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Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy

Primary Purpose

Ovarian Endometrioma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ablation using the PlasmaJet system
Cystectomy
Sponsored by
Plasma Surgical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Endometrioma focused on measuring Endometrioma, Endometriosis, Cystectomy, Ablation, Plasma energy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 45 years;
  • Surgery required by pelvic pain or infertility related to endometriosis;
  • Clinical and imaging data proving unilateral ovarian endometrioma which diameter exceeds 30 mm.

Exclusion Criteria:

  • Previous surgery on ovaries or IVF procedures;
  • Bilateral endometriomas;
  • Pregnancy
  • Woman not French speaker.

Sites / Locations

  • University HospitalRecruiting
  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ablation using the PlasmaJet system

Cystectomy

Arm Description

Origin of cyst invagination is identified after lysis of adhesions between ovary and adjacent broad ligament, leading to characteristic "chocolate fluid" evacuation. Surgeon then attempts to turn cyst completely inside out via original invagination site of diameter averaging 1 to 2cm. Ablation of cyst's inner surface is performed using the PlasmaJet system in coagulation mode set at 40, at distance averaging 5mm from tip of handpiece, and with exposure time limited to 1 to 2s on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and corresponding peritoneal implants on adjacent broad ligament. When cyst reversion is not feasible, surgeon progressively exposes cyst interior to guide plasma beam at an angle perpendicular to the inner surface.

Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C).

Outcomes

Primary Outcome Measures

Loss of ovarian volume
Evaluation of ovarian volumes of both the operated and the contralateral healthy ovary using a tridimensional ultrasound by vaginal route. The volume of each ovary expressed in cm³ was estimated using the formula D1 x D2 x D3 x π / 6. The Mann and Whitney test is performed to compare measurements made on the operated ovaries vs. those made on the contralateral ovaries.

Secondary Outcome Measures

Decrease in ovarian antral follicles count (AFC)
Evaluation of antral follicle counts in both the operated and the contralateral, healthy ovary, using tridimensional ultrasound. The Mann and Whitney test is performed to compare the decrease in AFC depending on surgical procedure.
Antimullerian Hormone level (AMH)
AMH level are measured before and 3 months after the surgery to evaluate the decrease in AMH level depending on surgical technique.

