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

NCT ID: NCT02790203

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30

Brief Summary

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

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.

Conditions

Prevention of Post Operative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

NSAIDS

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Celecoxib

NSAIDS

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Nir Horesh resident Department of Surgery and Transplant

Resident in General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nir Horesh, Dr.

Role: CONTACT

horesh.nir@gmail.com

Other Identifiers

2913-16-SMC

Identifier Type: -

Identifier Source: org_study_id