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

Cesarean Scar Diverticula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02933216
• Other study ID #: CSD-002
• Status: Not yet recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 12, 2016
• Start date: November 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Xipeng Wang, M.D., Ph.D.,
• Phone: 86-13817806602
• Email: xipengwang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cesarean Scar Diverticula
• Diverticulum

Locations

Country	Name	City	State
China	Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thickness of the remaining muscular layer (mm)	The thickness of the remaining muscular layer is measured by transvaginal ultrasound.	6 months after surgery	No
Secondary	duration of menstruation (day)	The menstruation duration in CSD patients is collected 6 months after surgery.	6 months after surgery	No
Secondary	the length of CSD (mm)	The length of CSD is measured by transvaginal ultrasound.	6 months after surgery	No
Secondary	the depth of CSD (mm)	The depth of CSD is measured by transvaginal ultrasound.	6 months after surgery	No
Secondary	the width of CSD (mm)	The width of CSD is measured by transvaginal ultrasound.	6 months after surgery	No