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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01978067
Other study ID # CHEN-PCSD
Secondary ID PCSD-2013
Status Recruiting
Phase N/A
First received October 31, 2013
Last updated February 26, 2014
Start date January 2013
Est. completion date December 2015

Study information

Verified date February 2014
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Chen Shu-Qin, PhD & MD
Phone +862087332200
Email chenshuqin1021@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to further demonstrate the safety , validity and quality of (sexual)life of vaginal operation for previous cesarean scar defect resection.


Description:

collect all the patients'clinical information,use two questionnaire (the HRQoL and FSFI)to estimate patients' general healthy and sexual function before surgery and postoperation in 1 month,3 months and 6 months


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- preoperative diagnosed as PCSD

- hemodynamic stability

Exclusion Criteria:

- irregular menstrual cycle

- using IUD

- complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
transvaginal resection of Uterine Scar
Expose, grasp and traction the cervix. An incision was made at the anterior cervicovaginal junction, and the bladder was dissected away until the anterior peritoneal reflection was identified. The anterior drawing hook was inserted.into the vaginal incision to retract the bladder upwards. The PCSD was identified as a'fornix' located in the anterior part of the lower uterine segment. A transverse incision was made to remove the scar deficiency, and the edges of the incision were trimmed with scissors, and the myometrial and vaginal defects were closed.

Locations

Country Name City State
China The First Affiliated Hospital of Sun Yat-sen University GuangZhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shu-Qin Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other the result of transvaginal resection of caesarean scar deficiency in affecting quality of (sex)life. two questionnaires results:FSFI and HRQoL one year No
Primary The safety of transvaginal resection of caesarean scar deficiency in the treatment of PCSD blood loss, hemoglobin in the first postoperative day, operation time, preoperative and postoperative complications,change to other treatment,vaginal bleeding after surgery and length of stay are collected to evaluate the safety of this procedure. one week Yes
Secondary the effectiveness of transvaginal resection of caesarean scar deficiency in the treatment of PCSD. Observation of menstruation in three months,six months and nine months after surgery is applied for evaluating the effectiveness of this procedure and transvaginal ultrasound,hysteroscopy and Gynecological Examination are performed after surgery.Situation of fertility ,(sex)quality of life after surgery also are very important indicator of this procedure effectiveness one year No
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