Clinical trial NCT02790203: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevention of Post Operative Ileus
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: First flatus/bowel movement (questionnaire)
timeFrame: 48 to 72 hours after surgery
Secondary outcomes:
measure: Reduction of post operative ileus (questionnaire)
timeFrame: First week after surgery
measure: Post operative pain reduction (VAS score)
timeFrame: First week after surgery
measure: Reduction of opoids consumption (registration of all medications)
timeFrame: First month after surgery
measure: Post operative complication rate (patients follow up)
timeFrame: First month after surgery
Other outcomes:
Locations:
Study officials:
References: