- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608653
Outcomes of Laparoscopic Keyhole Surgery (TAPP) for Recurrent Inguinal Hernia
Clinical Outcomes of Laparoscopic Transabdominal Preperitoneal (TAPP) Approach for Recurrent Inguinal Hernia
The goal of this clinical trial is to learn if a laparoscopic surgery called Transabdominal Preperitoneal (TAPP) repair is safe and works well for adults with a recurrent inguinal hernia (a groin hernia that has returned after a previous operation).
The main questions it aims to answer are:
Does the TAPP technique lower the number of complications after surgery? How well do participants recover during the early postoperative period and long-term follow-up? Fixing a hernia that has returned is hard because of old scar tissue. In this study, researchers will use the TAPP technique to work through a different layer of tissue to provide a stronger repair.
Participants will:
Undergo the TAPP laparoscopic surgery for their recurrent hernia. Visit the clinic for close health monitoring shortly after surgery. Complete regular follow-up checkups to track their long-term recovery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: marwa Saber, Resident
- Número de teléfono: 01017659722
- Correo electrónico: marwaelkholy93@gmail.com
Ubicaciones de estudio
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Sohag, Egipto
- Reclutamiento
- Faculty of Medicine
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Contacto:
- marwa elkholy, Resident
- Número de teléfono: 01017659722
- Correo electrónico: marwaelkholy93@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients. Patients diagnosed with recurrent inguinal hernia. Patients fit for general anesthesia. Patients who provide informed consent.
Exclusion Criteria:
- Non recurrent inguinal hernia Patients with complicated inguinal hernia. Patients unfit for general anesthesia. Patients refusing participation in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Laparoscopic TAPP Repair
Patients with recurrent inguinal hernia who will undergo laparoscopic transabdominal preperitoneal (TAPP) repair using a synthetic mesh.
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The surgical procedure will be performed under general anesthesia.
Standard laparoscopic instruments will be used to access the peritoneal cavity.
The peritoneum over the recurrent inguinal hernia site will be incised to enter the preperitoneal space.
After reduction of the hernia sac and clearing of post-operative adhesions, a synthetic mesh will be placed to cover the hernia defects.
The mesh will be secured if necessary, and the peritoneal flap will be closed using sutures or tacks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility and Technical Success of Laparoscopic TAPP
Periodo de tiempo: During the intraoperative procedure (Day of surgery)
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Evaluation of the feasibility of the TAPP approach in recurrent inguinal hernias, measured by the rate of successful laparoscopic completion without the need for intraoperative conversion to open surgery due to severe scar tissue or adhesions.
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During the intraoperative procedure (Day of surgery)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Post-operative Pain
Periodo de tiempo: At 24 hours, 1 week, and 1 month post-operatively
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Assessment of pain severity using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain).
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At 24 hours, 1 week, and 1 month post-operatively
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Hernia Recurrence
Periodo de tiempo: 4 months
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The percentage of patients who experience another clinical return of the inguinal hernia after the TAPP repair.
Recurrence will be detected through physical examination during follow-up, and confirmed by groin ultrasound or CT scan if a hernia is clinically suspected.
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4 months
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Operative Time
Periodo de tiempo: During the surgical procedure (Day of surgery)
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The total duration of the surgical procedure calculated in minutes from the skin incision to the final closure
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During the surgical procedure (Day of surgery)
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Length of Hospital Stay
Periodo de tiempo: From the day of surgery up to hospital discharge (typically 1-2 days)
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The total number of hours or days from the end of the surgery until the patient is officially discharged from the hospital.
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From the day of surgery up to hospital discharge (typically 1-2 days)
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Incidence of Post-operative Complications
Periodo de tiempo: Up to 4 months post-operatively
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Detection of any early complications like seroma, hematoma, or wound infection.
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Up to 4 months post-operatively
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Incidence of Intraoperative Complications
Periodo de tiempo: During the surgical procedure (Day of surgery)
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The percentage of patients experiencing any surgical complications during the operation, such as urinary bladder injury, bowel injury, or major vascular bleeding
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During the surgical procedure (Day of surgery)
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Time to Return to Normal Daily Activities
Periodo de tiempo: Up to 4 months post-operatively
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The total number of days taken by the patient to independently resume their baseline activities of daily living and return to light work/routine post-surgery.
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Up to 4 months post-operatively
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Soh-Med-26-5-3MS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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