The "SPARCOL" Study
Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
Zealand University Hospital
48 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria6
- 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
Interventions
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 response.
In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05734300