Both study medications will be given orally for an intervention phase of 20 days as follows. Etodolac:400mg PO bid for the entire intervention period, Propranolol (slow release): 20 mg PO b.i.d. for 5 preoperative days; 80 mg PO b.i.d. on the day of surgery; 40 mg PO b.i.d. for the first post-operative week and 20 mg PO b.i.d. for the second post-operative week.

Same schedule as in the active comparator arm

Colorectal Neoplasms

Propranolol and etodolac

Placebo

HaEmek Medical Center

Rambam Health Care Campus

Rabin Medical Center

Sourasky Medical Center

Sheba Medical Center

Asaf Harofeh Medical Center

Colorectal Metastasis Prevention International Trial 2

Perioperative Use of a β-adrenergic Blocker, Propranolol, and a COX2 Inhibitor, Etodolac, in Patients Undergoing Resection With Curative Intent for Primary Colon and Rectal Cancer: Effect on Tumor Recurrence and Survival

Data regrading post-surgical recurrence will be recorded at 1,3,6,12,18,24,36,48, and 60 following surgery. Primary outcome 1 will be rate of recurrence/disease at 60 months.

Epithelial-to-mesenchymal-transition ( EMT) status and natural-killer cell, macrophage, T-cell, and B-cell infiltration levels into tumor tissue (as assessed by messenger RNA profiling of tissue samples

Cytokine levels in blood samples (interleukin-6, interleukin-10, C-reactive protein, interferon-gamma, and vascular endothelial growth factor and additional exploratory analysis of other cytokines)

According to the Clavien-Dindo classification system (7 grades of events depicting the severity of the event)

Assessed by changes on the brief symptom inventory 18 questionnaire (this questionnaire assess all three scales for depression, anxiety and global distress)

4 items related to fatigue in the 36 item short-form survey questionnaire.

Assaf-Harofeh Medical Center

Tel-Aviv Sourasky Medical Center

HaEmek Medical Center, Israel

Both study medications will be given orally for an intervention phase of 35 days as follows. Etodolac:400mg PO bid for the entire intervention period,Propranolol:20 mg PO bid for 5 preoperative days, 80 mg PO bid on the day of surgery and the following morning, 40 mg PO bid for following 6.5 days, and 20 mg PO bid for next 22 days.

Pancreatic Neoplasms

Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery

Perioperative Use of a Beta-adrenergic Blocker and a COX-2 Inhibitor in Patients Undergoing Surgery With Primary Pancreatic Cancer: Intervention Aiming to Reduce Pro-metastatic Processes

Data regrading post-surgical recurrence will be recorded at 1,3,6,12,18,24,36,48, and 60 following surgery

Epithelial-to-mesenchymal-transition ( EMT) status and natural-killer cell, macrophage, T-cell, and B-cell infiltration levels into tumor tissue (as assessed by messenger RNA profiling of tissue samples.

R-Pilot® was operated by an endomotor (VDW Silver, Munich, Germany) at "Reciproc All" setting.

ProGlider® was operated by an endodontic motor (X-Smart, Dentsply Sirona, Ballaigues, Switzerland) with 16:1 contra angle at the suggested settings (300 rpm on display, 5 Ncm).

In the manual glide path group, glide path creation was performed with stainless steel #08, 10, 15 K-files used with "push and pull" motion. Instruments were used with a motion in which the instrument proceeds apically quarterly to the point of resistance, then is pulled out for debris removal. The procedure was repeated with each file until the working length was achieved and confirmed with an electronic apex locator (Root ZX Mini, Morita Corp., Kyoto, Japan).

Postoperative Pain

Glide path preparation using R-Pilot® in reciprocating manner.

R-Pilot®

Glide path preparation using ProGlider® in a rotating manner.

ProGlider®

Glide path preparation using manual K-files numbered from 08 to 15.

Manual preparation

Ondokuz Mayıs University

Incidence of Postoperative Pain After Glide Path Preparation Using Three Different Instruments

Comparison of the Incidence of Postoperative Pain After Glide Path Preparation Using Manual, Reciprocating and Continuous Rotary Instruments: A Randomized Clinical Trial

VAS is a measure of pain intensity. In the present study, the VAS included a 10 cm straight horizontal line numbered at each centimetre from 0 to 10 showing two extreme symptoms of pain. "0" means no pain and "10" means the worst pain the subject has ever experienced. Each centimeter represents the pain intensity that the subject will mark orientated from 0 to 10. The intensity is increased from 0 to 10, therefore a higher score means a higher pain intensity. There are no subscales.

Cangül Keskin

Principal Investigator

Oligofructose (FOS, BioCare Ltd, Birmingham, England) powder will be distributed in sachets of 10 g. Two sachets are to be included in daily nutrition, preferentially 10 g diluted in water at breakfast and before supper.

adrenaline/väsimus

Colorectal Metastasis Prevention International Trial 2

Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery

Incidence of Postoperative Pain After Glide Path Preparation Using Three Different Instruments

Idiopathic Reactive Hypoglycaemia and Treatment With Fructo-Oligosaccharide

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