Minimally Invasive Right Colectomy Anastomosis Study (MIRCAST)
MIRCAST is an international prospective cohort study endorsed by ESCP.
Background
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, 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.
This prospective multicentre study comparing surgical approach and anastomotic technique will seek to provide further scientific evidence on the best technique for minimally invasive right colectomy.
Study objective
The objective of this study is to prospectively evaluate the postoperative recovery, hospital stay, wound complications, severe complications, and mid-term results (Hernia, recurrence…) of right colectomy, comparing intracorporeal vs extracorporeal anastomosis and comparing laparoscopic vs robotic techniques.
Study design
This study is a prospective, 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:
- Robotic Right Colectomy with ICA
- Robotic Right Colectomy with ECA
- Laparoscopic Right Colectomy with ICA
- Laparoscopic Right Colectomy with ECA
It is not feasible to randomize patients to compare these techniques as doing so would limit the number of centers that could participate. Not all centers in Europe have access to robotic systems and not all surgeons in Europe are trained in intracorporeal anastomosis.
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. A description of the study visits and required study procedures is included in the protocol. Patient assessments will be done according to standard of care.
Visit www.mircast.net for further information
Rectal Surgery Evaluation Trial (RESET)
Background
Rectal cancer is relatively common, with almost 40,000 new cases estimated for 2017 in the US alone. The standard of care for its treatment is total mesorectal excision (TME), the en bloc sharp dissection of the tumor and the mesorectum (the surrounding perirectal lymphatic tissue located within a thin fascial layer) under direct vision. TME has reduced local recurrence rates and improved overall survival. When combined with low anterior resection (LAR), the technique is used to excise tumors in the lower two-thirds of the rectum, a technically challenging surgery due to a narrow pelvis and difficulties in obtaining adequate exposure.
The Rectal Surgery Evaluation Trial will be a prospective, observational, case-matched, four-cohort, multicenter trial designed to study TME with LAR using open laparotomy, laparoscopy, robot-assisted surgery, or transanal surgery in high-surgical-risk patients with mid-to-low, non-metastatic rectal cancer. All surgeries will be performed by surgeons experienced in a technique. Oncologic, morbidity and functional outcomes will be assessed in a composite primary outcome, with success defined as circumferential resection margin ≥1 mm, TME grade III, and minimal postoperative morbidity (absence of Clavien-Dindo grade III-IV complications within 30 days after surgery). Secondary endpoints will include the co-primary endpoints over the long-term (2 years), quality of surgery, quality of life, length of hospital stay, operative time, and rate of unplanned conversions. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.
Study objective
The primary objective of this study is to prospectively evaluate the oncologic, morbidity and functional outcomes for patients with mid- to low rectal cancers following laparotomy, laparoscopy, robotic assisted, or TaTME surgery.
Study design
This study is an observational prospective, international, multi-center, 4-parallel-cohorts study. Sites or surgeons can include patients in any cohort of the study for which they are qualified and in which they have passed the learning curve of 30 procedures.
Four cohorts will be the subject of study:
- Robotic-assisted abdominal LAR/TME
- Laparoscopic abdominal LAR/TME
- Laparotomy LAR/TME
- Transanal LAR/TME
It is not feasible to randomize patients to compare these techniques as not all centers have surgeons expert in all four techniques.Parameters routinely recorded during TME surgery will be collected prospectively. All enrolled subjects will undergo assessments according the standard of care of each site. Data will be collected at the following intervals; pre-operative, operative, discharge, 30 days, 6 months, 1 year, and 2 years post–surgery.