NCT05734300

The "SPARCOL" Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Frailty

Interventions

Type	Name	Description
PROCEDURE	Combined Endoscopic Laparoscopic Surgery (CELS)	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.
PROCEDURE	Standard resection	In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2027-09-01
• First posted: 2023-02-17
• Last updated: 2023-07-25

Locations

3 sites across 1 country: Denmark