Clinical trial NCT05734300: The "SPARCOL" Study
Official title: Organ SPARring Surgery vs. Standard Resection for Early Stage COLon Cancer in Elderly Frail Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Frailty
Keywords: Colon Cancer
Elderly population
Early colo-rectal cancer
Organ Preserving Approach
Combined Endoscopic Laparoscopic Surgery (CELS)
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in patient-reported postoperative recovery - Quality of Recovery 15
timeFrame: 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:
measure: Change in exercise capacity and physical condition
timeFrame: 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.
measure: Change in exercise capacity and physical condition
timeFrame: 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.
measure: Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire - EORTC C30.
timeFrame: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
measure: Changes in The European Organization for Research and Treatment of Cancer quality of life questionnaire- EORTC CRC.
timeFrame: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
measure: Frailty questionnaire Geriatric 8 (G8)
timeFrame: Basline
measure: Duration of surgery
timeFrame: Intraoperative
measure: Blood loss
timeFrame: Intraoperative
measure: Intraoperative complications
timeFrame: Intraoperative
measure: Conversion rate
timeFrame: Intraoperative
measure: Rate of complete resection margin
timeFrame: Postoperative day 14
measure: Assessment of histopathological risk factors
timeFrame: Postoperative day 14
measure: Long-term oncological outcomes: Disease-free survival
timeFrame: During 3-year follow-up periode
measure: Long-term oncological outcomes: Overall survival
timeFrame: During 3-year follow-up periode
measure: Long-term oncological outcomes: Recurrence
timeFrame: During 3-year follow-up periode
measure: Clavien-Dindo classification
timeFrame: Within 90 days postoperative.
measure: The Comprehensive Complication Index
timeFrame: Within 90 days postoperative.
measure: Length of hospital stay
timeFrame: Within 90 days postoperative.
measure: 90-day mortality
timeFrame: Within 90 days postoperative.
measure: Hospital readmissions
timeFrame: Within 90 days postoperative.
measure: Rate of secondary standard resection
timeFrame: Within 90 days postoperative.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Herlev
state: Herlev
city: Aabenraa
country: Denmark
facility: Hospital Soenderjylland
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
References: