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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
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.
In this study standard resection of the colon will be performed according to complete mesocolic excision (CME) principles.
Copenhagen University Hospital - Herlev
Copenhagen, Herlev, Denmark
RECRUITINGHospital Soenderjylland
Aabenraa, Denmark
ACTIVE_NOT_RECRUITINGZealand University Hospital
Køge, Denmark
RECRUITINGChange 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.
Time frame: 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
Change in exercise capacity and physical condition
The 30 Second Sit to Stand Test. A measurement that assesses functional lower extremity strength in older adults. Test result is the number of times the participant comes to a full standing position in 30 seconds. Higher number of stands within 30 seconds means better result.
Time frame: 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
Six minutes' walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: Changes will be assessed repeatedly at basline, 3 months, 6 months, 1 year follow-up
Frailty questionnaire Geriatric 8 (G8)
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.
Time frame: Basline
Duration of surgery
Duration of surgery in minutes
Time frame: Intraoperative
Blood loss
Blood loss in ml
Time frame: Intraoperative
Intraoperative complications
Descriptive registration of intraoperative complications;
Time frame: Intraoperative
Conversion rate
Conversion rate (%) from laparoscopic surgery to open surgery
Time frame: Intraoperative
Rate of complete resection margin
R0 (tumor-free margin \>1 mm) corresponds to resection for cure or complete remission. R1 to microscopic residual tumor, R2 to macroscopic residual tumor.
Time frame: Postoperative day 14
Assessment of histopathological risk factors
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.
Time frame: Postoperative day 14
Long-term oncological outcomes: Disease-free survival
Time from surgery until the recurrence of disease or death
Time frame: During 3-year follow-up periode
Long-term oncological outcomes: Overall survival
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
Time frame: During 3-year follow-up periode
Long-term oncological outcomes: Recurrence
Locoregional and/or distant recurrence after surgery defined as any histological, morphological, and clinical evidence of tumour growth during follow-up periode
Time frame: During 3-year follow-up periode
Clavien-Dindo classification
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
Time frame: Within 90 days postoperative.
The Comprehensive Complication Index
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)
Time frame: Within 90 days postoperative.
Length of hospital stay
Clinical metric that measures the length of time in days elapsed between a patient's hospital admittance and discharge.
Time frame: Within 90 days postoperative.
90-day mortality
Death within 90 days after surgery, as either an inpatient or outpatient
Time frame: Within 90 days postoperative.
Hospital readmissions
Unplanned readmissions that happen within 3 days of discharge from the index (i.e., initial) admission
Time frame: Within 90 days postoperative.
Rate of secondary standard resection
Rate in percent of performed secondary surgery after primary CELS resection
Time frame: Within 90 days postoperative.
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