Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.

NCT03429881 | Completed

• 1 other identifier: HCB/2015/0068
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Study objective: To evaluate serial generation of microparticles (MPs) after laparoscopic stripping or CO2 laser vaporization in surgical treatment of patients with ovarian endometrioma (OE). Design: A prospective, randomized, blinded, pilot study, including 33 patients. Setting: Tertiary university hospital from April 2015 to June 2017. Patients: 33 women with unilateral OE undergoing laparoscopic surgery. Intervention: Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE. Measurements and Main results: Blood samples were collected before surgery, and at 2 hours, 24 hours, 1 month, and 3 months after surgery. MPs generation curve after ovarian endometrioma surgery was performed.

Conditions

Microparticle; Endometriosis; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Microparticle levels after two laparoscopic treatments of ovarian endometriomas

  1 month

Study Arms (2)

Laparoscopic stripping ovarian endometriomas

ACTIVE COMPARATOR

Procedure: Stripping versus laser CO2

Laser CO2 treatment ovarian endometriomas

ACTIVE COMPARATOR

Procedure: Stripping versus laser CO2

Interventions

Stripping versus laser CO2 PROCEDURE

Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

Laparoscopic stripping ovarian endometriomas; Laser CO2 treatment ovarian endometriomas

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 40 years and unilateral symptomatic OEs ≥3 cm.

You may not qualify if:

• previous pelvic surgery, history of cancer, suspected malignancy, presurgical suspicion or evidence of deep endometriosis, presurgical suspicion or evidence of premature ovarian failure, and the use of estrogen suppressive drugs, including oral contraceptives, GnRH-agonists, progestins, or danazol in the preceding 3 months. We excluded patients with suspicion of deep endometriosis according to an extensive preoperative work-up (including magnetic resonance imaging when necessary) routinely performed in such patients.

Sponsors & Collaborators

• Francisco Carmona: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: February 5, 2018
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 2018

Locations

ES (1)