Patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. These patients often receive preoperative treatment before surgery. There is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. Removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects. This study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and QoL.
Patients with advanced rectal cancer will receive standard care, if lateral lymph nodes exist after neoadjuvant treatment they will be operated accordingly. The focus will be to compare two groups (with and without lateral lymph node clearance) regarding function, QoL and oncologic outcome. We will also aim to identify features on MRI to improve diagnostic ability.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, Sweden
Local recurrence
A tumour recurrence within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology
Time frame: Three years
Complications according to a composite outcome
Composite outcome including: * Comprehensive Complications index * Lymphedema (answer yes to questionnaire regarding swelling in right/left groin or leg) * Thrombosis (registration in CRF) and questionnaire
Time frame: 90 days
Lateral local recurrence
A tumour recurrence located in the lateral compartments within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology
Time frame: 3 years
Lateral local recurrence
A tumour recurrence located in the lateral compartments within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology
Time frame: 5 years
Surgical morbidity (including reoperations) (Clavien Dindo score I-V)
Clavien-Dindo IIIb and more measured as proportion
Time frame: 90 days
Surgical morbidity measured as Comprehensive Complications index (lower score = less complications)
All complications registered according to Clavien-Dindo using a calculator to identify a combination of the number and the severity of complications.
Time frame: 90 days
Perioperative blood loss
Blood loss during the surgical procedure: Registration in operative CRF (ml in suction + estimation by anaesthesiologist)
Time frame: 0-24 hours
Total operating time
Registration in operative CRF (op start and op end)
Time frame: 0-24 hours
Length of hospital stay
Total days in hospital including referral to other hospital
Time frame: during the first hospitalization until discharge after first surgery, measured within 3 months of the first surgical proceu
Total length of hospital stay
Total number of days including readmissions
Time frame: 365 days = 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Clinical or radiological or patient reported thromobsis
Time frame: 1 year
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Clinical or radiological or patient reported thromobsis
Time frame: 2 years
Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis)
Clinical or radiological or patient reported thromobsis
Time frame: 3 years
Health related Quality of life
Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.
Time frame: 1 month postop
Health related Quality of life
Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.
Time frame: 1 year
Health related Quality of life
Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.
Time frame: 2 years
Health related Quality of life
Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL.
Time frame: 3 years
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Time frame: 1 month
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Time frame: 1 year
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Time frame: 2 years
Urinary function
Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach.
Time frame: 3 years
Sexual function
Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.
Time frame: 1 year
Sexual function
Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.
Time frame: 2 years
Sexual function
Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach.
Time frame: 3 years
Bowel and stoma function
Measured in QoL questionnaire, major LARS (21-42 points)
Time frame: 1 year
Bowel and stoma function
Measured in QoL questionnaire, major LARS (21-42 points)
Time frame: 2 years
Bowel and stoma function
Measured in QoL questionnaire, major LARS (21-42 points)
Time frame: 3 years
Health economic analysis
A total health economic analysis including societal costs
Time frame: 1 year
Mortality
Dead by any cause
Time frame: 1 year
Mortality
Dead by any cause
Time frame: 2 years
Mortality
Dead by any cause
Time frame: 3 years
5- year overall survival
Survival at 5 years
Time frame: 5 years
Pain according to brief pain inventory
Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics
Time frame: 1 month
Pain according to brief pain inventory
Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics
Time frame: 1 year
Pain according to brief pain inventory
Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics
Time frame: 2 years
Pain according to brief pain inventory
Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics
Time frame: 3 years
MRI interobserver variability
Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment
Time frame: First month
MRI interobserver variability
Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment
Time frame: First 6 months
MRI vs pathology
Comparing MRI assessment with pathology report, diagnostic (pretreatment) and post treatment MRI compared with pathology report
Time frame: First 6 months
ctDNA at diagnosis
Value of ctDNA at diagnosis, the possible correlation with malignant lymph nodes
Time frame: Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence
Value of immunoscore to predict response, and presence of lateral lymph nodes
Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on MRI
Time frame: 1 month
Value of immunoscore to predict response, and presence of lateral lymph nodes
Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on pathology
Time frame: Perioperative biopsies (within 6 weeks from inclusion)
Evaluation dose/fraction in relation to response to treatment
Details from CRF during treatment planning as well as prospectively collected treatment plans
Time frame: Within the first 6 months.
Evaluation of number of fractions n relation to response to treatment
Details from CRF during treatment planning as well as prospectively collected treatment plans
Time frame: Within the first 6 months
Evaluation of final dose to tumor and elective LN volume
Details from CRF during treatment planning as well as prospectively collected treatment plans
Time frame: Within the first 6 months
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