Colorectal SurgeryHRCCNCT07541352
The Hugo RAS Colorectal Collaborative
An observational study of Colorectal Surgery and Robotic Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Robotic Surgery, ColoRectal Cancer and Inflammatory Bowel Disease
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -Patients unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Keywords
- Colorectal cancer, IBD, Robotic surgery
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively
Rate of Postoperative Complications
Number and severity of postoperative complications assessed using the Clavien-Dindo classification system
Measured: 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.
Measured: Intraoperatively
Blood loss
Measurement of blood loss during the surgical procedure. (ml)
Measured: Intraoperatively.
Conversion Rate
Measurement of conversion rates to open or traditional laparoscopic surgery (%)
Measured: Intraoperatively.
Length of Hospital Stay
Total length (days) of patient hospital stay post-surgery.
Measured: At discharge, assessed up to 90 days post-surgery
Hospital Readmission Rate
Rate of hospital readmissions following discharge.
Measured: 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.
Measured: Up to 30 days post-surgery
Disease Recurrence Rate
Monitoring of disease recurrence rates post-surgery.
Measured: Up to 5 years post-surgery
Overall and Disease-Free Survival
Collection of survival data, specifically overall survival and disease-free survival rates.
Measured: Up to 5 years post-surgery
Long-term Functional Outcomes
Assessment of long-term functional outcomes, such as bowel function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 1 year, 2 years, and 3 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Rottoli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541352
- Sponsor's protocol ID
- HRCC
- Acronym
- HRCC
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 38448626Rottoli 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.
PubMed 39349880Cheng CL, Rezac C. The role of robotics in colorectal surgery. BMJ. 2018 Feb 12;360:j5304. doi: 10.1136/bmj.j5304.
PubMed 29440057Irani 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.
PubMed 36515747
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hugo RAS Colorectal Collaborative (HRCC): An International Study to Advance Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT07541352
- Acronym / sponsor ID
- HRCC / HRCC
- Keywords
- Colorectal cancer, IBD, Robotic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Operative Time
Time frame: Intraoperatively
Total duration in minutes of the surgical procedure measured to evaluate the efficacy of the Hugo RAS system.
Blood loss
Time frame: Intraoperatively.
Measurement of blood loss during the surgical procedure. (ml)
Conversion Rate
Time frame: Intraoperatively.
Measurement of conversion rates to open or traditional laparoscopic surgery (%)
Length of Hospital Stay
Time frame: At discharge, assessed up to 90 days post-surgery
Total length (days) of patient hospital stay post-surgery.
Hospital Readmission Rate
Time frame: Up to 90 days post-surgery
Rate of hospital readmissions following discharge.
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.
Disease Recurrence Rate
Time frame: Up to 5 years post-surgery
Monitoring of disease recurrence rates post-surgery.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 38448626Romero-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.
- Background: PubMed 39349880Rottoli 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.
- Background: PubMed 29440057Cheng CL, Rezac C. The role of robotics in colorectal surgery. BMJ. 2018 Feb 12;360:j5304. doi: 10.1136/bmj.j5304.
- Background: PubMed 36515747Irani 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery and Robotic Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Rottoli, MD, PhD (+390516364823, matteo.rottoli@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Intraoperatively). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07541352, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.