- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01308489
Minimally Invasive Surgery in Treating Patients With Spinal Tumors
Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
Aperçu de l'étude
Statut
Les conditions
Description détaillée
PRIMARY OBJECTIVES:
I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.
SECONDARY OBJECTIVES:
I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo posterior spinal tumor resection on day 0.
ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.
After completion of study treatment, patients are followed up for 6 months.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Duarte, California, États-Unis, 91010
- City of Hope Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be undergoing any posterior spinal fusion with or without anterior fusion anywhere from occiput to sacrum
- Greater than 3 month life expectancy
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients who are not surgical candidates for spine tumor removal, determined by the surgical team
- Patients who have undergone previous spine surgery for tumor removal will be excluded
- Patients with renal cell carcinoma
- As there is an emphasis on blood loss and length of surgery, the critical variable for homogeneity is the vascularity of the tumor; hypervascular spine tumors are regarded by surgeons as amongst the most challenging of cases; by far the three most common hypervascular metastatic tumors are those arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies are usually regarded as a distinct subset for this reason in the majority of studies; because we rarely encounter the later two pathologies in our practice, we chose to include only the former; however, to further homogenize our study population we will exclude all three of the known hypervascular metastatic spine tumors
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Arm I (posterior spinal tumor resection)
Patients undergo posterior spinal tumor resection on day 0.
|
Etudes annexes
Autres noms:
Undergo posterior spinal tumor resection
Undergo anterior and posterior spinal tumor resection
|
Expérimental: Arm II (anterior and posterior spinal tumor resection)
Patients undergo anterior and posterior tumor resection on day 0.
|
Etudes annexes
Autres noms:
Undergo posterior spinal tumor resection
Undergo anterior and posterior spinal tumor resection
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Estimated blood loss (EBL); in milliliters (ml)
Délai: Day 0
|
Will be comparing means with the Wilcoxon test.
|
Day 0
|
Length of operation (OR time)
Délai: Day 0
|
Will be comparing means with the Wilcoxon test.
|
Day 0
|
Complication rate
Délai: Day 0
|
Day 0
|
|
Neurological preservation
Délai: Post operation day 90
|
Post operation day 90
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Length of stay
Délai: Less than 7 days
|
Less than 7 days
|
|
Pain symptoms
Délai: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
|
Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale
Délai: Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale
|
Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
Evaluation of arthrodesis
Délai: Post-op day 1, 28, and 90
|
Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery.
This is done to relieve intractable pain in a joint which cannot be managed by pain medication.
|
Post-op day 1, 28, and 90
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rahul Jandial, MD, City of Hope Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 10115 (DAIDS-ES)
- NCI-2011-00231 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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