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

ConditionCesarean Scar Defect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFu Xing Hospital, Capital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 360°

    Procedure/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.

  • traditional

    Procedure/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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: 360°Experimental treatment 1 intervention
Group B: traditionalOther 1 intervention

Trial outcomes

Primary outcomes

1

Symptom change rate

Rate of change in abnormal bleeding before and after the operation

Time frame
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

Time frame
3 months after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fu Xing Hospital, Capital Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: