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Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

19 de enero de 2017 actualizado por: Milton S. Hershey Medical Center

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

Descripción detallada

See Above

Tipo de estudio

Intervencionista

Inscripción (Actual)

98

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Penn State Milton S. Hershey Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Comparador activo: LH Group
The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.
Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
Otros nombres:
  • LH Group
Comparador activo: RH Group
The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.
Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
Otros nombres:
  • RH Group

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Operating Time
Periodo de tiempo: Operating time is measured on the day of surgery after completing the procedure.
Operating time is measured on the day of surgery after completing the procedure.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Estimated Blood Loss
Periodo de tiempo: Estimated blood loss will be measured on the day of surgery after completing the procedure.
Estimated blood loss will be measured on the day of surgery after completing the procedure.
Intraoperative Complications
Periodo de tiempo: Intraoperative complications will be measured on the day of surgery after completing the procedure.
Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage
Intraoperative complications will be measured on the day of surgery after completing the procedure.
Perioperative Complications
Periodo de tiempo: Perioperative complications will be measured on the date of discharge from the hospital.
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)
Perioperative complications will be measured on the date of discharge from the hospital.
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.
Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)
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.
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.
Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration
Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.
Costs
Periodo de tiempo: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.
Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.
Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2012

Finalización primaria (Actual)

1 de marzo de 2013

Finalización del estudio (Actual)

1 de junio de 2013

Fechas de registro del estudio

Enviado por primera vez

24 de febrero de 2012

Primero enviado que cumplió con los criterios de control de calidad

18 de abril de 2012

Publicado por primera vez (Estimar)

20 de abril de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

19 de enero de 2017

Última verificación

1 de enero de 2017

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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