Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Hospital Soenderjylland
ACTIVE_NOT_RECRUITING
Aabenraa
Copenhagen University Hospital - Herlev
RECRUITING
Copenhagen
Zealand University Hospital
RECRUITING
Køge
Contact Information
Primary
Ilze Ose, MD
ilos@regionsjaelland.dk
27293399
Backup
Ismail Gögenur, Prof.
igo@regionsjaelland.dk
26336426
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 48
Treatments
Experimental: CELS
The Combined Endoscopic Laparoscopic Surgery (CELS) is a hybrid procedure that enables large local excisions of the colon without segmental resection while under general anaesthesia. In our study, CELS refers only to endoscopic assisted laparoscopic resection.
Active_comparator: Standard Surgery
Standard surgical resection of colonic cancer following standard oncologic principles while under general anaesthesia.
Related Therapeutic Areas
Sponsors
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov