Combined Endoscopic Laparoscopic Surgery for Colon Cancer
The "SPARCOL" Study
Recruiting
N/AInterventional Study
Colon CancerFrailty
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
48 (estimated)
Sponsor
Zealand University Hospital · Other
Who this trial is looking for
This trial is looking for older adults with small colon cancers to see if a new surgery method helps them recover better than standard surgery. Participants will need to give informed consent and meet certain health criteria.
Are You a Good Fit for This Trial?
You may be able to join if
I am 75 years old or older.
I have colon cancer.
I can provide informed consent.
I have cancer that is at T1 or T2 stage.
My cancer is not too large or involving nearby structures.
You may not be able to join if
I cannot give informed consent.
I have high-risk features in my tumor biopsy.
I have another type of cancer.
I have had chemotherapy or radiotherapy before surgery.
I need a stoma created during surgery.
I do not speak Danish.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 ar…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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 Criteria:
* 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
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