The Hugo RAS Colorectal Collaborative (HRCC): An International Study to Advance Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 主要终点
- Complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients unable to provide informed consent
研究组 & 干预措施
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.
结局指标
主要结局
Complications
时间窗: 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
时间窗: Postoperatively (30-day and 90-day)
Number and severity of postoperative complications assessed using the Clavien-Dindo classification system
Operative Time
时间窗: Intraoperatively
Total duration in minutes of the surgical procedure measured to evaluate the efficacy of the Hugo RAS system.
Blood loss
时间窗: Intraoperatively.
Measurement of blood loss during the surgical procedure. (ml)
Conversion Rate
时间窗: Intraoperatively.
Measurement of conversion rates to open or traditional laparoscopic surgery (%)
Length of Hospital Stay
时间窗: At discharge, assessed up to 90 days post-surgery
Total length (days) of patient hospital stay post-surgery.
Hospital Readmission Rate
时间窗: Up to 90 days post-surgery
Rate of hospital readmissions following discharge.
Pathological Outcomes: Margin Status and Lymph Node Yield
时间窗: Up to 30 days post-surgery
Assessment of pathological outcomes, specifically evaluating margin status and lymph node yield.
Disease Recurrence Rate
时间窗: Up to 5 years post-surgery
Monitoring of disease recurrence rates post-surgery.
Overall and Disease-Free Survival
时间窗: Up to 5 years post-surgery
Collection of survival data, specifically overall survival and disease-free survival rates.
Long-term Functional Outcomes
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Matteo Rottoli
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna