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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Comparison of the Therapeutic Effects of Vaginal Repair and Hysteroscopic Combined With Laparoscopic Excision in the Treatment of 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.

Detailed Summary:
Sponsor: Shanghai First Maternity and Infant Hospital

Current Primary Outcome: thickness of the remaining muscular layer (mm) [ Time Frame: 6 months after surgery ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Shanghai First Maternity and Infant Hospital

Dates:
Date Received: October 11, 2016
Date Started: November 2016
Date Completion: June 2018
Last Updated: October 12, 2016
Last Verified: October 2016