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3D Versus 2D Laparoscopic Ovarian Cystectomy

4 de noviembre de 2019 actualizado por: Lui Man Wa, Queen Mary Hospital, Hong Kong

Comparison of Three-dimension Versus Two-dimension Laparoscopic Ovarian Cystectomy

This is a prospective randomized study involving 80 patients. All participates will be given written information on 3D laparoscopy. They will be randomized according to computer-generated random sequence into two groups, 2D and 3D group. The operation will then be performed either using 2D or 3D laparoscopy. Surgeons are allowed to change to the other type of laparoscopy if difficulty encountered. After the operation, the surgeons will be required to fill in a questionnaire self-evaluating the performance using Global rating scale component of the intraoperative assessment tool (GOALS), any discomfort encountered, any need for change of laparoscopy and their preference on the type of laparoscopy.

The level of complexity of the operation, duration of operation, blood loss and complications will be recorded.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Laparoscopy has greatly replaced laparotomy in most gynaecological operations including oncological procedures. Laparoscopic approach is the mainstay for ovarian cystectomy nowadays. However the loss of depth perception and dexterity remains the drawback of laparoscopy. With the development of robotic surgery, the three-dimension vision and presence of "wrist" motion allowed surgeon to perform more complicated operations in sophisticated manner. Expensive instruments and the need for prolonged time of setup restricted the extensive use of it. Having those considerations in mind, three-dimension (3D) laparoscopy is another possible alternative. With the advancement of technology in 3D vision, it may provide better precision especially in perception of depth and spatial orientation. Dizziness, nausea, headache and ocular fatique are occasional side effects in 3D surgery which created concerns of the surgeons.

There have been studies using standardized tasks shown that 3D laparoscopy will improve the performance in surgeon both objectively and subjectively especially when performing complex task. It was suggested to be able to fasten the learning curve for beginners. The operation time was shorter when laparoscopic cholecystectomy was performed using 3D imaging without any major complications encountered.

Yet evidence in the applicability and use in clinical service in gynaecological operations are still inadequate. The investigators would like to evaluate the difference of 2D versus 3D laparoscopic ovarian cystectomy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

83

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

      • Hong Kong, Hong Kong
        • Department of Obstetrics and Gynaecology, Queen Mary Hospital

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Planned for laparoscopic ovarian cystectomy
  • Willing and able to participate after the study has been explained
  • Those understand either Cantonese, Putonghua or English

Exclusion Criteria:

  • essential data are missing from the participants records making it impossible to judge treatment outcome.

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
Experimental: three dimension laparoscopy
This group of patients will have laparoscopic ovarian cystectomy performed using three-dimension laparoscopy. The procedure will be performed in usual manner.
Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.
Sin intervención: Two dimension laparoscopy
Two-dimension laparosocpy would be used in this group of patient. The procedure will be performed in usual manner.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Duration of Laparoscopic Ovarian Cystectomy
Periodo de tiempo: duration of operation, up to 120 minutes
The duration of laparoscopic ovarian cystectomy will be recorded. It is defined as from insertion of primary port insertion till completion of performance of ovarian cystectomy. The time required for specimen retrieval will not be included.
duration of operation, up to 120 minutes
Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score
Periodo de tiempo: During the operation, up to 120 minutes
Surgeons are required to fill in a questionnaire using GOALS. It involved seven aspects - depth perception, bimanual dexterity, efficiency, tissue handling, autonomy, sharpness and image resolution. Each aspects scored 0 to 5 with higher the value, better the performance. The sum of the 7 aspects were used in comparison between groups with a maximum score of 35.
During the operation, up to 120 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Surgeons Encountered Side Effects
Periodo de tiempo: during the operation, up to 120 minutes
Dizziness, nausea and ocular fatique are common side effects of 3D laparoscopy. The number of surgeons experienced discomfort will be reported and any additional discomfort will be recorded.
during the operation, up to 120 minutes
Preference of Surgeons
Periodo de tiempo: during the operation, up to 120 minutes
Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.
during the operation, up to 120 minutes
Need for Change of Instrument
Periodo de tiempo: during the operation, up to 120 minutes
The surgeons are allowed to switch from 3D laparoscopy to tranditional 2D laparoscopy if deemed necessary by the surgeons. The reason for switch of instrument will be recorded as well.
during the operation, up to 120 minutes
Total Blood Loss During Operation
Periodo de tiempo: during the operation, up to 120 minutes
The total amount of blood loss during operation was recorded.
during the operation, up to 120 minutes
Duration of Hospital Stay
Periodo de tiempo: Postoperative up to 6 weeks
The total duration of hospital stay was recorded.
Postoperative up to 6 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Man Wa Lui, MBBS, Queen Mary Hospital, The University of Hong Kong

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.

Publicaciones Generales

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 mayo de 2014

Finalización primaria (Actual)

1 de mayo de 2016

Finalización del estudio (Actual)

1 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2016

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2016

Publicado por primera vez (Estimar)

17 de mayo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de noviembre de 2019

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

4 de noviembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • UW 14-096

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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