The Hugo RAS Colorectal Collaborative

Primary outcomes

1. Complications

   Time frame: 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.

2. Rate of Postoperative Complications

   Time frame: Postoperatively (30-day and 90-day)

   Number and severity of postoperative complications assessed using the Clavien-Dindo classification system

3. Operative Time

   Time frame: Intraoperatively

   Total duration in minutes of the surgical procedure measured to evaluate the efficacy of the Hugo RAS system.

4. Blood loss

   Time frame: Intraoperatively.

   Measurement of blood loss during the surgical procedure. (ml)

5. Conversion Rate

   Time frame: Intraoperatively.

   Measurement of conversion rates to open or traditional laparoscopic surgery (%)

6. Length of Hospital Stay

   Time frame: At discharge, assessed up to 90 days post-surgery

   Total length (days) of patient hospital stay post-surgery.

7. Hospital Readmission Rate

   Time frame: Up to 90 days post-surgery

   Rate of hospital readmissions following discharge.

8. Pathological Outcomes: Margin Status and Lymph Node Yield

   Time frame: Up to 30 days post-surgery

   Assessment of pathological outcomes, specifically evaluating margin status and lymph node yield.

9. Disease Recurrence Rate

   Time frame: Up to 5 years post-surgery

   Monitoring of disease recurrence rates post-surgery.

10. Overall and Disease-Free Survival

    Time frame: Up to 5 years post-surgery

    Collection of survival data, specifically overall survival and disease-free survival rates.

11. Long-term Functional Outcomes

    Time frame: Long-term follow-up (e.g., 1 year, 3 years post-surgery).

    Assessment of long-term functional outcomes, such as bowel function.

12. Bowel Function Assessed by the LARS Score

    Time frame: 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.

13. Fecal Incontinence Assessed by the Wexner Scale

    Time frame: 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.

14. Quality of Life Assessed by the EORTC QLQ-C30

    Time frame: 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.

15. Health-Related Quality of Life Assessed by the EQ-5D-3L

    Time frame: 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.