ColoRectal Cancer and Inflammatory Bowel Disease, Colorectal Surgery, Robotic Surgery
Conditions
Keywords
Colorectal cancer, IBD, Robotic surgery
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (age ≥ 18 years) * Scheduled to undergo any type of colorectal surgery (elective or emergent) where the Hugo RAS system is planned to be used * Willing and able to provide written informed consent
Exclusion criteria
-Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | Intraoperatively | 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. |
| Rate of Postoperative Complications | Postoperatively (30-day and 90-day) | Number and severity of postoperative complications assessed using the Clavien-Dindo classification system |
| Operative Time | Intraoperatively | Total duration in minutes of the surgical procedure measured to evaluate the efficacy of the Hugo RAS system. |
| Blood loss | Intraoperatively. | Measurement of blood loss during the surgical procedure. (ml) |
| Conversion Rate | Intraoperatively. | Measurement of conversion rates to open or traditional laparoscopic surgery (%) |
| Length of Hospital Stay | At discharge, assessed up to 90 days post-surgery | Total length (days) of patient hospital stay post-surgery. |
| Hospital Readmission Rate | Up to 90 days post-surgery | Rate of hospital readmissions following discharge. |
| Pathological Outcomes: Margin Status and Lymph Node Yield | Up to 30 days post-surgery | Assessment of pathological outcomes, specifically evaluating margin status and lymph node yield. |
| Disease Recurrence Rate | Up to 5 years post-surgery | Monitoring of disease recurrence rates post-surgery. |
| Overall and Disease-Free Survival | Up to 5 years post-surgery | Collection of survival data, specifically overall survival and disease-free survival rates. |
| Long-term Functional Outcomes | Long-term follow-up (e.g., 1 year, 3 years post-surgery). | Assessment of long-term functional outcomes, such as bowel function. |
| Bowel Function Assessed by the LARS Score | Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery | 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. |
| Fecal Incontinence Assessed by the Wexner Scale | Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery | 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. |
| Quality of Life Assessed by the EORTC QLQ-C30 | Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery | 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. |
| Health-Related Quality of Life Assessed by the EQ-5D-3L | Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery | 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. |
Contacts
CONTACTMatteo Rottoli, MD, PhD
Outcome results
None listed