Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.

Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma: a Pilot, Prospective, Randomized Study Comparing Stripping With CO2 Laser Vaporization

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis; Laparoscopy; Microparticle
• Intervention / Treatment: Procedure: Stripping versus laser CO2

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic stripping ovarian endometriomas	Procedure: Stripping versus laser CO2; Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
Active Comparator: Laser CO2 treatment ovarian endometriomas	Procedure: Stripping versus laser CO2; Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Microparticle levels after two laparoscopic treatments of ovarian endometriomas	1 month

Collaborators and Investigators

• Sponsor: Francisco Carmona

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): February 5, 2018
• Study Completion (Actual): February 5, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: HCB/2015/0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication in an indexed journal
• IPD Sharing Time Frame: Within 2018
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No