Quality of Life and Sexual Function of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect

Quality of Life Clinical Trial

— PCSD  

Official title:

Safety ,Validity and Quality of (Sexual)Life of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect

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

• Quality of Life
• Sexual Activity

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