Comparison of the Therapeutic Effects of VR and Hysteroscope + Laparoscope in the Treatment of Ce… (NCT02933216) | Clinical Trial Compass
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Comparison of the Therapeutic Effects of VR and Hysteroscope + Laparoscope in the Treatment of Cesarean Scar Diverticula
China100 participantsStarted 2016-11
Plain-language summary
Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. Currently, several limited surgical management procedures for CSD have been reported, such as hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope) and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients are younger than 40.
✓. Clearly diagnosed with CSD.
✓. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
✓. The thickness of the remaining muscular layer of CSD was less than 3 mm.
✓. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
✓. The medicine conservative treatment is invalid.
✓. Refusing or use birth control pills contraindications.
✓. No serious medical problems (important viscera function in the normal range).
Exclusion criteria
✕. Over the age of 40;
✕. Indefinite diagnosis.
What they're measuring
1
thickness of the remaining muscular layer (mm)
Timeframe: 6 months after surgery
Trial details
NCT IDNCT02933216
SponsorShanghai First Maternity and Infant Hospital
✕. The presence of menstrual irregularities before cesarean delivery.
✕. Coagulation disorders.
✕. Malignant tumors.
✕. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
✕. Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.