The "SPARCOL" Study

NCT ID: NCT05734300

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2027-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Combined Endoscopic Laparoscopic Surgery (CELS)

Intervention Type: PROCEDURE

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.

Standard Surgery

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

Group Type: ACTIVE_COMPARATOR

Standard resection

Intervention Type: PROCEDURE

In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.

Interventions

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.

Intervention Type: PROCEDURE

Standard resection

In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Copenhagen University Hospital - Herlev

Copenhagen, Herlev, Denmark

Site Status: RECRUITING

Hospital Soenderjylland

Aabenraa, , Denmark

Site Status: ACTIVE_NOT_RECRUITING

Zealand University Hospital

Køge, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ilze Ose, MD

Role: CONTACT

ilos@regionsjaelland.dk

27293399 ext. 0045

Ismail Gögenur, Prof.

Role: CONTACT

igo@regionsjaelland.dk

26336426 ext. 0045

Facility Contacts

Mads Falk Klein

Role: primary

mads.falk.klein@regionh.dk

38681543 ext. 0045

Henrik Loft Jacobsen

Role: backup

Ilze Ose, Prof.

Role: primary

ilos@regionsjaelland.dk

27293399 ext. 0045

Ismail Gögenur

Role: backup

igo@regionsjaelland.dk

26336426 ext. 0045

Other Identifiers

EMN 2022-04791

Identifier Type: -

Identifier Source: org_study_id