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

February 26, 2014 updated by: Shu-Qin Chen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fan Li, M.D
  • Phone Number: 8342 +862087332200
  • Email: 37488373@qq.com

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fan Li, M.D
        • Sub-Investigator:
          • Li Jing-Bo, M.D
        • Sub-Investigator:
          • Kong Ling-Zhi, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

60 patients diagnosed PCSD scheduled for vaginal operation in The First Affiliated Hospital between December 2013 and December 2015

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transvaginal resection of Uterine Scar
transvaginal resection of Uterine Scar From Previous Cesarean Delivery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The safety of transvaginal resection of caesarean scar deficiency in the treatment of PCSD
Time Frame: one week
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the effectiveness of transvaginal resection of caesarean scar deficiency in the treatment of PCSD.
Time Frame: one year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
the result of transvaginal resection of caesarean scar deficiency in affecting quality of (sex)life.
Time Frame: one year
two questionnaires results:FSFI and HRQoL
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shu-Qin Chen

Investigators

  • Study Chair: Yao Shu-Zhong, M.D&Ph.D, First Affiliated Hospital, Sun Yat-Sen University
  • Study Director: Chen Shu-Qin, M.D&PhD, First Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Fan Li, M.D, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHEN-PCSD
  • PCSD-2013 (Other Identifier: Hospital Ethical Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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