Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain

Study Overview
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Brief Summary
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Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after elective colonic resection.

Detailed Description
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Post-operative ileus is a common surgical complication occurring in with up to 20% of patients, with a significant clinical and economical effect. Many preventative measures have been tested to promote gastrointestinal motility following intestinal surgery have been suggested. The medical intervention in the proposed study includes administration of a selective COX-2 inhibitor, specifically Celecoxib, in the peri-operative period following an elective colon resection. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic therapeutic effects. The drug is approved for use in by the ministry of health in Israel and in the United states. The study aims to assess the use of this widely used medication for evaluation of the clinical effect on post-operative bowel transit, as well as the drugs' effect on post-operative pain.

Conditions
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Prevention of Post Operative Ileus

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the age of 18 and 80 Patients planned for elective colorectal surgery with primary anastomosis ASA score of 1-3 Patients that are able to sign an informed consent and comply with the protocol Exclusion Criteria: Patients with inflammatory bowel disease Patients that require emergency surgery Patients with renal failure, measured by Creatinine level > 1.5 mg/dL (>106.1 micro mol/l) Patients with significant liver failure (known cirrhosis, Bilirubin level>2 mg/dL or 34.2 µmol/L) Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group. Patients treated chronically with any type of COX inhibitor. Patients treated with NSAIDS including Aspirin 7 days prior to the date of surgery. Patients with active peptic disease Patient expected to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics or neuroleptics in the postoperative period Patient with dysphagia or that have a difficulty swallowing capsules or tablets, or is unable to tolerate oral medication Pregnant / lactating women. Patients participating in any other interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Celecoxib will be given orally to patients participating in the study and allocated to the treatment group, for an intervention period of 6 days, starting from the day of surgery. Celecoxib will be given throughout the intervention period of the study orally at a dose of 400 mg per day divided into two doses, a dose which is within the recommended and a widely used dosage and is expected to induce a significant inhibition of prostaglandin synthesis by the COX2 pathway. Celecoxib will be given throughout the intervention period of the study orally at a dose of 400 mg per day divided into two doses. | Drug: Celecoxib<br>* NSAIDS<br>|
| Placebo Comparator: Placebo<br>Placebo will be given orally to patients participating in the study and allocated to the control group that will receive placebo, for an intervention period of 6 days, starting from the day of surgery. Placebo will be given throughout the intervention period of the study orally in capsules that resemble the drug, twice a day. | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First flatus/bowel movement (questionnaire) | Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery. | 48 to 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of post operative ileus (questionnaire) | Reduction of post-operative ileus rate in patients following colorectal surgery, treated with Celecoxib when compared with patients treated with placebo. | First week after surgery | 
| Post operative pain reduction (VAS score) | Post-operative pain reduction quality in patients treated with Celecoxib when compared with patients treated with placebo following surgery. | First week after surgery | 
| Reduction of opoids consumption (registration of all medications) | Reduction the amount of opioids consumed in patients treated with Celecoxib when compared with patients treated with placebo following surgery. | First month after surgery | 
| Post operative complication rate (patients follow up) | Post-operative complication rate, more specifically the rate of anastomotic leakage in patients treated with Celecoxib compared with patients treated with placebo. | First month after surgery |