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

NCT02790203 | Unknown

• 1 other identifier: 2913-16-SMC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prevention of Post Operative Ileus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reduction of post operative ileus (questionnaire)

  First week after surgery

• Post operative pain reduction (VAS score)

  First week after surgery

• Reduction of opoids consumption (registration of all medications)

  First month after surgery

• Post operative complication rate (patients follow up)

  First month after surgery

Study Arms (2)

Celecoxib

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Celecoxib DRUG

NSAIDS

Celecoxib

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Nir Horesh, Dr.

CONTACT

horesh.nir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in General Surgery

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: June 3, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Last Updated: June 3, 2016

Record last verified: 2016-05