NCT01596985

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) .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

2.5 years

First QC Date

May 9, 2012

Last Update Submit

May 11, 2012

Conditions

Ovarian Endometrioma

Keywords

EndometriomaEndometriosisCystectomyAblationPlasma energy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months postoperatively

Secondary Outcomes (2)

  • Decrease in ovarian antral follicles count (AFC)

    3 months postoperatively

  • Antimullerian Hormone level (AMH)

    3 months postoperatively

Study Arms (2)

Ablation using the PlasmaJet system

EXPERIMENTAL

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.

Procedure: Ablation using the PlasmaJet system

Cystectomy

ACTIVE COMPARATOR

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).

Procedure: Cystectomy

Interventions

Ablation using the PlasmaJet systemPROCEDURE

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.

Also known as: Ovarian cyst ablation, Ablation by plasma energy
Ablation using the PlasmaJet system
CystectomyPROCEDURE

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).

Also known as: Cyst excision, Ovarian stripping
Cystectomy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital

Clermont-Ferrand, Auvergne, 63033, France

RECRUITING

University Hospital

Rouen, Seine-Maritime, 76031, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25392649DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Horace Roman, MD, PhD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Horace Roman, MD PhD

CONTACT

0033232888643Horace.Roman@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 11, 2012

Study Start

November 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

FR(2)