The Use of plasmaJet During Operative Laparoscopy for Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Device: PlasmaJet

• Registration Number: NCT04394468
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Endometriosis is a condition where functional endometrial tissue is present outside the uterus. It usually locates in the pelvis, which often includes the ovaries. One of the main concerns when performing surgery is to maintain fertility.

Nevertheless, a disadvantage of using monopolar and bipolar instruments for laparoscopic excision or coagulation of endometriosis lesions is the energy / thermal distribution that can cause damage to the surrounding healthy tissue. Therefore, the use of ultrasound, laser or plasma energy can potentially reduce damage to surrounding tissues and prevent adhesion formation. In addition, ablation of the internal surface of endometriomas can be an effective alternative to cystectomy.

The PlasmaJet system uses argon plasma which is released as kinetic, light and / or thermal energy. In this way the instrument can be applied within three functions, namely cutting, vaporizing and coagulating. Moreover, plasma will dissipate very quickly upon contact with tissue which consequently allows a controlled depth of tissue penetration. Thirdly, pure plasma energy differs from conventional electrosurgery since no electrical current will be spread through the tissue and therefore the thermal effect at surrounding tissues remains minimal.

The aim of this pilot study is to investigate the feasibility, effectiveness and safety of plasma energy in the treatment of endometriosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-07
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

• Women between 18 and 45 years old.
• The presence of endometriosis; requiring surgical laparoscopy.

Exclusion Criteria

• Women younger than 18 years.
• Women older than 45 years.
• Women who are scheduled for surgical laparoscopy where the removal of the uterus and / or ovaries is needed.
• Women who do not give written permission to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient group	PlasmaJet	Data is collected from women (18-45y) with endometriosis (superficial and / or deep infiltrating endometriosis) where the preferred treatment is a laparoscopic intervention at UZ Gent.

Primary Outcome Measures

Name	Time	Method
feasibility of the PlasmaJet instrument	During laparoscopic surgery	The surgeon's satisfaction with the use of plasma energy (5-point Likert scale).
safety of the PlasmaJet instrument	During laparoscopic surgery until six weeks after surgery	- Postoperative pain scores (VAS) (2 hours postoperatively, maximum pain scores during the days after surgery until the patient is discharged). Hereby the pain score is registered every hour during the stay in the PACU (Post-anesthesia care department). Afterwards, the pain score is recorded every four hours.
effectiveness of the PlasmaJet instrument	During laparoscopic surgery	- EFI score (Clinical instrument to predict pregnancy rates without IVF (ART) in patients after endometriosis surgery).

Trial Locations

Locations (1)

University hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium