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Not yet recruiting NCT07541352

The Hugo RAS Colorectal Collaborative

— Observational Colorectal Surgery Robotic Surgery ColoRectal Cancer and Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colorectal Surgery, Robotic Surgery, ColoRectal Cancer and Inflammatory Bowel Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Complications [Time frame: Intraoperatively]
  • Rate of Postoperative Complications [Time frame: Postoperatively (30-day and 90-day)]
  • Operative Time [Time frame: Intraoperatively]
  • Blood loss [Time frame: Intraoperatively.]
  • Conversion Rate [Time frame: Intraoperatively.]
  • Length of Hospital Stay [Time frame: At discharge, assessed up to 90 days post-surgery]
  • Hospital Readmission Rate [Time frame: Up to 90 days post-surgery]
  • Pathological Outcomes: Margin Status and Lymph Node Yield [Time frame: Up to 30 days post-surgery]
  • Disease Recurrence Rate [Time frame: Up to 5 years post-surgery]
  • Overall and Disease-Free Survival [Time frame: Up to 5 years post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 38448626
  • 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
  • Cheng CL, Rezac C. The role of robotics in colorectal surgery. BMJ. 2018 Feb 12;360:j5304. doi: 10.1136/bmj.j5304. PMID 29440057
  • 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 PMID 36515747

Identifiers

NCT: NCT07541352 · HRCC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