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Conservative Endometrioma Surgery (BLAST)

Primary Purpose

Endometriosis Ovary, Endometrioma

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis Ovary

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.

Inclusion Criteria:

  • Age: 18 - 40 years (both inclusive)
  • Unilateral endometriotic cysts with a mean diameter of >=2.5cm and ≤8 cm, measured in 3 dimensions.
  • Presence of a contralateral endometrioma of ≤ 2cm is allowed
  • Complaining of infertility and/or pain
  • BMI ≤35
  • Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery

Exclusion Criteria:

  • Incomplete surgery for the pelvis
  • Contra-indication for the use of contraception (combined or Progesteron only)
  • Use of GnRH analogues preoperatively and in the first 3 months postoperatively
  • (History of) hysterectomy
  • Prior unilateral oophorectomy
  • Pituitary/hypothalamic disorders
  • Suspected malignancy
  • Contralateral endometrioma of >2 cm
  • AMH <0.7 preoperatively
  • Pregnancy

Sites / Locations

  • GZA Sint-AugustinusRecruiting
  • Cliniques universitaires Saint-LUC (UCL)Recruiting
  • UZLeuvenRecruiting
  • CHR La CitadelleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The combined technique

CO2 laser vaporization only

Arm Description

First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.

CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.

Outcomes

Primary Outcome Measures

AMH levels 3 months postoperatively
To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).

Secondary Outcome Measures

Full Information

First Posted
October 31, 2019
Last Updated
June 17, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
GZA Ziekenhuizen Campus Sint-Augustinus, Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT04151433
Brief Title
Conservative Endometrioma Surgery
Acronym
BLAST
Official Title
BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
GZA Ziekenhuizen Campus Sint-Augustinus, Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation. The 2 conservatives techniques used are: The combined technique CO2 laser vaporization only Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Ovary, Endometrioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The combined technique
Arm Type
Active Comparator
Arm Description
First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.
Arm Title
CO2 laser vaporization only
Arm Type
Active Comparator
Arm Description
CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.
Intervention Type
Procedure
Intervention Name(s)
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
Intervention Description
cf. different arms
Primary Outcome Measure Information:
Title
AMH levels 3 months postoperatively
Description
To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).
Time Frame
3 months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts. Inclusion Criteria: Age: 18 - 40 years (both inclusive) Unilateral endometriotic cysts with a mean diameter of >=2.5cm and ≤8 cm, measured in 3 dimensions. Presence of a contralateral endometrioma of ≤ 2cm is allowed Complaining of infertility and/or pain BMI ≤35 Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery Exclusion Criteria: Incomplete surgery for the pelvis Contra-indication for the use of contraception (combined or Progesteron only) Use of GnRH analogues preoperatively and in the first 3 months postoperatively (History of) hysterectomy Prior unilateral oophorectomy Pituitary/hypothalamic disorders Suspected malignancy Contralateral endometrioma of >2 cm AMH <0.7 preoperatively Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Tomassetti, MD, PhD
Phone
+3216340825
Email
carla.tomassetti@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Celine Bafort, MD
Phone
+3216340088
Email
celine.bafort@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Tomassetti, MD, PhD
Organizational Affiliation
Leuven University Fertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
GZA Sint-Augustinus
City
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brecht Geysenbergh, MD
First Name & Middle Initial & Last Name & Degree
Brecht Geysenbergh, MD
Facility Name
Cliniques universitaires Saint-LUC (UCL)
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Beausaert
First Name & Middle Initial & Last Name & Degree
Jean-Luc Squifflet, MD, PhD
First Name & Middle Initial & Last Name & Degree
Christine Wyns, MD, PhD
Facility Name
UZLeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Bafort, MD
Email
celine.bafort@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Carla Tomassetti, MD, PhD
First Name & Middle Initial & Last Name & Degree
Celine Bafort, MD
Facility Name
CHR La Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Timmermans, Msc
First Name & Middle Initial & Last Name & Degree
Michelle Nisolle, MD, Phd
First Name & Middle Initial & Last Name & Degree
Linda Tebache, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Conservative Endometrioma Surgery

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