Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.
Primary Purpose
Microparticle, Endometriosis, Laparoscopy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Stripping versus laser CO2
Sponsored by
About this trial
This is an interventional basic science trial for Microparticle
Eligibility Criteria
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.
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic stripping ovarian endometriomas
Laser CO2 treatment ovarian endometriomas
Arm Description
Outcomes
Primary Outcome Measures
Microparticle levels after two laparoscopic treatments of ovarian endometriomas
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429881
Brief Title
Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.
Official Title
Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma: a Pilot, Prospective, Randomized Study Comparing Stripping With CO2 Laser Vaporization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
February 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Carmona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microparticle, Endometriosis, Laparoscopy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic stripping ovarian endometriomas
Arm Type
Active Comparator
Arm Title
Laser CO2 treatment ovarian endometriomas
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Stripping versus laser CO2
Intervention Description
Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
Primary Outcome Measure Information:
Title
Microparticle levels after two laparoscopic treatments of ovarian endometriomas
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication in an indexed journal
IPD Sharing Time Frame
Within 2018
Learn more about this trial
Microparticle Generation After Laparoscopic Surgical Treatment for Endometrioma.
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