RecruitingNot ApplicableNCT05734300

The "SPARCOL" Study

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

Sponsor

Zealand University Hospital

Enrollment

48 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colon Cancer Frailty

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

The SPARCOL study tests a minimally invasive surgical approach called combined endoscopic laparoscopic surgery (CELS) for removing early-stage colon cancer (adenocarcinoma) in elderly patients aged 75 and over who are considered higher surgical risk. Traditional bowel surgery can be risky for older or frailer patients, and this less invasive approach may offer a safer alternative while still curing the cancer. **You may be eligible if...** - You are 75 years old or older - You have colon cancer (adenocarcinoma) that is early stage (T1/T2, no lymph node or distant spread) - You are considered higher risk for surgery (physical status score) - Your tumour has been assessed by a specialist team (MDT) as suitable for this technique - You are willing to provide written consent **You may NOT be eligible if...** - You are unable to give informed consent - Your biopsy shows high-risk tumour features (such as mucin or poorly differentiated cells) - You are suspected to have a cancer type other than adenocarcinoma - You have had or need chemotherapy or radiation before surgery - You don't speak Danish (as the study is based in Denmark) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECombined 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 response.

PROCEDUREStandard resection

In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.