Cesarean Scar DiverticulaNCT02933216
Comparison of the Therapeutic Effects of VR and Hysteroscope + Laparoscope in the Treatment of Cesarean Scar Diverticula
An observational study of Cesarean Scar Diverticula, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Scar Diverticula
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Jun 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Cesarean section diverticula patients from Nov 2016 until June 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.
Who may be able to join
- Patients are younger than 40.
- Clearly diagnosed with CSD.
- Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
- The thickness of the remaining muscular layer of CSD was less than 3 mm.
- The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
- The medicine conservative treatment is invalid.
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- Refusing or use birth control pills contraindications.
- No serious medical problems (important viscera function in the normal range).
- No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts.
- No gynaecology or other malignant tumors.
- Sign the informed consent.
Who cannot join
- Over the age of 40;
- Indefinite diagnosis.
- The absence of clinical manifestations of CSD.
- The presence of menstrual irregularities before cesarean delivery.
- Coagulation disorders.
- Malignant tumors.
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- With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).
- Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section.
- Use of intrauterine devices.
- Unwilling to comply with the research plan.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Shanghai, Shanghai Municipality, 201204
About this study
Official title: Comparison of the Therapeutic Effects of Vaginal Repair and Hysteroscopic Combined With Laparoscopic Excision in the Treatment of Cesarean Scar Diverticula
Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. Currently, several limited surgical management procedures for CSD have been reported, such as hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope) and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.
- Conditions
- Cesarean Scar Diverticula
- Keywords
- Cesarean Scar Diverticula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VR | The CSD patients are received treatment of vaginal repair. | |
| hysteroscope + laparoscope | The CSD patients are received treatment of hysteroscopic combined with laparoscopic excision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness of the remaining muscular layer (mm)
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
Measured: 6 months after surgery
Secondary outcomes (4)
duration of menstruation (day)
The menstruation duration in CSD patients is collected 6 months after surgery.
Measured: 6 months after surgery
the length of CSD (mm)
The length of CSD is measured by transvaginal ultrasound.
Measured: 6 months after surgery
the depth of CSD (mm)
The depth of CSD is measured by transvaginal ultrasound.
Measured: 6 months after surgery
the width of CSD (mm)
The width of CSD is measured by transvaginal ultrasound.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar DiverticulaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xipeng Wang, M.D., Ph.D.,, Study chair, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933216
- Sponsor's protocol ID
- CSD-002
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Therapeutic Effects of Vaginal Repair and Hysteroscopic Combined With Laparoscopic Excision in the Treatment of Cesarean Scar Diverticula
- ClinicalTrials.gov ID
- NCT02933216
- Acronym / sponsor ID
- CSD-002
- Conditions
- Cesarean Scar Diverticula
- Keywords
- Cesarean Scar Diverticula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 Oct 2016 (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.
Cesarean scar diverticula (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. Currently, several limited surgical management procedures for CSD have been reported, such as hysteroscopic combined with laparoscopic excision (abbreviated as hysteroscope + laparoscope) and vaginal repair of CSD (abbreviated as VR). However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the therapeutic effects between VR and hysteroscope + laparoscope in the treatment of CSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR | – | –The CSD patients are received treatment of vaginal repair. |
| hysteroscope + laparoscope | – | –The CSD patients are received treatment of hysteroscopic combined with laparoscopic excision. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cesarean section diverticula patients from Nov 2016 until June 2018 in Shanghai First Maternity and Infant Hospital, Tongji University.
Key inclusion criteria (11 listed)
- Patients are younger than 40.
- Clearly diagnosed with CSD.
- Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days).
- The thickness of the remaining muscular layer of CSD was less than 3 mm.
- The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation.
Key exclusion criteria (10 listed)
- Over the age of 40;
- Indefinite diagnosis.
- The absence of clinical manifestations of CSD.
- The presence of menstrual irregularities before cesarean delivery.
- Coagulation disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
thickness of the remaining muscular layer (mm)
Time frame: 6 months after surgery
The thickness of the remaining muscular layer is measured by transvaginal ultrasound.
4 secondary outcomes
duration of menstruation (day)
Time frame: 6 months after surgery
the length of CSD (mm)
Time frame: 6 months after surgery
the depth of CSD (mm)
Time frame: 6 months after surgery
the width of CSD (mm)
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
Xipeng Wang, M.D., Ph.D., study chair
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji 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 Cesarean Scar Diverticula, run by Shanghai First Maternity and Infant Hospital 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 11 inclusion and 10 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 14 Oct 2016. 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 Xipeng Wang, M.D., Ph.D., (86-13817806602, xipengwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of the remaining muscular layer (mm) (time frame: 6 months after surgery). 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 14 Oct 2016.