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

NCT01978067 | Unknown DMC

• 2 other identifiers: CHEN-PCSDPCSD-2013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; Sexual Activity

Keywords

Uterine Scar From Previous Cesarean Delivery; previous caesarean scar deficiency; transvaginal resection; quality of life; sexual activity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the effectiveness of transvaginal resection of caesarean scar deficiency in the treatment of PCSD.

  one year

Other Outcomes (1)

• the result of transvaginal resection of caesarean scar deficiency in affecting quality of (sex)life.

  one year

Study Arms (1)

transvaginal resection of Uterine Scar

transvaginal resection of Uterine Scar From Previous Cesarean Delivery

Procedure: transvaginal resection of Uterine Scar

Interventions

transvaginal resection of Uterine Scar PROCEDURE

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.

transvaginal resection of Uterine Scar

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• preoperative diagnosed as PCSD
• hemodynamic stability

You may not qualify if:

• irregular menstrual cycle
• using IUD
• complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.

Sponsors & Collaborators

• Shu-Qin Chen: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chen Shu-Qin, M.D&PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

• Yao Shu-Zhong, M.D&Ph.D

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

• Fan Li, M.D

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Shu-Qin, PhD & MD

CONTACT

+862087332200; chenshuqin1021@163.com

Fan Li, M.D

CONTACT

+862087332200; 37488373@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor of gynaecology and obstetricsf

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

CN (1)