Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-01 @ 3:23 PM
Study NCT ID:
NCT02790203
Status:
UNKNOWN
Last Update Posted:
2016-06-03
First Post:
2016-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'lastUpdateSubmitDate': '2016-05-29', 'studyFirstSubmitDate': '2016-05-22', 'studyFirstSubmitQcDate': '2016-05-29', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First flatus/bowel movement (questionnaire)', 'timeFrame': '48 to 72 hours after surgery', 'description': 'Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery.'}], 'secondaryOutcomes': [{'measure': 'Reduction of post operative ileus (questionnaire)', 'timeFrame': 'First week after surgery', 'description': 'Reduction of post-operative ileus rate in patients following colorectal surgery, treated with Celecoxib when compared with patients treated with placebo.'}, {'measure': 'Post operative pain reduction (VAS score)', 'timeFrame': 'First week after surgery', 'description': 'Post-operative pain reduction quality in patients treated with Celecoxib when compared with patients treated with placebo following surgery.'}, {'measure': 'Reduction of opoids consumption (registration of all medications)', 'timeFrame': 'First month after surgery', 'description': 'Reduction the amount of opioids consumed in patients treated with Celecoxib when compared with patients treated with placebo following surgery.'}, {'measure': 'Post operative complication rate (patients follow up)', 'timeFrame': 'First month after surgery', 'description': 'Post-operative complication rate, more specifically the rate of anastomotic leakage in patients treated with Celecoxib compared with patients treated with placebo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prevention of Post Operative Ileus']}, 'descriptionModule': {'briefSummary': 'Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after elective colonic resection.', 'detailedDescription': "Post-operative ileus is a common surgical complication occurring in with up to 20% of patients, with a significant clinical and economical effect.\n\nMany preventative measures have been tested to promote gastrointestinal motility following intestinal surgery have been suggested.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the age of 18 and 80\n* Patients planned for elective colorectal surgery with primary anastomosis\n* ASA score of 1-3\n* Patients that are able to sign an informed consent and comply with the protocol\n\nExclusion Criteria:\n\n* Patients with inflammatory bowel disease\n* Patients that require emergency surgery\n* Patients with renal failure, measured by Creatinine level \\> 1.5 mg/dL (\\>106.1 micro mol/l)\n* Patients with significant liver failure (known cirrhosis, Bilirubin level\\>2 mg/dL or 34.2 µmol/L)\n* Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group.\n* Patients treated chronically with any type of COX inhibitor.\n* Patients treated with NSAIDS including Aspirin 7 days prior to the date of surgery.\n* Patients with active peptic disease\n* Patient expected to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics or neuroleptics in the postoperative period\n* Patient with dysphagia or that have a difficulty swallowing capsules or tablets, or is unable to tolerate oral medication\n* Pregnant / lactating women.\n* Patients participating in any other interventional clinical trial'}, 'identificationModule': {'nctId': 'NCT02790203', 'briefTitle': 'Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'orgStudyIdInfo': {'id': '2913-16-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib', '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.\n\nCelecoxib 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.', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', '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.\n\nPlacebo will be given throughout the intervention period of the study orally in capsules that resemble the drug, twice a day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'description': 'NSAIDS', 'armGroupLabels': ['Celecoxib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nir Horesh, Dr.', 'role': 'CONTACT', 'email': 'horesh.nir@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in General Surgery', 'investigatorFullName': 'Dr. Nir Horesh resident Department of Surgery and Transplant', 'investigatorAffiliation': 'Sheba Medical Center'}}}}