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Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery (ABP-CS)

27 de junio de 2026 actualizado por: Jingyuan,Xu, Southeast University, China

Efficacy of an Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery: A Randomized Controlled Trial Using Quantitative Gastric Bubble Imaging Analysis

Postoperative gastric distension is a common gastrointestinal complication after cardiac surgery and may delay recovery, prolong intensive care unit (ICU) stay, and reduce patient comfort. Anti-bloating patches are widely used in clinical practice to promote gastrointestinal function recovery; however, high-quality evidence regarding their effectiveness in cardiac surgical patients remains limited.

This randomized controlled trial aims to evaluate the efficacy and safety of an anti-bloating patch in reducing postoperative gastric distension after cardiac surgery. Adult patients undergoing cardiac surgery will be randomly assigned to receive either standard perioperative care alone or standard perioperative care plus anti-bloating patch therapy. Gastric bubble area will be quantitatively measured using chest radiographs and image analysis software.

The primary outcome is the change in gastric bubble area on postoperative day 1 compared with baseline. Secondary outcomes include gastric bubble area on postoperative day 1, percentage change in gastric bubble area, abdominal distension score, time to first flatus, time to first bowel movement, gastric drainage volume, time to oral feeding, ICU length of stay, postoperative hospital length of stay, and patch-related adverse events.

The results of this study may provide evidence for the use of anti-bloating patches as an adjunctive intervention to enhance postoperative gastrointestinal recovery in patients undergoing cardiac surgery.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Background Postoperative gastrointestinal dysfunction is frequently observed after cardiac surgery because of surgical stress, cardiopulmonary bypass, anesthesia, opioid administration, and prolonged bed rest. Gastric distension may contribute to patient discomfort, delayed gastrointestinal recovery, prolonged hospitalization, and increased healthcare utilization. Although anti-bloating patches are commonly used as a complementary intervention in perioperative care, evidence regarding their efficacy in cardiac surgery patients remains insufficient.

Objective To evaluate the clinical efficacy and safety of anti-bloating patch therapy for postoperative gastric distension in patients undergoing cardiac surgery and to establish an objective imaging-based method for quantitative assessment of gastric bubble area.

Methods This is a prospective, randomized, controlled, single-center clinical trial. A total of 150 adult patients undergoing elective cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either an anti-bloating patch group or a control group.

Participants in the control group will receive standard perioperative management. Participants in the intervention group will receive anti-bloating patch therapy in addition to standard perioperative management.

Chest radiographs obtained on the day of surgery and on postoperative day 1 will be analyzed using ImageJ software. Gastric bubble area will be independently measured by trained investigators according to a predefined protocol

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

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

  • Nombre: Xu Jingyuan, Director
  • Número de teléfono: 025-83262550
  • Correo electrónico: zhongdacq804@126.com

Ubicaciones de estudio

  • Porcelana
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana
        • Zhongda Hospital, Southeast University
        • Contacto:

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:

  • Age ≥18 years
  • Undergoing elective cardiac surgery
  • Postoperative chest radiographs available for gastric bubble area assessment
  • Able to provide written informed consent or have consent provided by a legally authorized representative
  • Expected postoperative intensive care unit admission

Exclusion Criteria:

  • Previous major gastrointestinal surgery affecting gastric anatomy or motility
  • Known gastrointestinal obstruction, perforation, or severe gastrointestinal disease
  • Severe hepatic or renal dysfunction judged unsuitable by the investigators
  • Known allergy or hypersensitivity to components of the anti-bloating patch
  • Participation in another interventional clinical trial within the previous 30 days
  • Pregnancy or lactation
  • Inability to complete study assessments or follow study procedures

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: Anti-Bloating Patch Group
Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.
Otro: Anti-Bloating Patch
Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
Otro: Standard Perioperative Care
Standard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated.
Comparador activo: Control Group
Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment.
Otro: Standard Perioperative Care
Standard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Gastric Bubble Area on Postoperative Day 1
Periodo de tiempo: Postoperative Day 1
Change in gastric bubble area measured on chest radiographs from the day of surgery to postoperative day 1. Gastric bubble area will be quantified using ImageJ software and calculated as: postoperative day 1 gastric bubble area minus baseline gastric bubble area measured on the day of surgery.
Postoperative Day 1

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gastric Bubble Area on Postoperative Day 1
Periodo de tiempo: Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Postoperative Day 1
Percentage Change in Gastric Bubble Area
Periodo de tiempo: Postoperative Day 1
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Postoperative Day 1
Abdominal Distension Score
Periodo de tiempo: Postoperative Day 1
Patient-reported abdominal distension severity assessed using a Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no abdominal distension and 10 indicates the worst imaginable abdominal distension. Higher scores indicate more severe abdominal distension.
Postoperative Day 1
Time to First Flatus
Periodo de tiempo: From surgery until first flatus, up to hospital discharge
Time from completion of surgery to first passage of flatus.
From surgery until first flatus, up to hospital discharge
Time to First Bowel Movement
Periodo de tiempo: From surgery until first bowel movement, up to hospital discharge
Time from completion of surgery to first bowel movement.
From surgery until first bowel movement, up to hospital discharge
Gastric Drainage Volume
Periodo de tiempo: Within 24 hours after surgery
Total gastric drainage volume recorded during the first 24 postoperative hours.
Within 24 hours after surgery
Time to Oral Feeding
Periodo de tiempo: Through hospital discharge, an average of 10 days
Time from completion of surgery to first oral intake, measured in hours.
Through hospital discharge, an average of 10 days
Intensive Care Unit Length of Stay
Periodo de tiempo: Through ICU discharge, an average of 3 days
Duration of stay in the intensive care unit, measured in hours or days.
Through ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
Periodo de tiempo: Through hospital discharge, an average of 10 days
Duration of hospitalization after surgery, measured in days.
Through hospital discharge, an average of 10 days
Incidence of Patch-Related Adverse Events
Periodo de tiempo: From patch application through hospital discharge, an average of 10 days
Incidence of adverse events related to anti-bloating patch application, including skin irritation, rash, itching, allergic reactions, or other treatment-related adverse events.
From patch application through hospital discharge, an average of 10 days

Colaboradores e Investigadores

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

Patrocinador

Southeast University, China

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 (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de junio de 2026

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

27 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2026ZDSYLL231-P01

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 may be made available upon reasonable request to the corresponding investigator after publication of the primary study results, subject to institutional approval and applicable data protection regulations.

Marco de tiempo para compartir IPD

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and ending 5 years after publication.

Criterios de acceso compartido de IPD

Access to de-identified individual participant data, study protocol, statistical analysis plan, and informed consent form will be provided to qualified researchers whose proposed use of the data has been approved by the principal investigator and the sponsoring institution. Requests should include a methodologically sound research proposal. Data will be shared for the purpose of achieving the aims outlined in the approved proposal and in accordance with applicable ethical and data protection requirements.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

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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