Cesarean Scar DefectNCT06917014
Hysteroscopic "360°" Surgery for Improvement of Symptoms in Cesarean Scar Defects
A study testing 360° and traditional in people with Cesarean Scar Defect, run by Fu Xing Hospital, Capital Medical University.
Trial summary
Patients with symptomatic Cesarean Scar Defect (CSD) who are expected to undergo hysteroscopic surgery will be randomly divided into the traditional hysteroscopic "channelization" treatment group and the hysteroscopic "360 °" Surgery group of cesarean diverticulum, and the improvement of postoperative clinical… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Scar Defect
- What is being tested?
- 360° and traditional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2025to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with surgical adaptation: changes in menstruation after cesarean section (prolonged menstrual period)
- No surgical contraindications;
- Age 18-45 years old;
- The thickness of residual muscle layer measured by ultrasound is greater than or equal to 2.5mm;
- Patients with symptoms that have not improved significantly for more than 1 month after oral short-acting contraceptive cycle treatment or who strongly require surgery;
- Understand and agree to the research plan.
Who cannot join
- Patients with other diseases that may cause abnormal uterine bleeding (including endometrial polyps, endometrial hyperplasia, submucosal myoma, etc.) indicated by two-dimensional ultrasound
- There are contraindications of surgery: such as severe internal and surgical complications, pregnancy, reproductive tract infection, malignant tumor;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Study of Hysteroscopic "360°" Surgery for Improvement of Symptoms in Cesarean Scar Defects
Patients with symptomatic Cesarean Scar Defect (CSD) who are expected to undergo hysteroscopic surgery will be randomly divided into the traditional hysteroscopic "channelization" treatment group and the hysteroscopic "360 °" Surgery group of cesarean diverticulum, and the improvement of postoperative clinical symptoms of the two groups will be compared. To evaluate the effectiveness of the two surgical methods.
The purpose of this study was to evaluate the improvement of symptoms of women with symptomatic cesarean diverticulum through a high-quality randomized controlled study, in order to provide high-level evidence-based medical evidence for clinical treatment.
Read the detailed description
- Study Design：This is a prospective, randomized controlled trial.
- Study population 120 patients diagnosed with Cesarean Scar Defect (CSD) will be prospectively recruited. Before the surgery all patients will undergo preoperative evaluations, including a detailed history of the menstrual pattern,any previous History of cesarean section, and reproductive history, as well as trans-vaginal ultrasonography and Three-dimensional SIS Ultrasound.
- Randomization: Randomization was performed electronically using SPSS statistical software version 26.0 (SPSS, Inc., Chicago, IL,USA) by the investigator.120 recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: the control group("channelization" group) and the experimental group("360°" group).
- Surgical technique: Hysteroscopic surgery will be performed in a standardized manner.The procedure will be performed under general anesthesia. Ultrasonographic guidance will be routinely used. The interference of "360°" group (the experimental group) including 60 CSD patients ,With the vaginoscopic approach, the isthmocele was localized; a high-frequency 90°angled circular loop electrode and pure cutting current of 100 W were used to resect the fibrotic tissue of the proximal (step 1) and distal (step 2) part of the niche. The investigators performed resection not only of the fibrotic tissue underneath the niche but also of the inflamed tissue placed around the niche and on the opposite site (the so-called channel-like 360° endocervical ablation). A high-frequency angled ball electrode was used to obtain focused coagulation of all residual inflamed tissue still present on the niche surface and on the cervical canal walls (step 3); the aim of this step is to facilitate the re-epithelialization of the cervical canal walls by the paraphysiological endocervical epithelium. The procedure was ended by controlling any bleeding of the endocervical vessels by reducing the inflow and pressure of the distending medium and by focused electrocauterization with a ball electrode (step 4).while the interference of "channelization" group (the control group) , With the vaginoscopic approach, the isthmocele was localized; a high-frequency 90°angled circular loop electrode and pure cutting current of 100 W were used to resect the fibrotic tissue of the proximal perform intrauterine adhesiolysis with bipolar electric needle electrode, part of the scar tissue removed by electronic loop when it is necessary.A angled ball electrode was used to obtain focused coagulation of proliferating blood vessels, inflammatory tissue, and ectopic endometrium in the diverticulum.In both arms, the endometrium tissue was removed and sent to pathology, followed by immunohistochemical CD138 examination
- Postoperative treatments All subjects will be treated with oral antibiotics for 3 days. Three-dimensional SIS Ultrasound will be carried out 3 months after the surgery.
