Actively Recruiting
The "SPARCOL" Study
Led by Zealand University Hospital · Updated on 2023-07-25
48
Participants Needed
3
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The "SPARCOL" Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and Female participants providing written informed consent aged 75 years and older
- Performance Status score 1 or higher and/or ASA score 3 or higher
- Macroscopically or pathological confirmed colonic adenocarcinoma
- Clinical TNM classification T1/T2 N0 M0
- Eligible and suitable for Combined Endoscopic Laparoscopic Surgery (CELS) resection according to multidisciplinary team
- Tumor located in colon, not involving the ileac valve or occupying more than 50% of the lumen in an air-distended bowel
You will not qualify if you...
- Unable to give informed consent
- Histological high-risk features in tumor biopsy (mucin, signet cells, de-differentiation)
- Suspected malignancy other than adenocarcinoma (e.g. neuroendocrine tumors)
- Preoperative chemotherapy or radiotherapy
- Creation of stoma perioperative
- Non-Danish speakers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Copenhagen University Hospital - Herlev
Copenhagen, Herlev, Denmark, 2730
Actively Recruiting
2
Hospital Soenderjylland
Aabenraa, Denmark, 6200
Active, Not Recruiting
3
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
Research Team
I
Ilze Ose, MD
CONTACT
I
Ismail Gögenur, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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