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

May 14, 2025 updated by: Xiaowu Huang, Fu Xing Hospital, Capital Medical University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Other: traditional
The interference of the control group is to resect the fibrotic tissue of the proximal of the niche, use angled ball electrode coagulation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom change rate
Time Frame: 6 months after surgery
Rate of change in abnormal bleeding before and after the operation
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound measurement values
Time Frame: 3 months after surgery
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
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Xing Hospital, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 16, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-11-2331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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