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Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer

16 de julio de 2026 actualizado por: Mahmut Yassa

Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery.

The main questions it aims to answer are:

  • Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema?
  • Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view?
  • Does either bowel preparation method cause more discomfort or side effects before surgery?

Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery.

Participants will:

  • Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery.
  • Undergo standard laparoscopic surgery for endometrial cancer.
  • Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Adequate bowel preparation is important for achieving optimal surgical exposure during laparoscopic surgery for endometrial cancer. Inadequate bowel preparation may impair visualization of the operative field, requiring steeper Trendelenburg positioning and higher pneumoperitoneum pressures, which may increase the physiological burden of surgery and affect operative performance.

Mechanical bowel preparation with rectal enema is commonly used before gynecologic surgery, although its routine use remains controversial because evidence supporting its clinical benefit is limited. A standardized 3-day bowel preparation protocol may improve patient tolerance while maintaining adequate surgical conditions. However, prospective randomized studies comparing these two approaches specifically in laparoscopic endometrial cancer surgery remain limited.

This prospective randomized controlled trial will compare a standardized 3-day bowel preparation protocol with a preoperative rectal enema before laparoscopic surgery for endometrial cancer. The primary objective is to determine whether the dietary bowel preparation protocol can provide surgical conditions comparable to those achieved with rectal enema.

In addition to subjective assessment of surgical exposure, the study will evaluate objective intraoperative parameters, including the minimum Trendelenburg position and the minimum pneumoperitoneum pressure required to maintain an adequate surgical view. Operative outcomes, postoperative recovery, patient tolerance of the bowel preparation methods, and bowel preparation-related symptoms will also be evaluated.

The findings of this study may help optimize preoperative bowel preparation strategies, reduce unnecessary patient burden, and support evidence-based perioperative care for patients undergoing laparoscopic surgery for endometrial cancer.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

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.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
      • Istanbul, Turquía (Türkiye)
        • Reclutamiento
        • Başakşehir Çam and Sakura City Hospital
        • Contacto:
        • Sub-Investigador:
          • Bora Taşpınar, MD

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Female participants aged 18 to 90 years.
  • Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Planned open (abdominal) surgery.
  • Known allergy or contraindication to sodium phosphate rectal enema.
  • Age over 90 years.
  • Refusal or inability to provide written informed consent.

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Low-Residue Diet
Participants will follow a standardized 3-day bowel preparation protocol before surgery. The protocol includes a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery
Conductual: Low-Residue Diet
Participants will follow a standardized 3-day bowel preparation protocol consisting of a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery, with adequate hydration throughout the preparation period.
Comparador activo: Rectal Enema
Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol
Droga: Sodium Phosphate Rectal Enema
Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the manufacturer's instructions and the institutional bowel preparation protocol.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intraoperative Visual Index Score
Periodo de tiempo: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Surgical exposure will be assessed intraoperatively using the Visual Index score after establishment of pneumoperitoneum and placement of the camera trocar and one lateral ancillary trocar. The score ranges from 0 to 2, where 0 indicates inadequate visualization despite bowel retraction with one grasper, 1 indicates adequate visualization requiring bowel retraction with one grasper, and 2 indicates adequate visualization without bowel retraction. Higher scores indicate better surgical exposure.
Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Minimum Trendelenburg Position Required for Adequate Surgical Exposure
Periodo de tiempo: Intraoperatively
The minimum Trendelenburg angle (degrees) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Intraoperatively
Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure
Periodo de tiempo: Intraoperatively
The minimum pneumoperitoneum pressure (mmHg) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Intraoperatively

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Operative Time
Periodo de tiempo: During surgery
Total operative time measured from skin incision to skin closure, recorded in minutes.
During surgery
Length of Hospital Stay
Periodo de tiempo: At hospital discharge, assessed up to 30 days after surgery
Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
At hospital discharge, assessed up to 30 days after surgery
Time to First Flatus
Periodo de tiempo: From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days
Time from completion of surgery to the first documented passage of flatus, measured in hours. The occurrence and timing of first flatus will be assessed during daily postoperative visits until the event occurs or until hospital discharge.
From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days
Patient Tolerance of Bowel Preparation
Periodo de tiempo: From preoperative bowel preparation until postoperative day 1
Patient tolerance will be assessed using completion of the assigned bowel preparation protocol, willingness to repeat the same preparation method in a future surgery, postoperative pain score, and bowel preparation-related symptoms. Symptoms will include nausea, overall discomfort, headache, insomnia, thirst, abdominal cramps, weakness, and fatigue, each assessed using a 0-10 numeric rating scale, where 0 indicates no symptom and 10 indicates the worst possible symptom.
From preoperative bowel preparation until postoperative day 1

Colaboradores e Investigadores

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

Patrocinador

Mahmut Yassa

Investigadores

  • Investigador principal: MAHMUT YASSA, MD, Başakşehir Çam & Sakura City Hospital

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 (Actual)

15 de julio de 2026

Finalización primaria (Estimado)

15 de enero de 2028

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

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

16 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ENDO-DIET-RCT-2026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.

Marco de tiempo para compartir IPD

Beginning 6 months after publication of the primary study results and ending 3 years after publication.

Criterios de acceso compartido de IPD

Access will be considered for qualified researchers conducting scientifically sound research. Requests must include a research proposal and, where appropriate, a statistical analysis plan. All requests will be reviewed by the principal investigator and approved according to institutional policies. Approved researchers will be required to sign a data use agreement before receiving de-identified data.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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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