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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Xiuxiu Jiang, Ph.D & M.D
- Telefonnummer: 2051 +86-0571-87061501
- E-mail: jiangxiuxiu0418@zju.edu.cn
Undersøgelse Kontakt Backup
- Navn: Zhejiang Provincial Clinical Research Center for Gynecological Women's Hospital, Zhejiang University School of Medicine
Studiesteder
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310006
- Women's Hospital, School of Medicine, Zhejiang University
-
Kontakt:
- Xiuxiu Jiang, Ph.D & M.D
- Telefonnummer: 2051 +86-0571-87061501
- E-mail: jiangxiuxiu0418@zju.edu.cn
-
Ledende efterforsker:
- Ning Wang, M.D
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 .
Andre navne:
|
|
Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in cesarean scar niche volume (mL)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in abnormal vaginal bleeding
Tidsramme: 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
Tidsramme: Baseline to 12 months
|
Include clinical pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome- ongoing pregnancy rate
Tidsramme: Baseline to 12 months
|
Include ongoing pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - early pregnancy loss rate
Tidsramme: Baseline to 12 months
|
Include early pregnancy loss rate among participants attempting conception. |
Baseline to 12 months
|
|
Reproductive outcome - cesarean scar pregnancy rate
Tidsramme: Baseline to 12 months
|
Include cesarean scar pregnancy rate among participants attempting conception. |
Baseline to 12 months
|
|
Incidence of adverse events
Tidsramme: Intraoperative through 12 months
|
All device-related and procedure-related adverse events, graded by severity and causality. |
Intraoperative through 12 months
|
|
Recurrence rate of cesarean scar diverticulum
Tidsramme: 12 months
|
Recurrence defined as reappearance of measurable niche on 3D ultrasound after initial shrinkage or resolution. |
12 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- WHZ-JXX
- 2025C02122 (Andet bevillings-/finansieringsnummer: the Zhejiang Province's 2025 'Pioneer Leading Swan + X' Science and Technology Program)
- 2024ZY01028 (Andet bevillings-/finansieringsnummer: the Zhejiang Provincial Central Leading Local Science and Technology Development Fund Project)
- ZDFY2023-4XPY101 (Andet bevillings-/finansieringsnummer: the 4+X Clinical Research of Women's Hospital, School of Medicine, Zhejiang University)
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