A Prospective, Multicenter, Controlled Clinical Study of Collagen Fibrous Scaffold for the Treatment of Cesarean Scar Diverticulum (CSD-SCAFFOLD)
Cesarean scar diverticulum (CSD, uterine niche) is a common long-term complication of cesarean delivery, frequently presenting with abnormal vaginal bleeding (postmenstrual spotting, prolonged menses), pelvic pain, and adverse reproductive outcomes. Current surgical repair yields variable niche shrinkage and inconsistent symptom and fertility improvement. This prospective, multicenter, controlled study aims to evaluate the efficacy and safety of collagen fibrous scaffold implantation versus conventional repair alone. Eligible symptomatic women will be enrolled from multiple tertiary obstetrics and gynecology centers. The primary outcome is change in CSD niche volume measured by transvaginal three-dimensional ultrasound. Secondary outcomes include improvement of abnormal vaginal bleeding and reproductive outcomes. Participants will be followed at 1, 3, 6, and 12 months postoperatively.
Descripción general del estudio
Estado
Descripción detallada
This is a prospective, multicenter, parallel controlled interventional study in symptomatic women with cesarean scar diverticulum. Subjects meeting the inclusion criteria will be allocated to the intervention group (collagen fibrous scaffold implantation) or the control group (standard surgical repair without scaffold).
Baseline assessments include transvaginal 3D ultrasound for niche volume measurement, menstrual symptom diary, pelvic pain evaluation, reproductive history, pelvic imaging, and routine laboratory tests. The index repair surgery (hysteroscopic combined laparoscopic) is performed per standardized protocol by experienced gynecologic surgeons. In the intervention group, the collagen fibrous scaffold is placed at the CSD to support tissue regeneration and scar remodeling. The control group receives identical surgical repair without scaffold implantation.
Follow-up visits are scheduled at 1, 3, 6, and 12 months after surgery. At each visit, adverse events, vaginal bleeding pattern, menstrual duration, and pelvic discomfort are recorded. Transvaginal 3D ultrasound is performed to quantify niche volume. Reproductive data including spontaneous conception, clinical pregnancy, pregnancy continuation, and pregnancy complications are collected up to 12 months. Safety endpoints include intraoperative hemorrhage, visceral injury, surgical site infection, scaffold-related reactions, pelvic adhesion, and persistent pain. All adverse events are graded for severity and assessed for relatedness to the study device or procedure.
Primary analysis compares between-group difference in niche volume change from baseline to 6 months. Secondary analyses compare abnormal vaginal bleeding parameters and reproductive outcomes. Safety profiles will be summarized. Analyses will be conducted on intention-to-treat and per-protocol populations.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xiuxiu Jiang, Ph.D & M.D
- Número de teléfono: 2051 +86-0571-87061501
- Correo electrónico: jiangxiuxiu0418@zju.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Zhejiang Provincial Clinical Research Center for Gynecological Women's Hospital, Zhejiang University School of Medicine
Ubicaciones de estudio
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310006
- Women's Hospital, School of Medicine, Zhejiang University
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Contacto:
- Xiuxiu Jiang, Ph.D & M.D
- Número de teléfono: 2051 +86-0571-87061501
- Correo electrónico: jiangxiuxiu0418@zju.edu.cn
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Investigador principal:
- Ning Wang, M.D
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At least one prior cesarean delivery
- CSD confirmed by transvaginal 3D ultrasound with measurable niche volume
- Symptomatic CSD: abnormal vaginal bleeding (prolonged menstruation, postmenstrual spotting, intermenstrual bleeding) attributed to the niche
- Candidate for surgical CSD repair and willing to complete scheduled follow-up
- Signed written informed consent
Exclusion Criteria:
- Current pregnancy or unwillingness to use effective contraception for the first 6 months postoperatively
- Coexisting uterine lesions requiring separate surgical intervention (submucous fibroids, large endometrial polyps, adenomyosis with dominant lesion)
- Active pelvic inflammatory disease or untreated genital tract infection
- Known allergy or hypersensitivity to collagen-derived biomaterials
- Severe systemic disease or coagulopathy that contraindicates pelvic surgery
- Suspected or confirmed gynecologic malignancy
- Inability or unwillingness to complete required follow-up assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm 1: Intervention Group
Collagen fibrous scaffold is implanted at the site of the cesarean scar diverticulum under 3D ultrasound guidance, without hysteroscopic or laparoscopic surgery. |
The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without implantable collagen fibrous scaffold .
Otros nombres:
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Comparador activo: Arm 2: Control Group
Identical hysteroscopic combined laparoscopic surgical repair of the CSD defect; no collagen fibrous scaffold is implanted. |
The diverticulum is localized under hysteroscopic guidance, and diverticulectomy and scar repair are performed laparoscopically without placement of implantable collagen fibrous scaffold. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in cesarean scar niche volume (mL)
Periodo de tiempo: Baseline, 3 months
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Cesarean scar niche volume will be assessed by three-dimensional transvaginal ultrasound and calculated by the ellipsoid formula （V = 0.523 × length × width × depth）at baseline and 3 months after intervention. |
Baseline, 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in abnormal vaginal bleeding
Periodo de tiempo: Baseline, 3, 6, 12 months
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Assessed by menstrual diary, including total menstrual bleeding days, days of postmenstrual spotting, and intermenstrual bleeding episodes per menstrual cycle. |
Baseline, 3, 6, 12 months
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Reproductive outcome-clinical pregnancy rate
Periodo de tiempo: Baseline to 12 months
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Include clinical pregnancy rate among participants attempting conception. |
Baseline to 12 months
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Reproductive outcome- ongoing pregnancy rate
Periodo de tiempo: Baseline to 12 months
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Include ongoing pregnancy rate among participants attempting conception. |
Baseline to 12 months
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Reproductive outcome - early pregnancy loss rate
Periodo de tiempo: Baseline to 12 months
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Include early pregnancy loss rate among participants attempting conception. |
Baseline to 12 months
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Reproductive outcome - cesarean scar pregnancy rate
Periodo de tiempo: Baseline to 12 months
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Include cesarean scar pregnancy rate among participants attempting conception. |
Baseline to 12 months
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Incidence of adverse events
Periodo de tiempo: Intraoperative through 12 months
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All device-related and procedure-related adverse events, graded by severity and causality. |
Intraoperative through 12 months
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Recurrence rate of cesarean scar diverticulum
Periodo de tiempo: 12 months
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Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution. |
12 months
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Tosi A, Haas C, Herzog F, Gilmozzi A, Berninghausen O, Ungewickell C, Gerhold CB, Lakomek K, Aebersold R, Beckmann R, Hopfner KP. Structure and subunit topology of the INO80 chromatin remodeler and its nucleosome complex. Cell. 2013 Sep 12;154(6):1207-19. doi: 10.1016/j.cell.2013.08.016.
- Perkins JR, Parker CE, Tomer KB. Nanoscale separations combined with electrospray ionization mass spectrometry: Sulfonamide determination. J Am Soc Mass Spectrom. 1992 Feb;3(2):139-49. doi: 10.1016/1044-0305(92)87047-3.
Enlaces Útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WHZ-JXX
- 2025C02122 (Otro número de subvención/financiamiento: the Zhejiang Province's 2025 'Pioneer Leading Swan + X' Science and Technology Program)
- 2024ZY01028 (Otro número de subvención/financiamiento: the Zhejiang Provincial Central Leading Local Science and Technology Development Fund Project)
- ZDFY2023-4XPY101 (Otro número de subvención/financiamiento: the 4+X Clinical Research of Women's Hospital, School of Medicine, Zhejiang University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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