Protocol summary
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Study aim
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General aims:
To determine the safety and effectiveness of Radiofrequency ablation (RFA) of abdominal wall endometriosis (AWE)
Specific aims:
1. Evaluation of the safety of RFA of AWE
2. Evaluation of the effectiveness of RFA of AWE in reducing the volume of the lesions and pain caused by AWE lesions within 6 months after treatment.
4. Determining the rate of recurrence and complications caused by RFA of AWE within 6 months after the treatment.
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Design
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The study is a phase 2 clinical trial with 10 patients without a control group.
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Settings and conduct
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In this phase 2 clinical trial, patients with abdominal wall endometriosis who were referred to Imam Hussein Hospital from November 2022 for whom surgical treatment was not suitable or the patient personally refused to accept surgical treatment, after understanding all aspects of the treatment including the experimental nature of the treatment method, possible risks, and complications and obtaining written consent, are treated by Radiofrequency ablation for AWE lesions.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Abdominal Wall Endometriosis (AWE) 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
Exclusion criteria: Patients with more than 1 AWE lesion
AWE lesion volume of over 50 cc
Past surgical history of resection of AWE
Past medical history of heart failure
Allergy to cephalexin and lidocaine
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Intervention groups
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After hospitalization, the patient is subjected to radiofrequency ablation of abdominal wall endometriosis lesions under general anesthesia.
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Main outcome variables
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The volume of abdominal wall endometriosis lesions before and after treatment; The score of pain in the lesion site before and after treatment
General information
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Reason for update
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During the study, it was necessary to modify the inclusion and exclusion criteria for a group of patients with specific clinical criteria due to the differences in the patients. So the results of this study could be reliable for patients with these criteria and further studies could evaluate the efficacy of this method in other populations.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220219054066N1
Registration date:
2022-09-29, 1401/07/07
Registration timing:
prospective
Last update:
2023-07-19, 1402/04/28
Update count:
1
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Registration date
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2022-09-29, 1401/07/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-10-27, 1401/08/05
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Expected recruitment end date
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2022-11-26, 1401/09/05
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Actual recruitment start date
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2022-10-27, 1401/08/05
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Actual recruitment end date
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2022-12-15, 1401/09/24
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Trial completion date
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2023-06-22, 1402/04/01
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Scientific title
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Safety and efficacy of Radiofrequency ablation of abdominal wall endometriosis
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Public title
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Radiofrequency ablation of abdominal wall endometriosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
10
Actual sample size reached:
10
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-06, 1401/06/15
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Ethics committee reference number
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IR.ACECR.AVICENNA.REC.1401.006
Health conditions studied
1
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Description of health condition studied
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Abdominal wall endometriosis
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ICD-10 code
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N80.9
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ICD-10 code description
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Endometriosis, unspecified
Primary outcomes
1
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Description
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Pain score on Visual Analogue Scale
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Timepoint
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Pain score at the beginning of the study and 30, 90 and 180 days after treatment
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Method of measurement
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Visual Analogue Scale
2
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Description
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The volume of the lesions in abdominal Ultrasound
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Timepoint
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The volume of the lesions at the beginning of the study and 30, 90 and 180 days after treatment
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Method of measurement
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Abdominal ultrasound
Intervention groups
1
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Description
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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.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iranian academic center for education culture and research
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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
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When the data will become available and for how long
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The access to data is available 6 months after the project results are published.
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To whom data/document is available
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The data obtained from this study will be available to researchers who intend to design a similar study.
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Under which criteria data/document could be used
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It is possible to use the data to assess the response to treatment and perform analyzes that compare the means of the variables.
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From where data/document is obtainable
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Researchers contact Seyed Ali Forouzannia through the email below.
s.ali.forouzannia@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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