Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Celecoxib
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. |
NSAIDS
|
|
Comparatore placebo: Placebo
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. |
Placebo
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
First flatus/bowel movement (questionnaire)
Lasso di tempo: 48 to 72 hours after surgery
|
Reduction of time for first flatus/bowel movement from 48 hours to 72 hours in average following surgery.
|
48 to 72 hours after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reduction of post operative ileus (questionnaire)
Lasso di tempo: First week after surgery
|
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
|
|
Post operative pain reduction (VAS score)
Lasso di tempo: First week after surgery
|
Post-operative pain reduction quality in patients treated with Celecoxib when compared with patients treated with placebo following surgery.
|
First week after surgery
|
|
Reduction of opoids consumption (registration of all medications)
Lasso di tempo: First month after surgery
|
Reduction the amount of opioids consumed in patients treated with Celecoxib when compared with patients treated with placebo following surgery.
|
First month after surgery
|
|
Post operative complication rate (patients follow up)
Lasso di tempo: First month after surgery
|
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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Inibitori della ciclossigenasi
- Inibitori della cicloossigenasi 2
- Celecoxib
Altri numeri di identificazione dello studio
- 2913-16-SMC
Piano per i dati dei singoli partecipanti (IPD)
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