| Objective: |
Comparison of the peri-operative complications after robotic assisted and
laparoscopic minimally invasive right colectomy with intracorporeal
anastomosis versus extracorporeal anastomosis.
Identify potential benefits of robotic assisted procedures for right colon
resections. |
| Aim: |
Primary endpoint: Efficacy of the surgical method is defined as a lack of surgical wound complications (infection, hematoma, hernia).
Secondary endpoints for all groups:
-Clavien-Dindo grade IIIb-IV complications at 30 days post op.
-Oncologic results at 2 years (Overall survival, Disease free survival, Local
recurrence, Metastases rate)
-Rate of Unplanned Conversions to open surgery.
-Operative time (min)
-Complete mesocolic excision (CME).
-Number of Harvested Lymph Nodes
-R0 Resection
-Length of Stay (LOS, days)
-Ventral hernia (1 & 2 years after the procedure)
-Quality of life EORTC QLQ-C30 & QLQ-CR29
-SIRS (CRP) days 1 & 3 postoperative. |
| Methods: |
Observational, prospective, parallel cohorts, international, multi-center study.
The total study duration will be approximately 3-4 years. Study enrollment will take
approximately 24 months. The study subjects will have a short-term follow-up at 30 and 3 months post procedure, with long term follow-up at 1 year and 2 years.
At least 1200 subjects will be enrolled in this study (300 per cohort).
Data will be collected at baseline, operative procedure, discharge, 1 month, 3 months, 1 year and 2 years. This section describes all study requirements at each visit. All follow up patient assessments will be done according to standard of care. |
| Reason for International Trial: |
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:
1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA
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. |
