- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01639170
Abdominal Free Air After Surgery
Intra-abdominal Free Air on a Plain Radiograph After Surgery. Could it be a Finding That May Predict Gastrointestinal Perforation?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Naples, Italia, 80131
- Reclutamiento
- "Federico II" University
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Contacto:
- Francesco Milone, Prof.
- Número de teléfono: 00390817463067
- Correo electrónico: milone.marco@alice.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Abdominal surgery and major symptoms and signs suggestive of gastrointestinal perforation within the third postoperative day.
Exclusion Criteria:
- inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: subjects undergoing abdominal surgery
Subjects who undergone abdominal intervention and reported major symptoms and signs suggestive of gastrointestinal perforation (abdominal pain, leukocytosis, fever) within the third postoperative day. Exclusion criteria: inability to consent to the study, age ≤18 yr, certain or probable pregnancy, inability to remain in upright position for more than 10 minutes. |
All enrolled patients underwent erect chest x-rays assessment. In all cases the diagnosis of pneumoperitoneum was based upon the plain film identification of subdiaphragmatic air on the upright posteroanterior chest radiograph. All patients were transported from their hospital rooms to the radiology department in wheelchairs and remained in an upright position for more than 10 min before the chest radiographs were obtained. In all cases upright posteroanterior was obtained with the patient standing, using 183-cm distance, 125 kVp, phototimed exposure, and radiographic film with a wide exposure latitude. The disappearance of intraabdominal free gas will be evaluated every 48h and will be defined as the loss of the |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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prediction of gastrointestinal perforation
Periodo de tiempo: Within 3 days from surgery
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• Prediction of the presence of gastrointestinal perforation by the finding of intra-abdominal free air on a chest radiograph after abdominal surgery
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Within 3 days from surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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time taken for the absorption of intra-abdominal free air
Periodo de tiempo: within 3 days from surgery
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The evaluation of time taken for the absorption of intra-abominal free air and its correlation with age, sex, body mass index, previous surgery, operative time, type of surgery and use of peritoneal drainage tubes. The disappearance of intra-abdominal free gas was defined as the loss of the gas bubble under the domes of the hemidiaphragms on an erect chest radiograph |
within 3 days from surgery
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Tang CL, Yeong KY, Nyam DC, Eu KW, Ho YH, Leong AF, Tsang CB, Seow-Choen F. Postoperative intra-abdominal free gas after open colorectal resection. Dis Colon Rectum. 2000 Aug;43(8):1116-20. doi: 10.1007/BF02236559.
- Hope WW, Heniford BT, Norton HJ, Lincourt AE, Teigland CM, Kercher KW. Duration and clinical significance of radiographically detected "free air" after laparoscopic nephrectomy. Surg Laparosc Endosc Percutan Tech. 2009 Oct;19(5):415-8. doi: 10.1097/SLE.0b013e3181b6bff3.
- BRYANT LR, WIOT JF, KLOECKER RJ. A STUDY OF THE FACTORS AFFECTING THE INCIDENCE AND DURATION OF POSTOPERATIVE PNEUMOPERITONEUM. Surg Gynecol Obstet. 1963 Aug;117:145-50. No abstract available.
- Nielsen KT, Lund L, Larsen LP, Knudsen P. Duration of postoperative pneumoperitoneum. Eur J Surg. 1997 Jul;163(7):501-3. Erratum In: Eur J Surg 1997 Nov;163(11):880.
- Gayer G, Jonas T, Apter S, Amitai M, Shabtai M, Hertz M. Postoperative pneumoperitoneum as detected by CT: prevalence, duration, and relevant factors affecting its possible significance. Abdom Imaging. 2000 May-Jun;25(3):301-5. doi: 10.1007/s002610000036.
- Schauer PR, Page CP, Ghiatas AA, Miller JE, Schwesinger WH, Sirinek KR. Incidence and significance of subdiaphragmatic air following laparoscopic cholecystectomy. Am Surg. 1997 Feb;63(2):132-6.
- Millitz K, Moote DJ, Sparrow RK, Girotti MJ, Holliday RL, McLarty TD. Pneumoperitoneum after laparoscopic cholecystectomy: frequency and duration as seen on upright chest radiographs. AJR Am J Roentgenol. 1994 Oct;163(4):837-9. doi: 10.2214/ajr.163.4.8092019.
- Earls JP, Dachman AH, Colon E, Garrett MG, Molloy M. Prevalence and duration of postoperative pneumoperitoneum: sensitivity of CT vs left lateral decubitus radiography. AJR Am J Roentgenol. 1993 Oct;161(4):781-5. doi: 10.2214/ajr.161.4.8372757.
- Milone M, Di Minno MN, Bifulco G, Maietta P, Sosa Fernandez LM, Musella M, Iaccarino V, Buccelli C, Nappi C, Milone F. Diagnostic value of abdominal free air detection on a plain chest radiograph in the early postoperative period: a prospective study in 648 consecutive patients who have undergone abdominal surgery. J Gastrointest Surg. 2013 Sep;17(9):1673-82. doi: 10.1007/s11605-013-2282-6. Epub 2013 Jul 20.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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
Palabras clave
Otros números de identificación del estudio
- Federico II-0919
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