- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01581905
Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
Approximately 600,000 women undergo hysterectomy each year in the United States, of which 12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has also shown the complication rates for laparoscopic cases are similar to open procedures in the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques are the technical obstacles of performing minimally invasive hysterectomies. Robotic technology has emerged as a means to decrease the learning curve and increase the availability of minimally invasive surgery to patients. A current review of the literature reveals no randomized trials evaluating the efficacy of conventional laparoscopic hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to address this void.
The primary objective of this study is to determine whether Robot-Assisted Laparoscopic Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to operative time, blood loss, and hospital stay. The investigator's secondary objective was to assess the cost, morbidity, and mortality of each procedure.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S. Hershey Medical Center
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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:
- Individuals recruited into this study will be patients presenting to the Urogynecology and Minimally Invasive Surgical Group for consultation for hysterectomy.
Exclusion Criteria:Individuals who are not candidates for laparoscopic surgery
- Medical Condition that does not allow pneumoperitoneum
- Medical Condition that does not allow proper ventilation during anesthesia
- Uterine size precluding access to the uterine artery
- Pelvic Organ Prolapse amendable to a vaginal approach
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: LH Group
The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.
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Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
Otros nombres:
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Comparador activo: RH Group
The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.
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Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Operating Time
Periodo de tiempo: Operating time is measured on the day of surgery after completing the procedure.
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Operating time is measured on the day of surgery after completing the procedure.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estimated Blood Loss
Periodo de tiempo: Estimated blood loss will be measured on the day of surgery after completing the procedure.
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Estimated blood loss will be measured on the day of surgery after completing the procedure.
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Intraoperative Complications
Periodo de tiempo: Intraoperative complications will be measured on the day of surgery after completing the procedure.
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Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage
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Intraoperative complications will be measured on the day of surgery after completing the procedure.
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Perioperative Complications
Periodo de tiempo: Perioperative complications will be measured on the date of discharge from the hospital.
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Perioperative complications include: urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE)
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Perioperative complications will be measured on the date of discharge from the hospital.
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Early Postoperative Complications
Periodo de tiempo: Early postoperative complications will be measured on the date of discharge from the hospital until two weeks after surgery, assessed up to 14 days post-operativley.
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Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)
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Early postoperative complications will be measured on the date of discharge from the hospital until two weeks after surgery, assessed up to 14 days post-operativley.
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Delayed Post-Operative Complications
Periodo de tiempo: Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.
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Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration
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Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.
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Costs
Periodo de tiempo: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.
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Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.
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Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Janis L Green, MD, Milton S. Hershey Medical Center
- Director de estudio: Gerald J Harkins, MD, Milton S. Hershey Medical Center
- Silla de estudio: Matthew Davies, MD, Milton S. Hershey Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr Opin Obstet Gynecol. 2011 Aug;23(4):283-8. doi: 10.1097/GCO.0b013e328348a26e.
- Pasic RP, Rizzo JA, Fang H, Ross S, Moore M, Gunnarsson C. Comparing robot-assisted with conventional laparoscopic hysterectomy: impact on cost and clinical outcomes. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):730-8. doi: 10.1016/j.jmig.2010.06.009. Epub 2010 Sep 17.
- Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. Epub 2008 Mar 6.
- Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
- Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (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
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias por tipo histológico
- Neoplasias
- Dolor
- Manifestaciones neurológicas
- Enfermedades uterinas
- Hemorragia
- Trastornos de la menstruación
- Neoplasias De Tejido Muscular
- Endometriosis
- Metrorragia
- Leiomioma
- Menorragia
- Dolor pélvico
- Hemorragia uterina
Otros números de identificación del estudio
- 38824
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