Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst

NCT06399744 | Completed

• 1 other identifier: sclerotherapy
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the role of sclerotherapy (injection of tetracycline or injection of Polidocanol - 95% hydroxypolyethoxydodecane and 5% ethanol -) in treatment of non-neoplastic ovarian cysts by, percutaneous trans-abdominal approach or trans-vaginal approach.

Conditions

Benign Ovarian Cyst

Keywords

sclerotherapy; cyst aspiration; non-neoplastic ovarian cysts

Outcome Measures

Primary Outcomes (1)

• role of sclerotherapy in treatment of non-neoplastic ovarian cysts

  The main outcome measure was the disappearance of the cyst and the avoidance of surgery. The cyst was considered resolved if follow-up revealed either no cystic lesion or only a follicle-like cyst no more than 30 mm in diameter.

  followed up from 1 month to 6 months

Study Arms (2)

trans-abdominal group

OTHER

Procedure: sclerotherapy

trans-vaginal group

OTHER

Procedure: sclerotherapy

Interventions

sclerotherapy PROCEDURE

injection of sclerosing agent (tetracycline or polidocanol) into ovarian cyst after aspiration of its contents

trans-abdominal group; trans-vaginal group

Eligibility Criteria

• Age: 15 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients were diagnosed with non-neoplastic ovarian cysts (i.e., simple, hemorrhagic, complicated, endometriotic cysts).
• All Patients from 15 to 48 years old.
• Size from (5 to 10 cm).
• Cyst wall thickness \< 5 mm.
• Negative tumor markers (Cancr Antigen125, Cancer Embryonic Antigen, Cancer Antigen19.9 \& alpha fetoprotein).
• Persisted for more than 3 months.
• Normal color Doppler blood flow analysis.
• Resistant to hormonal treatment COCs.
• Patients accepted to be enrolled in the study.

You may not qualify if:

• Family history of ovarian cancer.
• USG features suggesting malignancy like: multilocular, papillary projections or mural nodule, cyst wall thickness \>5mm, low Doppler indices (PI≤1 and or RI≤0.40, centrally located vessels, randomly dispersed vessels).
• Known allergy to sclerosing agent (tetracycline or Polidocanol).
• Bleeding tendency as (patients with platelet count \<50,000, patients with Uncorrected Coagulopathy with International Normalized Ratio \>1.5, or patients on antithrombotic therapy without stoppage of doses till 5 days before the procedure.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Asyut, Egypt

Location

MeSH Terms

Interventions

Sclerotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Khaled Abdallah

  Al-Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: September 1, 2022
• Primary Completion: January 30, 2024
• Study Completion: February 28, 2024
• Last Updated: May 6, 2024

Record last verified: 2022-10

Locations

EG (1)