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Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.

F

Francisco Carmona

Status

Completed

Conditions

Laparoscopy
Endometriosis
Microparticle

Treatments

Procedure: Stripping versus laser CO2

Study type

Interventional

Funder types

Other

Identifiers

NCT03429881
HCB/2015/0068

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

33 participants in 2 patient groups

Laparoscopic stripping ovarian endometriomas
Active Comparator group
Treatment:
Procedure: Stripping versus laser CO2
Laser CO2 treatment ovarian endometriomas
Active Comparator group
Treatment:
Procedure: Stripping versus laser CO2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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