Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT05734300

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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The "SPARCOL" Study | DecenTrialz