Testing a gentler surgery for early colon cancer in frail older adults
Compares a smaller, bowel-sparing operation with standard removal in frail older adults.
Plain-language title generated from the registry record
Registry title: The "SPARCOL" Study
Key facts
- Where
- Aabenraa, Copenhagen, and Køge, DenmarkSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for frail people aged 75 or older with early colon cancer that has not spread. It compares a smaller operation that spares the bowel with standard surgery.
- Age
- 75 years and older (the registry also lists a minimum age of 65 years).
- Sex
- Men and women can join.
- Disease stage
- Early colon cancer (adenocarcinoma), clinical stage T1/T2 N0 M0. The tumour must be in the colon, must not involve the ileac valve, and must not take up more than 50% of the bowel lumen when the bowel is filled with air.
- Earlier treatment
- No chemotherapy or radiotherapy before the operation.
Main reasons for not taking part
- Cannot give informed consent
- High-risk features in the tumour biopsy (mucin, signet cells, de-differentiation)
- Suspected cancer other than adenocarcinoma, such as neuroendocrine tumours
- A stoma is created during the operation
- Does not speak Danish
Read by machine on 9 November 2026.
Where in Denmark
- Hospital SoenderjyllandAabenraa, DenmarkNo longer taking part
- Copenhagen University Hospital - HerlevCopenhagen, DenmarkTaking people
- Zealand University HospitalKøge, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zealand University Hospital
- Trial code
- NCT05734300
- Record updated
- 25 July 2023
- Original description
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.Read full original descriptionShow less
Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
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.
Inclusion: 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: Preoperative chemo/radiotherapy; Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors); 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.