The Hugo RAS Colorectal Collaborative

NCT07541352 | Not Yet Recruiting

• 1 other identifier: HRCC
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Surgery; Robotic Surgery; ColoRectal Cancer and Inflammatory Bowel Disease

Keywords

Colorectal cancer; IBD; Robotic surgery

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients unable to provide informed consent

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Related Publications (4)

• 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.

  PMID: 38448626 BACKGROUND

• 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.

  PMID: 39349880 BACKGROUND

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

  PMID: 29440057 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.

  PMID: 36515747 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis

Central Study Contacts

Matteo Rottoli, MD, PhD

CONTACT

+390516364823; matteo.rottoli@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share