Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Abdominal Wall Hernia
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 258 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Upfront Surgery
No informado en este registro.
Preoperative Weight Management Program
No informado en este registro.
Other: Preoperative Weight Management Program
Preoperative Weight Management Program OTHER
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 evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Abdominal core health-specific quality of life at 1 year
Plazo: 1 year
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.
Medidas secundarias
Hernia recurrence at 1 year
Plazo: 1 year
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.
Wound morbidity at 30 days
Plazo: 30 days
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Wound morbidity at 1 year
Plazo: 1 year
This includes including surgical site infection, surgical site occurrence, and surgical site occurrence requiring procedural intervention.
Body composition changes in weight
Plazo: 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.
Body composition changes in BMI
Plazo: 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.
Patient abdominal wall specific- quality of life with preoperative weight management program
Plazo: 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.
Patient-reported pain changes with preoperative weight management program
Plazo: 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.
Patient-reported quality of life changes with preoperative weight management program
Plazo: 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.
Abdominal wall -specific quality of life short-term
Plazo: 30 days
This includes difference in abdominal wall -specific quality of life using the HerQLes score between groups at baseline and 30 days postoperatively.
Pain scores
Plazo: 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.
Cost effective analysis
Plazo: 1 year
Perform a formal cost effectiveness analysis.
Body weight percentage loss
Plazo: 1 year
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
Weight management program adherence
Plazo: 1 year
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
Impact of 10% body weight loss on wound complications
Plazo: 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
Impact of 10% body weight loss on hernia recurrence
Plazo: 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
Impact of 10% body weight loss
Plazo: 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
Urgent repair
Plazo: 1 year
Number of patients who require urgent hernia repair in either arm
Bariatric surgery prior to hernia repair and wounds
Plazo: 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
Bariatric surgery prior to hernia repair and hernia recurrence
Plazo: 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
Bariatric surgery prior to hernia repair and abdominal wall specific quality of life
Plazo: 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
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
2 centros
Northwestern UniversityChicago, Illinois, United StatesReclutando
Cleveland Clinic Main CampusCleveland, Ohio, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Benjamin T. Miller
- Inicio del estudio
- 19 jun 2023 Real
- Finalización primaria
- 1 jun 2028 Estimado
- Finalización del estudio
- 1 jun 2028 Estimado
- Primera publicación
- 29 jun 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Preoperative Weight Loss for Open Abdominal Wall Reconstruction
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026