- Follow up: Follow-up styles: the doctor's outpatient review, patients fill in questionnaires,telephone, WeChat and so on. Follow-up time:3 months and 6 months after the operation. Follow-up contents: the data measured by 3D-SIS,At the same time, the endometrium was taken again for immunohistochemical CD138 examination. Assessed the improvement of symptoms, including the improvement of prolonged menstrual period, the improvement of heavy menstruation, and the patient's postoperative satisfaction.
- Consent： All subjects will be given a detailed explanation of the study and sufficient time to consider their participation. A written consent form will be signed by the patient and retained in the records.
- Conditions
- Cesarean Scar Defect
- Being tested
- 360°, traditional
- Keywords
- Hysteroscopic "360°" Surgery, Cesarean Scar Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360°Procedure or surgery
reset the proximal and distal part of the niche, widely 360° coagulation to restore and change the shape and size of niche, and ultimately improve symptoms of patients.
traditionalProcedure or surgery
reset the proximal part of the niche, and coagulation to restore and change the shape and size of niche, and ultimately improve symptoms of patients.
| Study group | Role | What they receive |
|---|---|---|
| 360° | Experimental | The interference of the experimental group is to resect the fibrotic inflamed tissue of the proximal and distal part of the niche, a high-frequency angled ball electrode was used to obtain focused coagulation of all residual inflamed tissue still present on the niche surface and on the cervical canal walls, focused electrocauterization with a ball electrode controlling any bleeding of the endocervical vessels. Receives: Procedure: 360° |
| traditional | Other | The interference of the control group is to resect the fibrotic tissue of the proximal of the niche, use angled ball electrode coagulation. Receives: Procedure: traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom change rate
Rate of change in abnormal bleeding before and after the operation
Measured: 6 months after surgery
Secondary outcomes (1)
Ultrasound measurement values
Ultrasound measurement values before and after the operation，include residual muscle thickness;length of cesarean scar defects;width of cesarean scar defects;height of cesarean scar defects
Measured: 3 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 posted8 Apr 2025
- Study start16 May 2025 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cesarean Scar DefectStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowu Huang, Fu Xing Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917014
- Sponsor's protocol ID
- 2024-11-2331
- Status last verified
- May 2025
- First submitted
- 25 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casadio P, Gubbini G, Morra C, Franchini M, Paradisi R, Seracchioli R. Channel-like 360 degrees Isthmocele Treatment with a 16F Mini-Resectoscope: A Step-by-step Technique. J Minim Invasive Gynecol. 2019 Nov-Dec;26(7):1229-1230. doi: 10.1016/j.jmig.2019.04.024. Epub 2019 May 3.
PubMed 31059782Casadio P, Raffone A, Alletto A, Filipponi F, Raimondo D, Arena A, La Rosa M, Virgilio A, Franceschini C, Gubbini G, Franchini M, Paradisi R, Lenzi J, Travaglino A, Mollo A, Carugno J, Seracchioli R. Postoperative morphologic changes of the isthmocele and clinical impact in patients treated by channel-like (360 degrees ) hysteroscopic technique. Int J Gynaecol Obstet. 2023 Jan;160(1):326-333. doi: 10.1002/ijgo.14387. Epub 2022 Aug 23.
PubMed 35929843Zhang NN, Wang GW, Yang Q. Endoscopic Treatment of Previous Cesarean Scar Defect in Women with Postmenstrual Bleeding: A Retrospective Cohort Study. J Invest Surg. 2021 Oct;34(10):1147-1155. doi: 10.1080/08941939.2020.1766161. Epub 2020 May 13.
PubMed 32404009Shapira M, Mashiach R, Meller N, Watad H, Baron A, Bouaziz J, Cohen SB. Clinical Success Rate of Extensive Hysteroscopic Cesarean Scar Defect Excision and Correlation to Histologic Findings. J Minim Invasive Gynecol. 2020 Jan;27(1):129-134. doi: 10.1016/j.jmig.2019.03.001. Epub 2019 Mar 8.
