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

Prevention of Post Operative Ileus Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02790203
• Other study ID #: 2913-16-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: May 22, 2016
• Last updated: May 29, 2016
• Start date: June 2016

Study information

• Verified date: May 2016
• Source: Sheba Medical Center
• Contact: Nir Horesh, Dr.
• Email: horesh.nir[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention of Post Operative Ileus

Intervention

Drug:
• Celecoxib
NSAIDS
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No