Full Information

First Posted
May 9, 2012
Last Updated
May 11, 2012
Sponsor
Plasma Surgical Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01596985
Brief Title
Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy
Official Title
Prospective, Monocentric Study Comparing Cystectomy to PlasmaJet Ablation in the Surgical Management of Ovarian Endometriomas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Plasma Surgical Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound. Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers. Patients: Fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma > 30 mm in diameter. Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian tissue sparing cystectomy. Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (AFC) .
Detailed Description
The management of ovarian endometriomas in women wishing to conceive remains challenging. Recent data suggest that excising endometriomas by ovarian tissue sparing cystectomy does not avoid inadvertent removal of ovarian parenchyma surrounding the cyst, particularly in enlarged cysts. Although several authors question whether the ovarian parenchyma immediately surrounding the cyst may still be functional, there is little doubt that postoperative fertility could be significantly impaired by loss of ovarian cortex and provokes the question as to whether pregnancy should be initiated before performing a cystectomy, whenever this scenario is possible. However ovarian surgery cannot always be delayed to the postpartum period, numerous women require endometrioma management while not seeking an immediate pregnancy and still wish to conserve their procreative capabilities. After a period of some years during which cystectomy appeared to be the best surgical technique in the treatment of ovarian endometriomas in women wishing to become pregnant, recent data have suggested that ablation of the inner layer of the endometrioma may be a valuable alternative technique, as long as the energy employed avoids thermal diffusion to surrounding ovarian tissue. The Department of Gynecology at the University Hospital in Rouen, France have introduced ablation by plasma energy using the PlasmaJet system (Plasma Surgical Ltd, Abingdon, UK) and have already been able to report encouraging results based on non comparative pilot studies and on retrospective "before and after" comparative study. The aim of the study is to prospectively compare loss of ovarian parenchyma and decrease in antral follicle count (AFC) following ovarian endometrioma ablation using plasma energy versus cystectomy, when performed by only two expert surgeons. Postoperative examination is carried out by 3D ultrasound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma
Keywords
Endometrioma, Endometriosis, Cystectomy, Ablation, Plasma energy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation using the PlasmaJet system
Arm Type
Experimental
Arm Description
Origin of cyst invagination is identified after lysis of adhesions between ovary and adjacent broad ligament, leading to characteristic "chocolate fluid" evacuation. Surgeon then attempts to turn cyst completely inside out via original invagination site of diameter averaging 1 to 2cm. Ablation of cyst's inner surface is performed using the PlasmaJet system in coagulation mode set at 40, at distance averaging 5mm from tip of handpiece, and with exposure time limited to 1 to 2s on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and corresponding peritoneal implants on adjacent broad ligament. When cyst reversion is not feasible, surgeon progressively exposes cyst interior to guide plasma beam at an angle perpendicular to the inner surface.
Arm Title
Cystectomy
Arm Type
Active Comparator
Arm Description
Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C).
Intervention Type
Procedure
Intervention Name(s)
Ablation using the PlasmaJet system
Other Intervention Name(s)
Ovarian cyst ablation, Ablation by plasma energy
Intervention Description
Ablation of the inner surface of the cyst is then performed using the PlasmaJet system in coagulation mode set at 40, at a distance averaging 5 mm from the tip of the handpiece, and with an exposure time limited to 1 to 2 seconds on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and the corresponding peritoneal implants on the adjacent broad ligament.
Intervention Type
Procedure
Intervention Name(s)
Cystectomy
Other Intervention Name(s)
Cyst excision, Ovarian stripping
Intervention Description
Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic "chocolate fluid" evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C).
Primary Outcome Measure Information:
Title
Loss of ovarian volume
Description
Evaluation of ovarian volumes of both the operated and the contralateral healthy ovary using a tridimensional ultrasound by vaginal route. The volume of each ovary expressed in cm³ was estimated using the formula D1 x D2 x D3 x π / 6. The Mann and Whitney test is performed to compare measurements made on the operated ovaries vs. those made on the contralateral ovaries.
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Decrease in ovarian antral follicles count (AFC)
Description
Evaluation of antral follicle counts in both the operated and the contralateral, healthy ovary, using tridimensional ultrasound. The Mann and Whitney test is performed to compare the decrease in AFC depending on surgical procedure.
Time Frame
3 months postoperatively
Title
Antimullerian Hormone level (AMH)
Description
AMH level are measured before and 3 months after the surgery to evaluate the decrease in AMH level depending on surgical technique.
Time Frame
3 months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 45 years; Surgery required by pelvic pain or infertility related to endometriosis; Clinical and imaging data proving unilateral ovarian endometrioma which diameter exceeds 30 mm. Exclusion Criteria: Previous surgery on ovaries or IVF procedures; Bilateral endometriomas; Pregnancy Woman not French speaker.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horace Roman, MD PhD
Phone
0033232888643
Email
Horace.Roman@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horace Roman, MD, PhD
Organizational Affiliation
University Hospital, Rouen, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Clermont Ferrand
State/Province
Auvergne
ZIP/Postal Code
63033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Canis, MD PhD
Phone
+33473750750
Email
mcanis@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Michel Canis, MD
First Name & Middle Initial & Last Name & Degree
Jean-Luc Pouly, MD
First Name & Middle Initial & Last Name & Degree
Nicolas Bourdel, MD
Facility Name
University Hospital
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horace Roman, MD PhD
Phone
+33232888643
Email
horace.roman@gmail.com
First Name & Middle Initial & Last Name & Degree
Horace Roman, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25392649
Citation
Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3):e2014.00002. doi: 10.4293/JSLS.2014.00002.
Results Reference
derived

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Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy

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