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

• Conditions: Cesarean Scar Diverticula

• Registration Number: NCT02933216
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-14
• Last Update Posted: 2016-10-14
• Study Start: 2016-11
• Primary Completion: 2018-01
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Patients are younger than 40.
2. Clearly diagnosed with CSD.
3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
4. The thickness of the remaining muscular layer of CSD was less than 3 mm.
5. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
6. The medicine conservative treatment is invalid.
7. Refusing or use birth control pills contraindications.
8. No serious medical problems (important viscera function in the normal range).
9. No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.
10. No gynaecology or other malignant tumors.
11. Sign the informed consent.

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Exclusion Criteria

1. Over the age of 40;
2. Indefinite diagnosis.
3. The absence of clinical manifestations of CSD.
4. The presence of menstrual irregularities before cesarean delivery.
5. Coagulation disorders.
6. Malignant tumors.
7. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
8. Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.
9. Use of intrauterine devices.
10. Unwilling to comply with the research plan.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thickness of the remaining muscular layer (mm)	6 months after surgery	The thickness of the remaining muscular layer is measured by transvaginal ultrasound.

Secondary Outcome Measures

Name	Time	Method
duration of menstruation (day)	6 months after surgery	The menstruation duration in CSD patients is collected 6 months after surgery.
the width of CSD (mm)	6 months after surgery	The width of CSD is measured by transvaginal ultrasound.
the depth of CSD (mm)	6 months after surgery	The depth of CSD is measured by transvaginal ultrasound.
the length of CSD (mm)	6 months after surgery	The length of CSD is measured by transvaginal ultrasound.

Trial Locations

Locations (1)

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University; 🇨🇳 Shanghai, Shanghai, China