The "SPARCOL" Study

Trial Title: The "SPARCOL" Study

NCT ID: NCT05734300

Condition: Colon Cancer
Frailty

Conditions: Official terms:
Colonic Neoplasms
Frailty

Conditions: Keywords:
Colon Cancer
Elderly population
Early colo-rectal cancer
Organ Preserving Approach
Combined Endoscopic Laparoscopic Surgery (CELS)

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Combined Endoscopic Laparoscopic Surgery (CELS)
Description: The main surgical advantage in this procedure is the ability to view the colon intra- and extraluminal simultaneously. The laparoscopic approach enables manipulation and mobilization of the colon, while the endoscopic view secures that the resection is complete and not overlapping the ileac valve or creating stenosis. Compared to the traditional oncological colon resection, the CELS resection is a minimally invasive procedure - organ sparing procedure leading to a reduced surgical stress response.
Arm group label: CELS

Intervention type: Procedure
Intervention name: Standard resection
Description: In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.
Arm group label: Standard Surgery

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.

Criteria for 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

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Copenhagen University Hospital - Herlev

Address:
City: Copenhagen
Zip: 2730
Country: Denmark

Status: Recruiting

Contact:
Last name: Mads Falk Klein

Phone: 38681543

Phone ext: 0045
Email: mads.falk.klein@regionh.dk

Contact backup:
Last name: Henrik Loft Jacobsen

Facility:
Name: Hospital Soenderjylland

Address:
City: Aabenraa
Zip: 6200
Country: Denmark

Status: Active, not recruiting

Facility:
Name: Zealand University Hospital

Address:
City: Køge
Zip: 4600
Country: Denmark

Status: Recruiting

Contact:
Last name: Ilze Ose, Prof.

Phone: 27293399

Phone ext: 0045
Email: ilos@regionsjaelland.dk

Contact backup:
Last name: Ismail Gögenur

Phone: 26336426

Phone ext: 0045
Email: igo@regionsjaelland.dk

Start date: May 1, 2023

Completion date: September 1, 2027

Lead sponsor:
Agency: Zealand University Hospital
Agency class: Other

Source: Zealand University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05734300