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

NCT02933216 | Unknown

• 1 other identifier: CSD-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Cesarean Scar Diverticula

Outcome Measures

Primary Outcomes (1)

• thickness of the remaining muscular layer (mm)

  The thickness of the remaining muscular layer is measured by transvaginal ultrasound.

  6 months after surgery

Secondary Outcomes (4)

• duration of menstruation (day)

  6 months after surgery

• the length of CSD (mm)

  6 months after surgery

• the depth of CSD (mm)

  6 months after surgery

• the width of CSD (mm)

  6 months after surgery

Study Arms (2)

VR

The CSD patients are received treatment of vaginal repair.

hysteroscope + laparoscope

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cesarean section diverticula patients from Nov 2016 until June 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201204, China

Location

Study Officials

• Xipeng Wang, M.D., Ph.D.,

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

  STUDY CHAIR

Central Study Contacts

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

CONTACT

86-13817806602; xipengwang@hotmail.com

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

CONTACT

86-18516703569; yangxiaoqian1986@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 14, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

CN (1)