The Use of plasmaJet During Operative Laparoscopy for Endometriosis

NCT04394468 | Completed

• 1 other identifier: EC/2019/1742
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (8)

• feasibility of the PlasmaJet instrument

  The surgeon's satisfaction with the use of plasma energy (5-point Likert scale).

  During laparoscopic surgery

• effectiveness of the PlasmaJet instrument

  \- Whether or not to use additional instruments to achieve hemostasis (monopolar or bipolar coagulation) and / or complete resection of the lesions (monopolar or ultrasonic energy).

  During laparoscopic surgery

• effectiveness of the PlasmaJet instrument

  \- completeness of resection or ablation, with a detailed description of deleted / ablated lesions.

  During laparoscopic surgery

• effectiveness of the PlasmaJet instrument

  \- EFI score (Clinical instrument to predict pregnancy rates without IVF (ART) in patients after endometriosis surgery).

  During laparoscopic surgery

• safety of the PlasmaJet instrument

  \- Need for conversion to laparotomy.

  During laparoscopic surgery until six weeks after surgery

• safety of the PlasmaJet instrument

  \- Serious complications up to 6 weeks after the operation. The most common complications that can occur with surgical laparoscopy are bleeding, damage to the surrounding tissues / structures and the formation of adhesions.

  During laparoscopic surgery until six weeks after surgery

• safety of the PlasmaJet instrument

  \- Duration (in hours) of hospital stay after the procedure.

  During laparoscopic surgery until six weeks after surgery

• safety of the PlasmaJet instrument

  \- 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.

  During laparoscopic surgery until six weeks after surgery

Study Arms (1)

patient group

OTHER

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.

Device: PlasmaJet

Interventions

PlasmaJet DEVICE

Data will be collected during two contact moments, in particular during her admission for surgical laparoscopy, and during her postoperative check-up. Both of these are standard of care. No additional questionnaires will be taken. During the admission the postoperative pain scoreswill be monitored and collected. The duration of her stay in the hospital will also be recorded. During the postoperative check-up, which takes usually place six weeks after the surgery, complications will registered.

patient group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Tjalina Hamerlynck

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: May 19, 2020
• Study Start: February 7, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

BE (1)