Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
Laparoscopic repair of Isthmocele aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Isthmocele, also known as a cesarean scar defect (CSD), is a common complication following cesarean section, characterized by a myometrial defect at the site of the hysterotomy scar. It can lead to various symptoms including abnormal uterine bleeding, dysmenorrhea, pelvic pain, and infertility.
Laparoscopic repair aims to restore the anatomical integrity and physiological function of the lower uterine segment.
- Vertical Closure: This technique involves closing the defect along the longitudinal axis of the uterus. Proponents suggest it may be more anatomically aligned with the muscle fibers of the lower uterine segment, potentially leading to stronger scar formation and reduced tension.
- Transverse Closure: This technique involves closing the defect perpendicular to the long axis of the uterus. This approach is more commonly used during primary cesarean sections.
Arguments for transverse closure in isthmocele repair include familiarity for surgeons and potentially less shortening of the lower uterine segment.
However, the actual impact of these different closure methods on long-term outcomes such as defect recurrence, scar integrity, and fertility, remains largely unexplored in a randomized controlled trial setting.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Women aged 18-45 years.
- Diagnosis of symptomatic isthmocele confirmed by transvaginal ultrasound (myometrial thickness at the defect < 2.5 mm).
- History of at least one prior cesarean section.
- Symptoms attributable to isthmocele (e.g., abnormal uterine bleeding, pelvic pain, dysmenorrhea, secondary infertility).
- Desire for surgical correction of isthmocele.
- Ability to understand and provide informed consent
Exclusion Criteria:
- Asymptomatic isthmocele.
- Active pelvic infection or malignancy.
- Significant medical comorbidities contraindicating laparoscopic surgery.
- Coagulopathy.
- Known uterine anomalies (e.g., bicornuate uterus).
- Pregnancy at the time of recruitment.
- Inability to comply with follow-up protocol.
Plan de estudios
¿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 |
|---|---|
|
Comparador activo: Vertical Closure Group
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
|
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures along the longitudinal axis of the uterus
|
|
Comparador activo: Transverse Closure Group
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus
|
The hysterotomy defect will be closed in two layers using interrupted or continuous sutures perpendicular to the longitudinal axis of the uterus
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative lower uterine segment scar thickness
Periodo de tiempo: 6 and 12 months post-surgery using transvaginal ultrasound
|
To evaluate the thickness of the lower uterine segment scar at 6 and 12 months post-surgery using transvaginal ultrasound
|
6 and 12 months post-surgery using transvaginal ultrasound
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 1704-9-2025
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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Ensayos clínicos sobre Vertical Closure
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Helse Stavanger HFHaydom Lutheran HospitalTerminado
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TC Erciyes UniversityTerminado
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University of Kansas Medical CenterInscripción por invitaciónEvaluación Prospectiva de Mielografía por TC en Posición Vertical versus Supina de la Columna LumbarEstenosis del Canal Central Lumbar | Estenosis foraminal neuralEstados Unidos
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Peter MorrisTerminado
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University of California, IrvineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...ReclutamientoObesidad | La enfermedad por reflujo gastroesofágico | Cirugía bariátrica | Banda gástricaEstados Unidos
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Indiana UniversityTerminado
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Clinica GastrobeseActivo, no reclutandoObesidad | Reflujo GastroesofágicoBrasil