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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02933216

Enrollment

100

Registered

2016-10-14

Start date

2016-11-30

Completion date

2018-06-30

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Scar Diverticula

Keywords

Cesarean Scar Diverticula

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactXipeng Wang, M.D., Ph.D.,

xipengwang@hotmail.com86-13817806602

Backup ContactXiaoqian Yang, M.D., Ph.D.,

yangxiaoqian1986@126.com86-18516703569

Outcome results