The Hugo RAS Colorectal Collaborative (HRCC) is an international, multicenter dataset of patients undergoing colorectal surgery using the Hugo RAS system. The registry aims to analyze short and long-term outcomes to provide real-world evidence on the safety and effectiveness of the system.
This prospective observational study will gather data via standardized electronic Case Report Forms (eCRFs) across multiple international high-volume colorectal surgery centers. The study intends to foster the standardization of surgical techniques, evaluate the learning curve of surgeons, and identify surgical best practices for the Hugo RAS modular system. The total expected duration for the initial phase is approximately 3 years, followed by extended long-term follow-up.
Study Type
OBSERVATIONAL
Enrollment
2,000
Complications
Number of participants experiencing intraoperative complications, which will include the recording of robotic arm conflicts, system alarms (including red alarms), and any technical difficulties encountered.
Time frame: Intraoperatively
Rate of Postoperative Complications
Number and severity of postoperative complications assessed using the Clavien-Dindo classification system
Time frame: Postoperatively (30-day and 90-day)
Operative Time
Total duration in minutes of the surgical procedure measured to evaluate the efficacy of the Hugo RAS system.
Time frame: Intraoperatively
Blood loss
Measurement of blood loss during the surgical procedure. (ml)
Time frame: Intraoperatively.
Conversion Rate
Measurement of conversion rates to open or traditional laparoscopic surgery (%)
Time frame: Intraoperatively.
Length of Hospital Stay
Total length (days) of patient hospital stay post-surgery.
Time frame: At discharge, assessed up to 90 days post-surgery
Hospital Readmission Rate
Rate of hospital readmissions following discharge.
Time frame: Up to 90 days post-surgery
Pathological Outcomes: Margin Status and Lymph Node Yield
Assessment of pathological outcomes, specifically evaluating margin status and lymph node yield.
Time frame: Up to 30 days post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Disease Recurrence Rate
Monitoring of disease recurrence rates post-surgery.
Time frame: Up to 5 years post-surgery
Overall and Disease-Free Survival
Collection of survival data, specifically overall survival and disease-free survival rates.
Time frame: Up to 5 years post-surgery
Long-term Functional Outcomes
Assessment of long-term functional outcomes, such as bowel function.
Time frame: Long-term follow-up (e.g., 1 year, 3 years post-surgery).
Bowel Function Assessed by the LARS Score
Bowel function will be evaluated using the unabbreviated Low Anterior Resection Syndrome (LARS) score questionnaire. The total score ranges from 0 to 42. A score of 0 to 20 indicates no LARS, 21 to 29 indicates minor LARS, and 30 to 42 indicates major LARS. Higher scores indicate worse bowel function and a worse outcome.
Time frame: Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery
Fecal Incontinence Assessed by the Wexner Scale
Fecal incontinence will be evaluated using the Cleveland Clinic (Wexner) Fecal Incontinence Score. The scale assesses the frequency of different types of incontinence and lifestyle alterations. The total score ranges from 0 to 20, where 0 represents perfect continence and 20 represents complete incontinence. Higher scores indicate more severe incontinence and a worse outcome.
Time frame: Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery
Quality of Life Assessed by the EORTC QLQ-C30
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). All scale and single-item measures are linearly transformed to a score ranging from 0 to 100. For the global health status and functional scales, a higher score represents a better level of functioning and a better quality of life. For the symptom scales and items, a higher score represents a higher level of symptomatology and a worse quality of life.
Time frame: Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery
Health-Related Quality of Life Assessed by the EQ-5D-3L
Health status will be evaluated using the EuroQol-5 Dimension-3 Level (EQ-5D-3L) questionnaire. This tool consists of a descriptive system and a Visual Analogue Scale (VAS). The descriptive system assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which are converted into a single health utility index score (typically ranging from less than 0 to 1.0, where 1.0 represents full health). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0 to 100. For both the index score and the VAS, higher scores indicate a better health status and a better outcome.
Time frame: Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery