Endometriosis disease. Endometriosis
Conditions
Interventions
Intervention 1: Use of Hyaluronic Acid Gel as an Anti-Adhesive Agent During Surgery· Brand Name: Singclean· Manufacturer: Avije Teb Parsian· Active Ingredient: Sodium Hyaluronate· Pharmaceutical Form:
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Vaginal/rectal ultrasound confirmation of deep endometriosis no desire to become pregnant in the next 3 months candidate for surgical treatment of endometriosis age 18 to 45 years
Exclusion criteria
Exclusion criteria: Patients' unwillingness to continue participating in the study the presence of active infection pregnancy and breastfeeding cardiovascular diseases, gastrointestinal diseases, diseases involving the immune system such as lupus, etc inflammation of the genital tract past or present cancer positive serological evidence of previous or current hepatitis B and C, as well as HIV and HTLV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Variable: The extent of postoperative adhesions, assessed via ultrasound by a radiologist blinded to the patient’s group assignment, 3 to 6 months after surgery.Two outcomes are evaluated:1. A score is assigned based on the extent and severity of adhesions.2. Mobility assessment: The degree of freedom of movement of the ovaries and pelvic organs is examined. Timepoint: Ultrasound 3 to 6 months after gel injection. Method of measurement: ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Section 4: Study Outcome Variables4-1. Primary Outcome:The primary outcome is the main variable used to answer the research question and estimate the sample size.· Description: Incidence (occurrence) of new or recurrent pelvic adhesions after surgery.· Method and Timing of Measurement: This outcome will be assessed during the planned "second-look" laparoscopy, scheduled 4 to 5 months after the initial surgery.· Assessment Tool/System: Adhesion assessment will be performed by a blinded evaluator using a standardized pelvic adhesion scoring system. The most validated systems for this purpose include the following, which must be specified in the final protocol: · The revised American Fertility Society (r-AFS) adhesion scoring system (the adhesion component). · A dedicated Adhesion Scoring System (e.g., Modified Adhesion Scoring System).· Outcome Measure: Comparison of the mean (or median) adhesion score and the percentage of patients with no new adhesions between the intervention and control groups.4-2. Secondary Outcomes:Secondary outcomes measure complementary important results or side effects of the intervention.1. Pelvic Pain Severity: · Description: Change in the severity of endometriosis-related pain after surgery. · Method and Timing of Measurement: Using the Visual Analogue Scale (VAS) for pain from 0 (no pain) to 10 (worst pain imaginable). This assessment will be conducted preoperatively, 1 month postoperatively, and at the time of the second-look laparoscopy (4-5 months). · Outcome Measure: Comparison of changes in pain scores between the two groups over time.2. Health-Related Quality of Life: · Description: Change in the quality of life of patients with endometriosis. · Method and Timing of Measurement: Using a standardized endometriosis-specific quality of life questionnaire, preferably the Endometriosis Health Profile-30 (EHP-30) or its short version EHP-5. This assessment will be conducted preoperatively and 4-5 months postoperatively (concur | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Yazdi
Tehran University of Medical Sciences
Outcome results
None listed