Hysteroscopic "360°" Surgery for Improvement of Symptoms in Cesarean Scar Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2029-11-30

Brief Summary

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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.

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Detailed Description

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1. Study Design：This is a prospective, randomized controlled trial.
2. 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.
3. 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).
4. 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
5. 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.
6. 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.
7. 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

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Cesarean Scar Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

360°

Intervention Type PROCEDURE

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.

traditional

The interference of the control group is to resect the fibrotic tissue of the proximal of the niche, use angled ball electrode coagulation.

Group Type OTHER

traditional

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

traditional

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No