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

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

Study Overview

• Status: Unknown
• Conditions: Prevention of Post Operative Ileus
• Intervention / Treatment: Drug: Placebo; Drug: Celecoxib

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nir Horesh, Dr.; Email: horesh.nir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celecoxib; 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; NSAIDS
Placebo Comparator: Placebo; 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; Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 22, 2016
• First Submitted That Met QC Criteria: May 29, 2016
• First Posted (Estimate): June 3, 2016

Study Record Updates

• Last Update Posted (Estimate): June 3, 2016
• Last Update Submitted That Met QC Criteria: May 29, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 2913-16-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED