Pérdida de peso preoperatoria para la reconstrucción abierta de la pared abdominal
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-center, registry-based, parallel, randomized controlled trial with 1:1 allocation. The study will consist of 2 arms: an intensive 6-month medical weight loss program prior to open retromuscular ventral hernia repair compared to upfront surgery without required weight loss. The medical obesity intervention will be conducted by physicians, nurse practitioners, and dieticians specializing in weight loss medicine. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Benjamin T Miller, MD
- Número de teléfono: 216 406-8573
- Correo electrónico: millerb35@ccf.org
Copia de seguridad de contactos de estudio
- Nombre: Erika Schmidt, MD
- Número de teléfono: 2163723107
- Correo electrónico: schmide7@ccf.org
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Reclutamiento
- Northwestern University
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Contacto:
- Megan Melland-Smith, MD
- Número de teléfono: 312-907-1414
- Correo electrónico: megan.mellandsmith@nm.org
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Contacto:
- Nancy Ly, MD
- Número de teléfono: 262-455-1560
- Correo electrónico: nancy.ly@nm.org
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Investigador principal:
- Megan Melland-Smith, MD
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Reclutamiento
- Cleveland Clinic Main Campus
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Contacto:
- Benjamin T Miller, MD
- Número de teléfono: 2164068573
- Correo electrónico: millerb35@ccf.org
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-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria
- Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh
- BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.
Exclusion criteria
- Lack of English language fluency
- Urgent need for repair as determined by surgeon judgement
- Pregnant patients
- Permanent stoma in place
- Isolated flank hernia
- Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.
- BMI <40 or >55 kg/m2
- Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).
- Obstructive symptoms
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Sin intervención: Cirugía inicial
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Comparador activo: Programa de control de peso preoperatorio
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The medical obesity intervention is comprised of monthly visits with an obesity medicine (OM) provider +/- a registered dietitian (in person or virtual). Lifestyle modifications (nutrition, physical activity, stress, sleep), appetite control, and medication side effects will be addressed in all visits. At initial visit, patients will evaluated in person by an OM provider +/- registered dietitian. An individualized intense lifestyle intervention will be implemented with the addition of an anti-obesity medication (phentermine, naltrexone/bupropion, phentermine/topiramate, liraglutide, semaglutide, etc). Medication use will be based on disease risk, patient preference, severity of obesity, contraindications, potential drug interactions and insurance coverage. A diet recommendation will be tailored to the patient's medical and food allergy history. Weight and vital signs will be monitored at each visit. Participants will have a total of 5 follow-up monthly encounters, every 30 +/- 7 days. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Abdominal core health-specific quality of life at 1 year
Periodo de tiempo: 1 year
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This will be measured at 1 year using the HerQLes survey which is scored from 0-100 with higher scores indicating better quality of life. |
1 year
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hernia recurrence at 1 year
Periodo de tiempo: 1 year
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This will be based on based on the current consensus definition of hernia recurrence which considers CT scan reviewed by 3 blinded assessors, surgeon clinical exam, and patient-reported bulge. |
1 year
|
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Wound morbidity at 30 days
Periodo de tiempo: 30 days
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This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention. |
30 days
|
|
Wound morbidity at 1 year
Periodo de tiempo: 1 year
|
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention. |
1 year
|
|
Body composition changes in weight
Periodo de tiempo: 1 year
|
This includes comparative mean changes in body weight (kg) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up. |
1 year
|
|
Body composition changes in BMI
Periodo de tiempo: 1 year
|
This includes comparative mean changes in BMI (kg/m2) between groups from time of enrollment, day of surgery, 30-day follow-up, and 1-year follow-up. |
1 year
|
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Patient abdominal wall specific- quality of life with preoperative weight management program
Periodo de tiempo: 1 year
|
This includes difference in abdominal wall-specific quality of life using the HerQLes score (0-100 with higher scores indicating better abdominal wall-specific quality of life) in the weight loss arm before and after weight loss intervention. |
1 year
|
|
Patient-reported pain changes with preoperative weight management program
Periodo de tiempo: 1 year
|
This includes difference in pain using the PROMIS 3a Pain Intensity Score (30.7-71.8 with higher scores indicating more pain) in the weight loss arm before and after weight loss intervention. |
1 year
|
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Patient-reported quality of life changes with preoperative weight management program
Periodo de tiempo: 1 year
|
This includes difference in overall quality of life using the EQ5D-5L with VAS (scored with an index value and a 0-100 score with higher scores indicating better quality of life) in the weight loss arm before and after weight loss intervention. |
1 year
|
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Abdominal wall -specific quality of life short-term
Periodo de tiempo: 30 days
|
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively. |
30 days
|
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Pain scores
Periodo de tiempo: 1 year
|
This includes the difference in pain scores using the PROMIS 3a Pain Intensity Score (scored from 30.7-71.8) at baseline, 30-day, and 1 year. |
1 year
|
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Cost effective analysis
Periodo de tiempo: 1 year
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Perform a formal cost effectiveness analysis. |
1 year
|
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Body weight percentage loss
Periodo de tiempo: 1 year
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Proportion of patients achieving a reduction in 5% and 10% body weight at end of 6-month medical weight loss intervention, day of surgery, and 1-year follow-up |
1 year
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Weight management program adherence
Periodo de tiempo: 1 year
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Proportion of successful completion of the program (defined as attending at least 4 visits) is associated with lower wound complications, hernia recurrence, or higher HerQLes score at one year |
1 year
|
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Impact of 10% body weight loss on wound complications
Periodo de tiempo: 1 year
|
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare proportion of wound complications |
1 year
|
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Impact of 10% body weight loss on hernia recurrence
Periodo de tiempo: 1 year
|
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare hernia recurrence at one year |
1 year
|
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Impact of 10% body weight loss
Periodo de tiempo: 1 year
|
For patients with weight loss of 10% body weight prior to surgery compared to no weight loss prior to surgery - compare HerQLes score (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year |
1 year
|
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Urgent repair
Periodo de tiempo: 1 year
|
Number of patients who require urgent hernia repair in either arm |
1 year
|
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Bariatric surgery prior to hernia repair and wounds
Periodo de tiempo: 1 year
|
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of wound complications at one year |
1 year
|
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Bariatric surgery prior to hernia repair and hernia recurrence
Periodo de tiempo: 1 year
|
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair, to evaluate rates of hernia recurrence at one year |
1 year
|
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Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
Periodo de tiempo: 1 year
|
Number of patients who opt for bariatric surgery and, for those patients that undergo hernia repair and HerQLes scores (0-100 with higher scores indicating better abdominal wall specific- quality of life) at one year |
1 year
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Benjamin T Miller, MD, The Cleveland Clinic
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 23-418
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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