The "SPARCOL" Study
- Conditions
- Colon CancerFrailty
- Interventions
- Procedure: Standard resectionProcedure: Combined Endoscopic Laparoscopic Surgery (CELS)
- Registration Number
- NCT05734300
- Lead Sponsor
- Zealand University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Surgery Standard resection Standard surgical resection of colonic cancer following standard oncologic principles while under general anaesthesia. CELS Combined Endoscopic Laparoscopic Surgery (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.
- Primary Outcome Measures
Name Time Method Change in patient-reported postoperative recovery - Quality of Recovery 15 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 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.
- Secondary Outcome Measures
Name Time Method Blood loss Intraoperative Blood loss in ml
Duration of surgery Intraoperative Duration of surgery in minutes
Intraoperative complications Intraoperative Descriptive registration of intraoperative complications;
Rate of complete resection margin Postoperative day 14 R0 (tumor-free margin \>1 mm) corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor.
Length of hospital stay Within 90 days postoperative. Clinical metric that measures the length of time in days elapsed between a patient's hospital admittance and discharge.
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 EORTC CRC questionnaire, developed to assess the quality of life of cancer patients. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
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. Six minutes' walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
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 EORTC C30, questionnaire, developed to assess the quality of life of cancer patients. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Frailty questionnaire Geriatric 8 (G8) Basline The G-8 Score is a screening tool containing 8 questions. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.
Assessment of histopathological risk factors Postoperative day 14 Assessment of histopathological risk factor defined as presence of at least one of the risk factors: Kikuchi level ≥sm2, vascular invasion, lymphatic invasion, poorly differentiated adenocarcinoma, and tumour budding BD2-3.
Long-term oncological outcomes: Disease-free survival During 3-year follow-up periode Time from surgery until the recurrence of disease or death
The Comprehensive Complication Index Within 90 days postoperative. e Comprehensive Complication Index (CCI®) reflects the gravity of this overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)
Long-term oncological outcomes: Overall survival During 3-year follow-up periode Overall survival was defined as the time elapsed from the date of surgery to the last day of follow-up or the date of death
90-day mortality Within 90 days postoperative. Death within 90 days after surgery, as either an inpatient or outpatient
Rate of secondary standard resection Within 90 days postoperative. Rate in percent of performed secondary surgery after primary CELS resection
Conversion rate Intraoperative Conversion rate (%) from laparoscopic surgery to open surgery
Long-term oncological outcomes: Recurrence During 3-year follow-up periode Locoregional and/or distant recurrence after surgery defined as any histological, morphological, and clinical evidence of tumour growth during follow-up periode
Clavien-Dindo classification Within 90 days postoperative. Grading system used in surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures. Grade I to V, where V is death of the patient
Hospital readmissions Within 90 days postoperative. Unplanned readmissions that happen within 3 days of discharge from the index (i.e., initial) admission
Trial Locations
- Locations (3)
Hospital Soenderjylland
🇩🇰Aabenraa, Denmark
Copenhagen University Hospital - Herlev
🇩🇰Copenhagen, Herlev, Denmark
Zealand University Hospital
🇩🇰Køge, Denmark