| NCT ID | NCT05734300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zealand University Hospital |
| Condition | Colon Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2023-05-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 Criteria: * Unable to give informed consent * Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation) * Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors) * Preoperative chemo/radiotherapy * Creation of stoma perioperative * Non-Danish speakers
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05734300 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Colon Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05734300 currently recruiting?
Yes, NCT05734300 is actively recruiting participants. Contact the research team at ilos@regionsjaelland.dk for enrollment information.
Where is the NCT05734300 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Aabenraa, Denmark, Køge, Denmark.
Who is sponsoring the NCT05734300 clinical trial?
NCT05734300 is sponsored by Zealand University Hospital. The trial plans to enroll 48 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.