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IRCT20220219054066N1 IRCT 2022-09-29 Iranian academic center for education culture and research Radiofrequency ablation of abdominal wall endometriosis Safety and efficacy of Radiofrequency ablation of abdominal wall endometriosis 2022-10-27 anticipated 10 Complete https://irct.ir/trial/66067 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Abdominal wall endometriosis. After determining the volume of the lesions with ultrasound, the patients with receive general anesthesia and local anesthesia will be achieved with a subcutaneous injection of 1% Lidocaine. Then Radiofrequency ablation will be performed. The heating process will last 60-120 seconds, and the temperature will reach 90-95 degrees. After the ablation of each section, the transducer will move, and a nearby section will be treated similarly until the entire lesion is ablated. The patient will be closely monitored in the recovery room for six hours, and if no complications occurred, they will be sent home the same night. Prophylactic antibiotic therapy is Cephalexin 500 mg every six hours for three days.. Yes - There is a plan to make this available What will be shared: Publishable data from this study include the following: age of patients, pain level before and after treatment based on visual analog scale, the volume of abdominal wall endometriosis lesions before and after treatment When: The access to data is available 6 months after the project results are published. To whom: The data obtained from this study will be available to researchers who intend to design a similar study. Conditions: It is possible to use the data to assess the response to treatment and perform analyzes that compare the means of the variables. Where to obtain: Researchers contact Seyed Ali Forouzannia through the email below. s.ali.forouzannia@gmail.com How to obtain: The researcher must first send the proposal and approval of the ethics committee to Seyed Ali Forouzannia, and after review, the information will be provided to him within one month. Comments:
public Seyed Ali Forouzannia
No. 54, Saeidi Ave., Bahonar St., Niavaran, Tehran, Iran
Tehran Iran (Islamic Republic of) 1954964371 +98 21 2613 2119 s.ali.forouzannia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyed Aliakbar Mahdavi Anari
Shahid Beheshti University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 0098 21 238710000 mahdavi0ali@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Abdominal Wall Endometriosis diagnosis no history of abdominal wall surgery over the past three months patients without severe comorbidities, such as hypertension or diabetes patients could tolerate 1-2 hours under general anesthesia 18 years no limit Female Patients with more than 1 abdominal wall endometriosis lesion Abdominal wall endometriosis lesion volume of over 50 cc Past surgical history of resection of abdominal wall endometriosis Past medical history of heart failure Allergy to cephalexin and lidocain N80.9 Endometriosis, unspecified Treatment - Surgery After determining the volume of the lesions with ultrasound, the patients with receive general anesthesia and local anesthesia will be achieved with a subcutaneous injection of 1% Lidocaine. Then Radiofrequency ablation will be performed. The heating process will last 60-120 seconds, and the temperature will reach 90-95 degrees. After the ablation of each section, the transducer will move, and a nearby section will be treated similarly until the entire lesion is ablated. The patient will be closely monitored in the recovery room for six hours, and if no complications occurred, they will be sent home the same night. Prophylactic antibiotic therapy is Cephalexin 500 mg every six hours for three days. Pain score on Visual Analogue Scale. Timepoint: Pain score at the beginning of the study and 30, 90 and 180 days after treatment. Method of measurement: Visual Analogue Scale. The volume of the lesions in abdominal Ultrasound. Timepoint: The volume of the lesions at the beginning of the study and 30, 90 and 180 days after treatment. Method of measurement: Abdominal ultrasound. Iranian academic center for education culture and research Approved 2022-09-06 Research Ethics Committees of Avicenna Research Institute Avicenna Research Institute, Shahid Beheshti University, Tehran Tehran Tehran Iran (Islamic Republic of)