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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing Hugo RAS colorectal surgery | Adult patients (≥18 years) scheduled to undergo any type of elective or emergent colorectal surgery utilizing the Hugo™ RAS (Robotic-Assisted Surgery) System at participating high-volume colorectal surgery centers. The intervention of interest is the use of the Hugo RAS System, a medical device manufactured by Medtronic, which consists of a surgeon console, robotic arms with instrument manipulators, and a vision cart. The system is intended for performing minimally invasive colorectal surgical procedures. Because this is an observational study, patients will receive treatment according to the standard clinical practice of the participating centers. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperatively |
| Rate of Postoperative Complications | Number and severity of postoperative complications assessed using the Clavien-Dindo classification system | 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. | Intraoperatively |
| Blood loss | Measurement of blood loss during the surgical procedure. (ml) | Intraoperatively. |
| Conversion Rate | Measurement of conversion rates to open or traditional laparoscopic surgery (%) | Intraoperatively. |
| Length of Hospital Stay | Total length (days) of patient hospital stay post-surgery. | At discharge, assessed up to 90 days post-surgery |
| Hospital Readmission Rate | Rate of hospital readmissions following discharge. | Up to 90 days post-surgery |
| Pathological Outcomes: Margin Status and Lymph Node Yield |
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Inclusion Criteria:
Exclusion Criteria:
-Patients unable to provide informed consent
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Adult patients (≥18 years) undergoing any type of elective or emergent colorectal surgery using the Hugo RAS system. The population will be drawn from participating high-volume colorectal surgery centers across multiple countries. All eligible patients at these centers will be enrolled to minimize selection bias.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Rottoli, MD, PhD | Contact | +390516364823 | matteo.rottoli@unibo.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38448626 | Background | Romero-Marcos JM, Sampson-Davila JG, Cuenca-Gomez C, Altet-Torne J, Gonzalez-Abos S, Ojeda-Jimenez I, Galaviz-Sosa ML, Delgado-Rivilla S. Colorectal procedures with the novel Hugo RAS system: training process and case series report from a non-robotic surgical team. Surg Endosc. 2024 Apr;38(4):2160-2168. doi: 10.1007/s00464-024-10760-8. Epub 2024 Mar 6. | |
| 39349880 |
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Requests for access to anonymized individual patient-level data by external researchers will be considered on a case-by-case basis by the HRCC steering committee. A formal data sharing agreement outlining the terms of use, data security, and publication policies will be required. The primary aim is to protect patient confidentiality and ensure that data is used responsibly for advancing scientific knowledge in line with the registry's objectives.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2025 | Mar 20, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Assessment of pathological outcomes, specifically evaluating margin status and lymph node yield. |
| Up to 30 days post-surgery |
| Disease Recurrence Rate | Monitoring of disease recurrence rates post-surgery. | Up to 5 years post-surgery |
| Overall and Disease-Free Survival | Collection of survival data, specifically overall survival and disease-free survival rates. | Up to 5 years post-surgery |
| Long-term Functional Outcomes | Assessment of long-term functional outcomes, such as bowel function. | 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. | 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. | 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. | 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. | Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery |
| Rottoli M, Violante T, Calini G, Cardelli S, Novelli M, Poggioli G. A multi-docking strategy for robotic LAR and deep pelvic surgery with the Hugo RAS system: experience from a tertiary referral center. Int J Colorectal Dis. 2024 Oct 1;39(1):154. doi: 10.1007/s00384-024-04728-2. |
| 29440057 | Background | Cheng CL, Rezac C. The role of robotics in colorectal surgery. BMJ. 2018 Feb 12;360:j5304. doi: 10.1136/bmj.j5304. |
| 36515747 | Background | Irani JL, Hedrick TL, Miller TE, Lee L, Steinhagen E, Shogan BD, Goldberg JE, Feingold DL, Lightner AL, Paquette IM. Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons and the Society of American Gastrointestinal and Endoscopic Surgeons. Surg Endosc. 2023 Jan;37(1):5-30. doi: 10.1007/s00464-022-09758-x. Epub 2022 Dec 14. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005759 | Gastroenteritis |