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- Essai clinique NCT04198025
Psoas Density in Colorectal Cancer
Evaluating the Association Between Psoas Density Measurement on Preoperative CT Imaging and Postoperative Outcomes
Colorectal cancer (CRC) is the 3rd most common cancer worldwide. In the UK, CRC is the 4th most common cancer accounting for 12% of cancers diagnosed each year with approximately 41,300 new cases diagnosed in 2014. Surgery remains the only treatment option that can reliably achieve cure from colorectal cancer and thus nearly 20,000 major bowel resections are performed for this yearly in the UK. Surgery for these cancers however carries risk of major complications and potentially death. Selecting appropriate patients for surgery remains a challenge to cancer teams.
Risk factors exist for complications after surgery for CRC, many of which can be assessed and discussed with the patient prior to surgery, so that any decision to operate is with fully informed consent from the patient. Increasing attention is being paid to a patient's frailty or fitness as one of these risk factors. Our centre has previously shown that measuring the cross-sectional area of the psoas muscle (a large muscle near the spine) from preoperative imaging could predict major complications in colorectal cancer patients (Jones 2015), however specialist software and patient height is required to make this calculation. More recently we have demonstrated that the measurement of the psoas muscle density on preoperative imaging (i.e. routine CT scans that all patients have before surgery to plan treatment), may potentially be useful to predict which patients are at most risk of a major complication (Herrod 2019). If this finding holds true when tested on a larger scale, it could be used to help surgical teams make the decision on whether to offer surgical resection, what kind of operations to perform, how to best support individuals undergoing operation and to ensure that the patient has the most information available to decide what risk they are at by having major surgery.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Derbyshire
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Derby, Derbyshire, Royaume-Uni, DE22 3DT
- School of Graduate Entry Medicine, Royal Derby Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
Patient criteria:
- Having a major colorectal resection for the treatment of cancer
- Elective or emergency surgery
- Adults, defined as age ≥18 years of age (no maximum limit)
- Had a preoperative CT scan of the abdomen with contrast (portal venous phase)
- Operation performed between 31st Aug 2013 - 31st Aug 2019
Exclusion Criteria:
- Not having a preoperative CT scan with contrast
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Patients who underwent colorectal resection
Patients in this observational study will have undergone CT scan as routine work up prior to resection of elective colorectal cancer. Psoas muscle density will be measured (in Hounsfield units from CT images) at lumbar vertebral level L3. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of post operative complications (Clavien-Dindo grade 3-4) during inpatient hospital stay.
Délai: Through study completion, an average of 10 days.
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Recorded post operative complications requiring intervention during post operative stay until initial discharge from hospital.
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Through study completion, an average of 10 days.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Post operative length of stay
Délai: Through study completion, usually between 6-10 days.
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Number of days
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Through study completion, usually between 6-10 days.
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Mortality
Délai: Up to 5 year follow up from operation
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Recorded patient death
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Up to 5 year follow up from operation
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Post operative complications beyond hospital discharge.
Délai: From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).
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Recorded post operative complications (including re-operation or recurrence) until discharge from surgical clinic or date of record review.
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From hospital discharge to record review (i.e. 30 days, 90 days, 2 - 5 year follow up).
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Psoas Muscle Density
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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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