PubMed 30858053He Y, Zhong J, Zhou W, Zeng S, Li H, Yang H, Shan N. Four Surgical Strategies for the Treatment of Cesarean Scar Defect: A Systematic Review and Network Meta-analysis. J Minim Invasive Gynecol. 2020 Mar-Apr;27(3):593-602. doi: 10.1016/j.jmig.2019.03.027. Epub 2019 Nov 5.
PubMed 31698049
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Hysteroscopic "360°" Surgery for Improvement of Symptoms in Cesarean Scar Defects
- ClinicalTrials.gov ID
- NCT06917014
- Acronym / sponsor ID
- 2024-11-2331
- Conditions
- Cesarean Scar Defect
- Keywords
- Hysteroscopic "360°" Surgery, Cesarean Scar Defects
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 16 May 2025 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 8 Apr 2025 (actual)
- 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.
Patients with symptomatic Cesarean Scar Defect (CSD) who are expected to undergo hysteroscopic surgery will be randomly divided into the traditional hysteroscopic "channelization" treatment group and the hysteroscopic "360 °" Surgery group of cesarean diverticulum, and the improvement of postoperative clinical symptoms of the two groups will be compared. To evaluate the effectiveness of the two surgical methods.
The purpose of this study was to evaluate the improvement of symptoms of women with symptomatic cesarean diverticulum through a high-quality randomized controlled study, in order to provide high-level evidence-based medical evidence for clinical treatment.
Detailed description
- Study Design：This is a prospective, randomized controlled trial.
- Study population 120 patients diagnosed with Cesarean Scar Defect (CSD) will be prospectively recruited. Before the surgery all patients will undergo preoperative evaluations, including a detailed history of the menstrual pattern,any previous History of cesarean section, and reproductive history, as well as trans-vaginal ultrasonography and Three-dimensional SIS Ultrasound.
- Randomization: Randomization was performed electronically using SPSS statistical software version 26.0 (SPSS, Inc., Chicago, IL,USA) by the investigator.120 recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: the control group("channelization" group) and the experimental group("360°" group).
- Surgical technique: Hysteroscopic surgery will be performed in a standardized manner.The procedure will be performed under general anesthesia. Ultrasonographic guidance will be routinely used. The interference of "360°" group (the experimental group) including 60 CSD patients ,With the vaginoscopic approach, the isthmocele was localized; a high-frequency 90°angled circular loop electrode and pure cutting current of 100 W were used to resect the fibrotic tissue of the proximal (step 1) and distal (step 2) part of the niche. The investigators performed resection not only of the fibrotic tissue underneath the niche but also of the inflamed tissue placed around the niche and on the opposite site (the so-called channel-like 360° endocervical ablation). A high-frequency angled ball electrode was used to obtain focused coagulation of all residual inflamed tissue still present on the niche surface and on the cervical canal walls (step 3); the aim of this step is to facilitate the re-epithelialization of the cervical canal walls by the paraphysiological endocervical epithelium. The procedure was ended by controlling any bleeding of the endocervical vessels by reducing the inflow and pressure of the distending medium and by focused electrocauterization with a ball electrode (step 4).while the interference of "channelization" group (the control group) , With the vaginoscopic approach, the isthmocele was localized; a high-frequency 90°angled circular loop electrode and pure cutting current of 100 W were used to resect the fibrotic tissue of the proximal perform intrauterine adhesiolysis with bipolar electric needle electrode, part of the scar tissue removed by electronic loop when it is necessary.A angled ball electrode was used to obtain focused coagulation of proliferating blood vessels, inflammatory tissue, and ectopic endometrium in the diverticulum.In both arms, the endometrium tissue was removed and sent to pathology, followed by immunohistochemical CD138 examination
- Postoperative treatments All subjects will be treated with oral antibiotics for 3 days. Three-dimensional SIS Ultrasound will be carried out 3 months after the surgery.
- Follow up: Follow-up styles: the doctor's outpatient review, patients fill in questionnaires,telephone, WeChat and so on. Follow-up time:3 months and 6 months after the operation. Follow-up contents: the data measured by 3D-SIS,At the same time, the endometrium was taken again for immunohistochemical CD138 examination. Assessed the improvement of symptoms, including the improvement of prolonged menstrual period, the improvement of heavy menstruation, and the patient's postoperative satisfaction.
