHU | Active, not recruiting | Bordeaux | France |
| CHU Estaing | Not yet recruiting | Clermont-Ferrand | France |
|
| ICM - Institut Régional du Cancer de Montpellier | Recruiting | Montpellier | France |
|
| CHRU de Strasbourg Hôpital Civil | Not yet recruiting | Strasbourg | France |
|
| CHRU Nancy Brabois | Not yet recruiting | Vandœuvre-lès-Nancy | France |
|
| Medizinische Hochschule Hannover | Not yet recruiting | Hanover | Germany |
|
| Eurokliniki Athinou | Recruiting | Athens | Athina | Greece |
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| AOU-Careggi | Not yet recruiting | Florence | Italy |
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| Ospedale La Misericordia | Recruiting | Grosseto | Italy |
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| IEO - European Institute of Oncology | Recruiting | Milan | Italy |
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| Policlínico Agostino Gemelli | Recruiting | Roma | Italy |
|
| Humanitas Research Hospital | Recruiting | Rozzano | Italy |
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| IRCCS Istituto di Candiolo | Not yet recruiting | Torino | Italy |
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| Centro Hospitalar de Leiria | Not yet recruiting | Leiria | Portugal |
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| Hospital General Universitario de Elche | Recruiting | Elche | Alicante | Spain |
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| Hospital Universitario Donostia | Recruiting | Donostia / San Sebastian | Basque Country | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
|
| Hospital Universitario Vall d´hebron | Recruiting | Barcelona | Catalonia | Spain |
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| Hospital Central de Asturias | Recruiting | Oviedo | Principality of Asturias | Spain |
|
| Complejo hospitalario de Torrecardenas | Recruiting | Almería | Spain |
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| Hospital de León | Recruiting | León | Spain |
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| Hospital Clínico San Carlos | Recruiting | Madrid | Spain |
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| Hospital Universitario 12 de octubre | Recruiting | Madrid | Spain |
|
| Portsmouth Hospital NHS Trust | Not yet recruiting | Portsmouth | United Kingdom |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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