Ovarian Endometrioma Ablation Using Plasma Energy Versus Cystectomy

Ovarian Endometrioma Clinical Trial

Official title:

Prospective, Monocentric Study Comparing Cystectomy to PlasmaJet Ablation in the Surgical Management of Ovarian Endometriomas

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01596985
• Other study ID #: P.S.PJ.6.10.GYN
• Status: Unknown status
• Phase: Phase 2
• First received: May 9, 2012
• Last updated: May 11, 2012
• Start date: November 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2012
• Source: Plasma Surgical Inc
• Contact: Horace Roman, MD PhD
• Phone: 0033232888643
• Email: Horace.Roman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Endometrioma

Intervention

Procedure:
• Ablation using the PlasmaJet system
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.
• Cystectomy
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).

Locations

Country	Name	City	State
France	University Hospital	Clermont Ferrand	Auvergne
France	University Hospital	Rouen	Seine-Maritime

Sponsors (1)

Lead Sponsor	Collaborator
Plasma Surgical Inc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 p / 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	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.	3 months postoperatively
Secondary	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.	3 months postoperatively