Comparison of the Therapeutic Effects of VR and Hysteroscope + Laparoscope in the Treatment of Cesarean Scar Diverticula

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Therapeutic Effects of Vaginal Repair and Hysteroscopic Combined With Laparoscopic Excision in the Treatment of Cesarean Scar Diverticula

Conditions
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Cesarean Scar Diverticula

Participation Criteria
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Eligibility Criteria
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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). No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts. No gynaecology or other malignant tumors. Sign the informed consent. Exclusion Criteria: Over the age of 40; Indefinite diagnosis. The absence of clinical manifestations of CSD. 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. Use of intrauterine devices. Unwilling to comply with the research plan.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VR<br>The CSD patients are received treatment of vaginal repair. | |
| hysteroscope + laparoscope<br>The CSD patients are received treatment of hysteroscopic combined with laparoscopic excision. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of the remaining muscular layer (mm) | The thickness of the remaining muscular layer is measured by transvaginal ultrasound. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of menstruation (day) | The menstruation duration in CSD patients is collected 6 months after surgery. | 6 months after surgery | 
| the length of CSD (mm) | The length of CSD is measured by transvaginal ultrasound. | 6 months after surgery | 
| the depth of CSD (mm) | The depth of CSD is measured by transvaginal ultrasound. | 6 months after surgery | 
| the width of CSD (mm) | The width of CSD is measured by transvaginal ultrasound. | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Scar Diverticula