- Consent： All subjects will be given a detailed explanation of the study and sufficient time to consider their participation. A written consent form will be signed by the patient and retained in the records.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 360° | Experimental | Procedure: 360°The interference of the experimental group is to resect the fibrotic inflamed tissue of the proximal and distal part of the niche, a high-frequency angled ball electrode was used to obtain focused coagulation of all residual inflamed tissue still present on the niche surface and on the cervical canal walls, focused electrocauterization with a ball electrode controlling any bleeding of the endocervical vessels. |
| traditional | Other | Procedure: traditionalThe interference of the control group is to resect the fibrotic tissue of the proximal of the niche, use angled ball electrode coagulation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with surgical adaptation: changes in menstruation after cesarean section (prolonged menstrual period)
- No surgical contraindications;
- Age 18-45 years old;
- The thickness of residual muscle layer measured by ultrasound is greater than or equal to 2.5mm;
- Patients with symptoms that have not improved significantly for more than 1 month after oral short-acting contraceptive cycle treatment or who strongly require surgery;
Key exclusion criteria (2 listed)
- Patients with other diseases that may cause abnormal uterine bleeding (including endometrial polyps, endometrial hyperplasia, submucosal myoma, etc.) indicated by two-dimensional ultrasound
- There are contraindications of surgery: such as severe internal and surgical complications, pregnancy, reproductive tract infection, malignant tumor;
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 |
|---|---|---|
| 360°reset the proximal and distal part of the niche, widely 360° coagulation to restore and change the shape and size of niche, and ultimately improve symptoms of patients. | Procedure or surgery | 360° |
| traditionalreset the proximal part of the niche, and coagulation to restore and change the shape and size of niche, and ultimately improve symptoms of patients. | Procedure or surgery | traditional |
Primary outcome
Symptom change rate
Time frame: 6 months after surgery
Rate of change in abnormal bleeding before and after the operation
1 secondary outcome
Ultrasound measurement values
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 31059782Casadio P, Gubbini G, Morra C, Franchini M, Paradisi R, Seracchioli R. Channel-like 360 degrees Isthmocele Treatment with a 16F Mini-Resectoscope: A Step-by-step Technique. J Minim Invasive Gynecol. 2019 Nov-Dec;26(7):1229-1230. doi: 10.1016/j.jmig.2019.04.024. Epub 2019 May 3.
- Background: PubMed 35929843Casadio P, Raffone A, Alletto A, Filipponi F, Raimondo D, Arena A, La Rosa M, Virgilio A, Franceschini C, Gubbini G, Franchini M, Paradisi R, Lenzi J, Travaglino A, Mollo A, Carugno J, Seracchioli R. Postoperative morphologic changes of the isthmocele and clinical impact in patients treated by channel-like (360 degrees ) hysteroscopic technique. Int J Gynaecol Obstet. 2023 Jan;160(1):326-333. doi: 10.1002/ijgo.14387. Epub 2022 Aug 23.
- Background: PubMed 32404009Zhang NN, Wang GW, Yang Q. Endoscopic Treatment of Previous Cesarean Scar Defect in Women with Postmenstrual Bleeding: A Retrospective Cohort Study. J Invest Surg. 2021 Oct;34(10):1147-1155. doi: 10.1080/08941939.2020.1766161. Epub 2020 May 13.
- Background: PubMed 30858053Shapira M, Mashiach R, Meller N, Watad H, Baron A, Bouaziz J, Cohen SB. Clinical Success Rate of Extensive Hysteroscopic Cesarean Scar Defect Excision and Correlation to Histologic Findings. J Minim Invasive Gynecol. 2020 Jan;27(1):129-134. doi: 10.1016/j.jmig.2019.03.001. Epub 2019 Mar 8.
- Background: PubMed 31698049He Y, Zhong J, Zhou W, Zeng S, Li H, Yang H, Shan N. Four Surgical Strategies for the Treatment of Cesarean Scar Defect: A Systematic Review and Network Meta-analysis. J Minim Invasive Gynecol. 2020 Mar-Apr;27(3):593-602. doi: 10.1016/j.jmig.2019.03.027. Epub 2019 Nov 5.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 360° and traditional in people with Cesarean Scar Defect, run by Fu Xing Hospital, Capital Medical University.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowu Huang (+8613810828816, hxiaowu_fxyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom change rate (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?
On the ClinicalTrials.gov record for NCT06917014, which also lists 5 linked publications.
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 16 May 2025.