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

Sheba Medical Center

Status: Unknown

Conditions: Prevention of Post Operative Ileus

Treatments: Drug: Celecoxib; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02790203

2913-16-SMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Celecoxib

Experimental group

Description:

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.

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo