Diathermy

This study is called the PlaComOv-study. It is an acronym for ‘Will the use of the PLAsmajet device improve the rate of COMplete cytoreductive surgery for advanced stage OVarian cancer.
In this study, 330 patients with a FIGO IIIB-IV epithelial ovarian cancer, carcinoma of the fallopian tube or extra-ovarian epithelial ovarian cancer(peritoneal cancer) in whom the surgical goal is to achieve complete cytoreduction will be included. Patients should to be fit for CCS and chemotherapy.
Patients from the following Dutch hospitals may be included: Albert Schweitzer (Dordrecht), Bravis (Bergen op Zoom), Catharina Cancer Institute (Eindhoven), Erasmus MC (Rotterdam), Franciscus Gasthuis and Vlietland (Rotterdam), Groene Hart Hospital (Gouda), Haags Medisch Centrum (Den Haag), Haga Hospital (Den Haag), Leids University MC (Leiden), Medisch Spectrum Twente (Enschede), Reinier de Graaf Groep (Delft).
All surgeons are trained and certified in the use of PlasmaJet during the preparation of the study.
This study will compare the complete cytoreductive surgery rate when using electrocoagulation only (standard) with that achieved with additional use of the PlasmaJet Surgical Device (intervention). We expect that use of the PlasmaJet during surgery will result in a higher rate of complete cytoreduction and fewer colostomies [14 –20 (link)].
Standard therapy is primary cytoreductive (upfront) surgery followed by chemotherapy, or neoadjuvant chemotherapy followed by interval cytoreductive surgery. Standard chemotherapy comprises of 6 cycles of carboplatin and paclitaxel, with a duration of 21 days for each cycle [1 ]. In upfront cytoreductive surgery, all 6 cycles of chemotherapy are given after surgery. In interval cytoreductive surgery, 3 cycles of chemotherapy are administered prior to surgery and 3 cycles thereafter. Patients from both the upfront and interval cytoreductive groups may be included.
The standard of care is to reach complete cytoreduction in all women who are fit to undergo extensive surgery. This radical surgery may involve bowel surgery sometimes including colostomy. Electrocoagulation (Diathermy, LigaSure), scalpel and scissors are used during conventional surgery to remove visible tumour and to dissect tumour tissue from peritoneal surfaces. The disadvantage of electrocoagulation is the lateral thermal spread and the depth of tissue destruction, which render it unsuitable for use on the intestines. Electrocoagulation (Diathermy, LigaSure), scalpel, scissors and PlasmaJet are used when indicated during surgery in the intervention arm.

Investigations were performed on 20 sexually immature female pigs of the Large White Polish breed (approximately 8 weeks old, weighing ca. 20 kg) divided into 4 groups: control animals (C group, n = 5), acetylsalicylic acid treated (ASA group, n = 5), the partial stomach resection group (RES group, n = 5), and animals with hydrochloric acid infusion (HCl group, n = 5). All animals were kept under standard laboratory conditions with admission to species-specific chow and water ad libitum. All surgical procedures were carried out in accordance with the Local Ethical Committee in Olsztyn (decision number 05/2010). All possible efforts were made to minimize animal suffering.
Animals were treated with azaperone (Stresnil, Janssen Pharmaceutica N.V., Belgium, 4 mg/kg of body weight, i.m.) 15 min before the injection of the main anaesthetic, sodium thiopental (thiopental, Sandoz, Kundl-Rakusko, Austria; 10 mg/kg of body weight, i.v.). Following median laparotomy, the stomachs were exposed and injected with 50 μl (1 μl per 1 injection) of a 5% aqueous solution of the fluorescent retrograde neuronal tracer Fast Blue (FB, EMS-CHEMIE, GmbH, Germany) into the diamond-shaped part (ca. 4 cm × 4 cm) of the stomach anterior prepyloric walls.
Then, ASA pigs were given acetylsalicylic acid (aspirin, BAYER; 100 mg/kg b.w.) orally 1 h before feeding for 21 days (from 7th day after FB injection). On day 22 of the experiment, during laparotomy the partial resection of the previously FB-injected stomach prepyloric areas was performed with an electrosurgical diathermy (ERBE, VIO 300S) in animals of the RES group. On day 23, animals of the HCl group were reintroduced into a state of general anaesthesia (as described above) and intragastrically given 5 ml/kg of body weight of a 0.25 M aqueous solution of hydrochloric acid using a stomach tube. Gastroscopic examinations (using a video-endoscope Olympus GIF 145 with a working length of 1,030 mm and a 9.8 mm diameter) were performed in animals constituting ASA and HCL groups on the first day of the experiment and on the last day of the study. On day 28, all pigs were euthanized by an overdose of anaesthetic and then transcardially perfused with 4% buffered paraformaldehyde (pH 7.4). Following perfusion, the coeliac-superior mesenteric ganglion (CSMG) complexes were collected and postfixed by immersion in the same fixative for 20 minutes, rinsed in phosphate buffer (pH 7.4) for three days, and then stored in a 30% buffered sucrose solution until sectioning. Gastritis in animals of ASA group was confirmed by histopathological examination of fragments of the prepyloric stomach wall collected after perfusion (using routine histopathological methods).

To teach the exercise, we created the cord packing model fabrication video (Appendix A) along with the step-by-step instructional guide (Appendix B). The target audience for this activity was second-year preclinical dental students; the activity itself was an exercise in the simulation laboratory, course number 1636L. The students were just beginning the spring session and preparing for transition to clinic. They had previously received 2 hours of classroom presentations describing measures to facilitate tissue management and fluid control during impression procedures. The video reviewed tissue retraction techniques, when they should be used, and how those results would lead to an acceptable impression.
We created a 20-slide PowerPoint (Appendix E) to use at the commencement of the activity for review. The first portion of the presentation provided background information regarding the use of lasers, cord, and electrosurgery for GD. The second half reviewed cord placement technique. Faculty could determine the appropriate use of the PowerPoint presentation based on student need. We also created a short video of the students’ instructional guide (Appendix F) for faculty and/or student reference as needed. The implementation guide (Appendix G) provided overall guidance in facilitating the simulation exercise.
We asked instructors to distribute the instructional guide to the students and verbally review the goals for the exercise. The faculty-to-student ratio was 1:5. Instructors demonstrated the retraction cord placement technique to small groups. Following the demonstration, students received one-on-one opportunities to practice the technique for 10–15 minutes with verbal feedback from faculty. As this session was included as part of a larger daily simulation activity, no formal assessment was provided. The session was a completion exercise supported by verbal faculty feedback. We developed the cord packing assessment (Appendix H) to evaluate students’ skill at completion of the exercise.
To gain further understanding of the students’ experience, we expanded the activity to a convenience sample of third- and fourth-year students (n = 71) the following year. Verbal informed consent that described the purpose of participation was given by the students. The groups surveyed were D3s (formerly D2s) and D4s who had not previously experienced the exercise. The D4s (n = 34) were 3 months from completion of their clinical education. A survey for D3s (Appendix I) and a separate survey for D4s (Appendix J) were used to assess their perception of the exercise. This student cohort had the opportunity to review the instructional guide and practice on the cord placement technique model. The goal of involving the D4 students was to retrospectively determine if they felt it would have been helpful to have had the exercise during their preclinical education.