Surgical Site Infection Outcomes in Robotic Natural Orifice Colorectal Resection - The NICE Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure
研究概览
简要总结
The goal of this observational study is to learn if a new surgical technique, called the NICE procedure, is as safe as standard methods for treating benign left-sided colon and rectal diseases in adults. The main question it aims to answer is:
Does the NICE procedure lead to similar or lower rates of surgical site infections (SSIs) within 30 days compared to traditional surgery?
Researchers will gather information from hospitals across the country to evaluate how well this procedure works when performed by experienced surgeons in everyday clinical settings.
Participants will:
Have surgery using the NICE procedure, which uses a robotic platform and removes the specimen through a natural opening (the rectum).
Be monitored for any infections or complications after surgery.
Complete surveys to track their recovery, bowel function, and quality of life for up to 6 months.
This study may help improve recovery, reduce pain, and lower infection risk in future colorectal surgeries.
详细描述
Background and Rationale The Natural Orifice Intracorporeal Anastomosis and Extraction (NICE) procedure represents an emerging innovation in minimally invasive colorectal surgery. It combines robotic intracorporeal anastomosis (ICA) with natural orifice specimen extraction (NOSE), typically transrectal, to avoid the need for an abdominal extraction incision. This approach may reduce surgical site trauma, postoperative pain, opioid use, and rates of incisional hernias.
Intracorporeal anastomosis has been widely studied in right-sided colectomies, with consistent evidence showing reduced surgical site infections (SSIs) and improved recovery. However, application to left-sided resections introduces unique challenges. The bacterial density in the left colon and rectum, combined with transrectal manipulation, may increase the risk of deep or organ-space SSIs. While early single-center experiences suggest the NICE procedure may be safe and effective, multicenter validation in a broader clinical setting is needed.
Study Objectives The primary objective of this study is to determine the 30-day incidence of surgical site infections (superficial, deep, and organ-space) in patients undergoing robotic left-sided colorectal resections using the NICE procedure. Secondary objectives include assessment of intraoperative technical performance, perioperative complications, postoperative recovery, and longer-term functional and quality of life outcomes.
Study Design This is a prospective, multicenter, observational cohort study enrolling patients undergoing elective robotic-assisted left colectomy or rectosigmoid resection for benign colorectal disease. All procedures will use the standardized NICE technique. Participating surgeons must have performed at least 20 prior NICE procedures. The study will run over a 24-month accrual period, with each patient followed for at least 6 months postoperatively.
Study Procedures Surgical intervention involves robotic left-sided resection with intracorporeal anastomosis and transrectal specimen extraction. All sites will follow a standardized Enhanced Recovery After Surgery (ERAS) protocol tailored to robotic colorectal surgery. Operative videos will be collected for quality control, ensuring adherence to the defined NICE procedural steps.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
30-Day Surgical Site Infection (SSI) Rate Following the NICE Procedure
时间窗: 30 days post-surgery
Measures the proportion of patients who develop surgical site infections (SSIs) categorized as superficial, deep, or organ-space within 30 days following robotic left-sided colectomy or rectosigmoid resection using the NICE procedure. Infections are classified per CDC definitions and assessed through clinical evaluation, medical records, and follow-up.
次要结局
- Oversewing of Anastomosis(During surgery)
- Performance of Mesenteric Shaving(During surgery)
- Long-Term Outcomes: Hernia, Bowel Dysfunction, Fecal Incontinence(Up to 6 months post-surgery)
- Stool Contamination Grade During NICE Procedure(During surgery)
- Estimated Intraoperative Blood Loss(During surgery)
- Total Operative Time(During surgery)
- Success Rate of Intracorporeal Anastomosis(During surgery)
- Success Rate of Transrectal Specimen Extraction(During surgery)
- Incidence of Intraoperative Complications(During surgery)
- Total Opioid Use Within 30 Days Post-Surgery(30 days post-surgery)
- Length of Hospital Stay(30 days post-surgery)
- Overall Postoperative Complication Rate(30 days post-surgery)
- Reoperation or Re-intervention Rate(30 days post-surgery)
- Readmission Rate Within 30 Days(30 days post-surgery)
- Postoperative Mortality Rate(30 days post-surgery)
- Use of Transrectal Wound Protector(During surgery)
- Type of Intracorporeal Anastomosis Staple Line(During surgery)
- Change in Wexner Score for Fecal Incontinence(Baseline, 3 months, 12 months)
- Functional Outcomes: LARS Score(Baseline, 3 months, 12 months)
- Health-Related Quality of Life: PROMS-10 Score(Baseline, 3 months, 12 months)
研究者
Eric M. Haas
Chief of the Division of Colon & Rectal Surgery
The Methodist Hospital Research Institute