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

NCT ID: NCT02933216

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-06-30

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.

Conditions

Cesarean Scar Diverticula

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

VR

The CSD patients are received treatment of vaginal repair.

No interventions assigned to this group

hysteroscope + laparoscope

The CSD patients are received treatment of hysteroscopic combined with laparoscopic excision.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xipeng Wang, M.D., Ph.D.,

Role: STUDY_CHAIR

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Locations

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Xipeng Wang, M.D., Ph.D.,

Role: CONTACT

xipengwang@hotmail.com

86-13817806602

Xiaoqian Yang, M.D., Ph.D.,

Role: CONTACT

yangxiaoqian1986@126.com

86-18516703569

Other Identifiers

CSD-002

Identifier Type: -

Identifier Source: org_study_id