The "SPARCOL" Study

Zealand University Hospital

Status: Enrolling

Conditions: Colon Cancer; Frailty

Treatments: Procedure: Combined Endoscopic Laparoscopic Surgery (CELS); Procedure: Standard resection

Study type: Interventional

Funder types: Other

Identifiers

NCT05734300

EMN 2022-04791

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

CELS

Experimental group

Description:

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.

Treatment:

Procedure: Combined Endoscopic Laparoscopic Surgery (CELS)

Standard Surgery

Active Comparator group

Description:

Standard surgical resection of colonic cancer following standard oncologic principles while under general anaesthesia.

Treatment:

Procedure: Standard resection