The "SPARCOL" Study

Официальное название

Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients

Обзор

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.

Вмешательства

• Процедура Combined Endoscopic Laparoscopic Surgery (CELS)
  The main surgical advantage in this procedure is the ability to view the colon intra- and extraluminal simultaneously. The laparoscopic approach enables manipulation and mobilization of the colon, while the endoscopic view secures that the resection is complete and not overlapping the ileac valve or creating stenosis. Compared to the traditional oncological colon resection, the CELS resection is a minimally invasive procedure - organ sparing procedure leading to a reduced surgical stress respon
• Процедура Standard resection
  In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.

Первичные конечные точки

• Change in patient-reported postoperative recovery - Quality of Recovery 15 [Срок оценки: 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]

Вторичные конечные точки (12)

• Change in exercise capacity and physical condition [Срок оценки: 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.]
• Change in exercise capacity and physical condition [Срок оценки: 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.]
• Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire - EORTC C30. [Срок оценки: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up]
• Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire- EORTC CRC. [Срок оценки: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up]
• Frailty questionnaire Geriatric 8 (G8) [Срок оценки: Basline]
• Duration of surgery [Срок оценки: Intraoperative]
• Blood loss [Срок оценки: Intraoperative]
• Intraoperative complications [Срок оценки: Intraoperative]
• Conversion rate [Срок оценки: Intraoperative]
• Rate of complete resection margin [Срок оценки: Postoperative day 14]
• Assessment of histopathological risk factors [Срок оценки: Postoperative day 14]
• Long-term oncological outcomes: Disease-free survival [Срок оценки: During 3-year follow-up periode]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Дания · 3 центра

• Copenhagen University Hospital - Herlev — Copenhagen
• Hospital Soenderjylland — Aabenraa
• Zealand University Hospital — Køge

Идентификаторы

NCT: NCT05734300 · EMN 2022-04791

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