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

NCT06917014 | Not Yet Recruiting

• 1 other identifier: 2024-11-2331
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Cesarean Scar Defect

Keywords

Hysteroscopic "360°" Surgery; Cesarean Scar Defects

Outcome Measures

Primary Outcomes (1)

• Symptom change rate

  Rate of change in abnormal bleeding before and after the operation

  6 months after surgery

Secondary Outcomes (1)

• Ultrasound measurement values

  3 months after surgery

Study Arms (2)

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.

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.

Procedure: traditional

Interventions

360° 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.

360°

traditional 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.

traditional

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Related Publications (5)

• 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.

  PMID: 31059782 BACKGROUND

• Casadio 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.

  PMID: 35929843 BACKGROUND

• Zhang 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.

  PMID: 32404009 BACKGROUND

• Shapira 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.

  PMID: 30858053 BACKGROUND

• He 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.

  PMID: 31698049 BACKGROUND

Central Study Contacts

Xiaowu Huang

CONTACT

+8613810828816; hxiaowu_fxyy@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 8, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share