The "SPARCOL" Study

NCT05734300 | Recruiting DMC

• 1 other identifier: EMN 2022-04791
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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

Keywords

Colon Cancer; Elderly population; Early colo-rectal cancer; Organ Preserving Approach; Combined Endoscopic Laparoscopic Surgery (CELS)

Outcome Measures

Primary Outcomes (1)

• Change in patient-reported postoperative recovery - Quality of Recovery 15

  Validated to measure recovery after surgery and general anesthesia, and additionally validated for use in Danish language and culture. The scale is arbitrary and ranges from 0 to 150. Higher scores means better recovery. The established minimum clinically important difference in QoR-15 is 8.0, and the SD of QoR- 15 scores after major surgery is in the order of 16.

  Change in QoR-15 will be assessed repeatedly at baseline, 4-8 hours postoperatively (4-8H), postoperative day (POD) 1, POD 2, POD 3, POD 7, POD 10-14 and POD 30

Secondary Outcomes (20)

• Change in exercise capacity and physical condition

  Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.

• Change in exercise capacity and physical condition

  Changes will be assessed repeatedly at baseline, Postoperative day 1, Postoperative day 2, Postoperative day 3 or at the time of hospital discharge, whatever comes first. Postoperative day 10-14 and 30 days postoperatively.

• Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire - EORTC C30.

  Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up

• Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire- EORTC CRC.

  Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up

• Frailty questionnaire Geriatric 8 (G8)

  Basline

Study Arms (2)

CELS

EXPERIMENTAL

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.

Procedure: Combined Endoscopic Laparoscopic Surgery (CELS)

Standard Surgery

ACTIVE COMPARATOR

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

Procedure: Standard resection

Interventions

Combined Endoscopic Laparoscopic Surgery (CELS) 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.

CELS

Standard resection PROCEDURE

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

Standard Surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (3)

Copenhagen University Hospital - Herlev

Copenhagen, Herlev, 2730, Denmark

RECRUITING

Hospital Soenderjylland

Aabenraa, 6200, Denmark

ACTIVE NOT RECRUITING

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ilze Ose, MD

CONTACT

27293399; ilos@regionsjaelland.dk

Ismail Gögenur, Prof.

CONTACT

26336426; igo@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 17, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

DK (3)