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

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Scar Diverticula

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201204
      • Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VR; The CSD patients are received treatment of vaginal repair.
hysteroscope + laparoscope; The CSD patients are received treatment of hysteroscopic combined with laparoscopic excision.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital
• Investigators: Study Chair: Xipeng Wang, M.D., Ph.D.,, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Cesarean Scar Diverticula
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: CSD-002