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Recruiting NCT05734300

The "SPARCOL" Study

Conditions: Colon Cancer, Frailty

Sex: All
Ages: 75 Years – N/A
Phase: NA
Enrollment: 48
Sponsor: Zealand University Hospital

Location: Denmark

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 Criteria

Inclusion Criteria:Male and Female participants providing written informed consent aged 75 years and olderPS score ≥1 and /or ASA score ≥3Macroscopically or pathological colonic adenocarcinomaClinical TNM classification T1/T2 N0 M0Eligible and suitable for CELS resection according to MDTTumor 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 wallExclusion Criteria:Unable to give informed consentHistological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)Preoperative chemo/radiotherapyCreation of stoma perioperativeNon-Danish speakers

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05734300). StuddyBuddy aggregates publicly available trial information.