Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.

NCT ID: NCT03429881

Last Updated: 2018-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-02-05

Brief Summary

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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.

Detailed Description

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Conditions

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Microparticle Endometriosis Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laparoscopic stripping ovarian endometriomas

Group Type ACTIVE_COMPARATOR

Stripping versus laser CO2

Intervention Type PROCEDURE

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

Laser CO2 treatment ovarian endometriomas

Group Type ACTIVE_COMPARATOR

Stripping versus laser CO2

Intervention Type PROCEDURE

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

Interventions

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Stripping versus laser CO2

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Francisco Carmona

OTHER

Sponsor Role lead

Responsible Party

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Francisco Carmona

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HCB/2015/0068

Identifier Type: -

Identifier Source: org_study_id

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