The Hugo RAS Colorectal Collaborative (HRCC)

The Hugo RAS Colorectal Collaborative (HRCC): An International Study to Advance Minimally Invasive Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Surgery; Robotic Surgery; ColoRectal Cancer and Inflammatory Bowel Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Matteo Rottoli, MD, PhD; Phone Number: +390516364823; Email: matteo.rottoli@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

• 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.
• 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.
• Cheng CL, Rezac C. The role of robotics in colorectal surgery. BMJ. 2018 Feb 12;360:j5304. doi: 10.1136/bmj.j5304.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal cancer; Robotic surgery; IBD
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Gastroenteritis; Colorectal Neoplasms; Inflammatory Bowel Diseases
• Other Study ID Numbers: HRCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No