Endometriosis
Conditions
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.
Interventions
DEVICEPlasmaJet
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.
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the PlasmaJet instrument | During laparoscopic surgery | The surgeon's satisfaction with the use of plasma energy (5-point Likert scale). |
| effectiveness of the PlasmaJet instrument | During laparoscopic surgery | \- 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). |
| safety of the PlasmaJet instrument | During laparoscopic surgery until six weeks after surgery | \- Need for conversion to laparotomy. |
Countries
Belgium
Outcome results
None listed