NCT05734300Recruiting
The "SPARCOL" Study
Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
Source: ClinicalTrials.gov · Last updated 25 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- 1 May 2023
- Primary completion date
- 1 May 2025
- Lead sponsor
- Zealand University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05734300
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 1 May 2023 to the primary completion date, 1 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Preoperative chemo/radiotherapy
Other illness
- Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)
Other
- Unable to give informed consent
- Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)
- Creation of stoma perioperative
- Non-Danish speakers
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Soenderjylland Coordinator of this site? Confirm its status | Aabenraa | Denmark | Active, not recruiting |
| Copenhagen University Hospital - Herlev Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Zealand University Hospital Coordinator of this site? Confirm its status | Køge | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.