Preliminary Clinical Application Study of Saline Infusion Onohysterography in Structure of Cesarean Scar Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
Study Overview
Brief Summary
This study selected patients who underwent cesarean section and were scheduled to undergo Saline Infusion Sonohysterography (SIS) for evaluating the structure of the incision. Clinical characteristics and clinical symptoms were collected. Combined with hysteroscopy, MRI, conventional ultrasound and SIS examination results, the study analyzed the detection rate of cesarean section diverticula by SIS, the changes in diverticulum size and the diagnostic efficacy of residual muscle layer thickness at the incision site. The surgical methods and clinical symptom improvement of patients with CSD after surgery were followed up for half a year to one year. The study aimed to clarify the guiding value of SIS in clinical decision-making and patient prognosis for patients, and to analyze the etiological relationship between the true incidence of CSD and clinical complications. Thus, it provided evidence-based basis for clinical events of cesarean section surgery → CSD → CSD complications → surgical treatment of CSD → patient prognosis, promoting the progress of precise diagnosis and treatment of female reproductive health.
Detailed Description
Background and Rationale:
The precise assessment of the structure of the cesarean section incision is the core of achieving "individualized surgery". Through multi-dimensional analysis of anatomical structure, functional status, and patient needs, one can precisely select hysteroscopy, laparoscopy, or combined surgical methods, significantly improving symptom relief rate, diverticulum closure rate, and reducing the risks of recurrence and pregnancy complications. However, preoperative precise diagnosis is the prerequisite for treatment. The SIS technology can obtain a good acoustic window through a simple uterine cavity water injection method, clearly displaying the structure of the cesarean section incision, enhancing the diagnostic confidence of ultrasound doctors, providing more detailed diagnoses for patients and clinicians, and is expected to replace diagnostic hysteroscopy operations. In the future, it is necessary to promote the standardization of assessment and technology transformation, ultimately achieving the leap from "treatment based on symptoms" to "precise repair" of CSD, improving the long-term prognosis of patients.
Study Design and Methodology:
This is a single-center, prospective, observational cohort study. The objective is to To explore the diagnostic value of the acoustic contrast imaging technique using normal saline for the uterine cavity in the assessment of the incision structure after cesarean section.
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •More than 6 months after cesarean delivery;
- •Presenting with clinical symptoms-including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility;
- •Requiring saline infusion sonohysterography (SIS) to evaluate the cesarean scar.
Exclusion Criteria
- •Multiple cesarean deliveries;
- •Patients contraindicated for saline infusion sonohysterography (SIS), including pregnancy or suspected pregnancy, failure to meet vaginal hygiene criteria, inability to cooperate during the procedure, or suboptimal image quality;
- •Cases with incomplete clinical data or lost to follow-up.
Investigators
Li Zhang
Associate Chief Physician
Tang-Du Hospital