Perioperative Use of a Selective COX2 Inhibitor in Patients Undergoing Elective Colorectal Surgery: the Effect on Post-operative Bowel Motility and Post-operative Pain
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
|
|
Comparador de placebos: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First flatus/bowel movement (questionnaire)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction of post operative ileus (questionnaire)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Inhibidores de la ciclooxigenasa
- Inhibidores de la ciclooxigenasa 2
- Celecoxib
Otros números de identificación del estudio
- 2913-16-SMC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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