Prevention of Post Operative IleusNCT02790203
Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain
A study testing Celecoxib in people with Prevention of Post Operative Ileus, run by Sheba Medical Center.
Trial summary
Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after elective colonic resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prevention of Post Operative Ileus
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet.
Nir Horesh, Dr. contact
About this study
Perioperative Celecoxib to promote bowel movement and to reduce post-operative pain after elective colonic resection.
Read the 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.
- Conditions
- Prevention of Post Operative Ileus
- Being tested
- Celecoxib, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
NSAIDS
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First flatus/bowel movement (questionnaire)
Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery.
Measured: 48 to 72 hours after surgery
Secondary outcomes (4)
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.
Measured: First week after surgery
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.
Measured: First week after surgery
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.
Measured: First month after surgery
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.
Measured: First month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Post Operative IleusStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Nir Horesh resident Department of Surgery and Transplant, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790203
- Sponsor's protocol ID
- 2913-16-SMC
- Status last verified
- May 2016
- First submitted
- 22 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02790203
- Acronym / sponsor ID
- 2913-16-SMC
- Conditions
- Prevention of Post Operative Ileus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibCelecoxib 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibNSAIDS | Drug | Celecoxib |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
First flatus/bowel movement (questionnaire)
Time frame: 48 to 72 hours after surgery
Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery.
4 secondary outcomes
Reduction of post operative ileus (questionnaire)
Time frame: First week after surgery
Post operative pain reduction (VAS score)
Time frame: First week after surgery
Reduction of opoids consumption (registration of all medications)
Time frame: First month after surgery
Post operative complication rate (patients follow up)
Time frame: First month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nir Horesh, Dr. contact
Questions about this trial
What is this clinical trial studying?
A study testing Celecoxib in people with Prevention of Post Operative Ileus, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nir Horesh, Dr. (horesh.nir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First flatus/bowel movement (questionnaire) (time frame: 48 to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.