MedTrace Logo

The "SPARCOL" Study

NCT05734300 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-07-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-05-01
Completion
2027-09-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734300 on ClinicalTrials.gov