Quality of LifePCSDNCT01978067
Quality of Life and Sexual Function of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect
An observational study of Quality of Life and Sexual Activity, run by Shu-Qin Chen at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Quality of Life, Sexual Activity
- What is being tested?
- transvaginal resection of Uterine Scar
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 60 patients diagnosed PCSD scheduled for vaginal operation in The First Affiliated Hospital between December 2013 and December 2015
Who may be able to join
- preoperative diagnosed as PCSD
- hemodynamic stability
Who cannot join
- irregular menstrual cycle
- using IUD
- complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Chen Shu-Qin, M.D&Ph.D, +862087332200 ext. 8342, chenshuqin1021@163.com
Fan Li, M.D, +862087332200 ext. 8342, 37488373@qq.com
About this study
Official title: 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.
Read the 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
- Conditions
- Quality of Life, Sexual Activity
- Being tested
- transvaginal resection of Uterine Scar
- Keywords
- Uterine Scar From Previous Cesarean Delivery, previous caesarean scar deficiency, transvaginal resection, quality of life, sexual activity
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal resection of Uterine ScarProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| transvaginal resection of Uterine Scar | transvaginal resection of Uterine Scar From Previous Cesarean Delivery Receives: Procedure: transvaginal resection of Uterine Scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Secondary outcomes (1)
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shu-Qin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shu-Qin Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Chen Shu-Qin, M.D&PhD, Study director, First Affiliated Hospital, Sun Yat-Sen UniversityYao Shu-Zhong, M.D&Ph.D, Study chair, First Affiliated Hospital, Sun Yat-Sen UniversityFan Li, M.D, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978067
- Sponsor's protocol ID
- CHEN-PCSD
- Other IDs
- PCSD-2013
- Acronym
- PCSD
- Status last verified
- Feb 2014
- First submitted
- 31 Oct 2013
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety ,Validity and Quality of (Sexual)Life of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect
- ClinicalTrials.gov ID
- NCT01978067
- Acronym / sponsor ID
- PCSD / CHEN-PCSD
- Conditions
- Quality of Life, Sexual Activity
- Keywords
- Uterine Scar From Previous Cesarean Delivery, previous caesarean scar deficiency, transvaginal resection, quality of life, sexual activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shu-Qin ChenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transvaginal resection of Uterine Scar | – | Procedure: transvaginal resection of Uterine Scartransvaginal resection of Uterine Scar From Previous Cesarean Delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 patients diagnosed PCSD scheduled for vaginal operation in The First Affiliated Hospital between December 2013 and December 2015
Key inclusion criteria (2 listed)
- preoperative diagnosed as PCSD
- hemodynamic stability
Key exclusion criteria (3 listed)
- irregular menstrual cycle
- using IUD
- complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal resection of Uterine ScarExpose, 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. | Procedure or surgery | transvaginal resection of Uterine Scar |
Primary outcome
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.
1 secondary outcome
the effectiveness of transvaginal resection of caesarean scar deficiency in the treatment of PCSD.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Shu-Qin, M.D&PhD study director
First Affiliated Hospital, Sun Yat-Sen University
Yao Shu-Zhong, M.D&Ph.D study chair
First Affiliated Hospital, Sun Yat-Sen University
Fan Li, M.D principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Sexual Activity, run by Shu-Qin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Shu-Qin, PhD & MD (+862087332200 ext. 8342, chenshuqin1021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of transvaginal resection of caesarean scar deficiency in the treatment of PCSD (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.