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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Xiuxiu Jiang, Ph.D & M.D
- Номер телефона: 2051 +86-0571-87061501
- Электронная почта: jiangxiuxiu0418@zju.edu.cn
Учебное резервное копирование контактов
- Имя: Zhejiang Provincial Clinical Research Center for Gynecological Women's Hospital, Zhejiang University School of Medicine
Места учебы
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Zhejiang
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Hangzhou, Zhejiang, Китай, 310006
- Women's Hospital, School of Medicine, Zhejiang University
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Контакт:
- Xiuxiu Jiang, Ph.D & M.D
- Номер телефона: 2051 +86-0571-87061501
- Электронная почта: jiangxiuxiu0418@zju.edu.cn
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Главный следователь:
- Ning Wang, M.D
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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 .
Другие имена:
|
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Активный компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from baseline in cesarean scar niche volume (mL)
Временное ограничение: Baseline, 3 months
|
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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change from baseline in abnormal vaginal bleeding
Временное ограничение: Baseline, 3, 6, 12 months
|
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
|
|
Reproductive outcome-clinical pregnancy rate
Временное ограничение: Baseline to 12 months
|
Include clinical pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome- ongoing pregnancy rate
Временное ограничение: Baseline to 12 months
|
Include ongoing pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - early pregnancy loss rate
Временное ограничение: Baseline to 12 months
|
Include early pregnancy loss rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - cesarean scar pregnancy rate
Временное ограничение: Baseline to 12 months
|
Include cesarean scar pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
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Incidence of adverse events
Временное ограничение: 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
Временное ограничение: 12 months
|
Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution. |
12 months
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- WHZ-JXX
- 2025C02122 (Другой номер гранта/финансирования: the Zhejiang Province's 2025 'Pioneer Leading Swan + X' Science and Technology Program)
- 2024ZY01028 (Другой номер гранта/финансирования: the Zhejiang Provincial Central Leading Local Science and Technology Development Fund Project)
- ZDFY2023-4XPY101 (Другой номер гранта/финансирования: the 4+X Clinical Research of Women's Hospital, School of Medicine, Zhejiang University)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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продукт, произведенный в США и экспортированный из США.
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