Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change in patient-reported postoperative recovery - Quality of Recovery 15
研究概览
简要总结
Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. A part of the colon is always removed together with the lymph nodes in order to ensure that cancer cells are not left behind. The risk of lymph node metastasis is dependent on several histopathological characteristics of the tumor. The overall risk of lymph node metastases is less than 20 % in patients with early colon cancer. This indicates that the majority of patients with early colon cancer have no benefit of additional resection besides local tumor excision. The alternative to resecting a larger part of the bowel is to make more focused surgery only resecting a small part of the bowel part through a combination of laparoscopic and endoscopic techniques. This new organ sparing approach is called Combined Endoscopic Laparoscopic Surgery (CELS). The investigators aimed to examinate the hypothesis that organ preserving approach (CELS) provides superior quality of recovery in elderly frail patients with small colon cancers when compared with standard surgery in RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants providing written informed consent aged 75 years and older
- •PS score ≥1 and /or ASA score ≥3
- •Macroscopically or pathological colonic adenocarcinoma
- •Clinical TNM classification T1/T2 N0 M0
- •Eligible and suitable for CELS resection according to MDT
- •Tumor must be located in colon, and not involving the ileac valve or taking up more than 50% of the lumen in an air-distended bowel wall
排除标准
- •Unable to give informed consent
- •Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)
- •Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)
- •Preoperative chemo/radiotherapy
- •Creation of stoma perioperative
- •Non-Danish speakers
结局指标
主要结局
Change in patient-reported postoperative recovery - Quality of Recovery 15
时间窗: Change in QoR-15 will be assessed repeatedly at baseline, 4-8 hours postoperatively (4-8H), postoperative day (POD) 1, POD 2, POD 3, POD 7, POD 10-14 and POD 30
Validated to measure recovery after surgery and general anesthesia, and additionally validated for use in Danish language and culture. The scale is arbitrary and ranges from 0 to 150. Higher scores means better recovery. The established minimum clinically important difference in QoR-15 is 8.0, and the SD of QoR- 15 scores after major surgery is in the order of 16.
次要结局
- Intraoperative complications(Intraoperative)
- Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire- EORTC CRC.(Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up)
- Blood loss(Intraoperative)
- Rate of complete resection margin(Postoperative day 14)
- Length of hospital stay(Within 90 days postoperative.)
- Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire - EORTC C30.(Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up)
- Duration of surgery(Intraoperative)
- Frailty questionnaire Geriatric 8 (G8)(Basline)
- Assessment of histopathological risk factors(Postoperative day 14)
- Long-term oncological outcomes: Disease-free survival(During 3-year follow-up periode)
- The Comprehensive Complication Index(Within 90 days postoperative.)
- Long-term oncological outcomes: Overall survival(During 3-year follow-up periode)
- 90-day mortality(Within 90 days postoperative.)
- Rate of secondary standard resection(Within 90 days postoperative.)
- Conversion rate(Intraoperative)
- Long-term oncological outcomes: Recurrence(During 3-year follow-up periode)
- Clavien-Dindo classification(Within 90 days postoperative.)
- Hospital readmissions(Within 90 days postoperative.)
- Change in exercise capacity and physical condition(Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.)