Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study.

BACKGROUND: Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study aimed to evaluate the safety and effectiveness of the novel thermoSEAL electrosurgical vessel sealing mode (TSM). The BiClamp® mode (BCM) of the renowned VIO® 300 D ESU served as control. BCM has been widely available since 2002 and has since been successfully used in many surgical disciplines. The TSM, for the novel VIO® 3 ESU, was developed to reduce sealing time and/or thermal lateral spread adjacent to the seal while maintaining clinical success rates. The primary aim of this study was to investigate the long-term and intraoperative seal quality of TSM. METHODS: The BiCision® device was used for vessel sealing with TSM and BCM in ten German Landrace pigs which underwent splenectomy and unilateral nephrectomy during the first intervention of the study. The seals were cut with the BiCision® knife. Ninety-nine arteries, veins and vascular bundles were chronically sealed for 5 or 21 days. Thereafter, during the second and terminal intervention of the study, 97 additional arteries and veins were sealed. The carotid arteries were used for histological evaluation of thermal spread. RESULTS: After each survival period, no long-term complications occurred with either mode. The intraoperative seal failure rates, i.e. vessel leaking or residual blood flow after the first sealing activation, were 2% with TSM versus 6% with BCM (p = 0.28). The sealing time was significantly shorter with TSM (3.5 ± 0.69 s vs. 7.3 ± 1.3 s, p < 0.0001). The thermal spread and burst pressure of arteries sealed with both modes were similar (p = 0.18 and p = 0.61) and corresponded to the histological evaluation. The measured tissue sticking parameter was rare with both modes (p = 0.33). Tissue charring did not occur. Regarding the cut quality, 97% of the seals were severed in the first and 3% in the second attempt (both with TSM and BCM). CONCLUSIONS: The novel TSM seals blood vessels twice as fast as the BCM while maintaining excellent tissue effect and clinical success rates. TRIAL REGISTRATION: Not applicable.

A prospective randomized experimental study to investigate the peritoneal adhesion formation after waterjet injection and argon plasma coagulation (HybridAPC) in a rat model.

BACKGROUND: This prospective, randomized, controlled, single-blinded study investigates the peritoneal adhesion formation of HybridAPC (waterjet elevation of the peritoneum with subsequent argon plasma coagulation) versus only waterjet (elevation with the same instrument, but without subsequent argon plasma coagulation) in a rat model (24 female Wistar rats). MATERIALS AND METHODS: Bilateral lesions were created on the abdominal wall with HybridAPC on one sidewall and waterjet elevation on the other sidewall of the peritoneum in a standard fashion. After 10 days, the rats were euthanized to evaluate the peritoneal trauma sites. MAIN OUTCOME MEASURE(S): Adhesion incidence, quantity, and quality were scored 10 days postoperatively and studied histopathologically. RESULT(S): Incidence of adhesion formation was 2.3% for HybridAPC; no adhesions occurred for peritoneal elevation with saline (p = 1.00). Histologic evaluation revealed no acute inflammation in both groups. An overall moderate degree of granulation tissue formation and myonecrosis was observed in the HybridAPC group, whereas no chronic inflammation and myonecrosis occurred after elevation without thermal ablation (p < 0.0001). CONCLUSION(S): This study investigates the effect of waterjet elevation of the peritoneum with and without subsequent thermal ablation on adhesion formation in a rat model for the first time. Peritoneal waterjet elevation with saline does not provide any risk of adhesion formation. Thermal coagulation with APC after waterjet elevation of the peritoneum creates advantageous peritoneal conditions due to a permanent moist tissue surface and the cooling effect of the injected solution, resulting in no significant difference in adhesion formation compared to peritoneal elevation without thermal ablation. HybridAPC can thus be regarded as a beneficial coagulation method with only minor adhesion formation due to positive tissue effects of the combined waterjet.

A Prospective Randomized Experimental Study to Investigate the Eradication Rate of Endometriosis after Surgical Resection versus Aerosol Plasma Coagulation in a Rat Model.

PURPOSE: To investigate the eradication rate of endometriosis after surgical resection (SR) vs. thermal ablation with aerosol plasma coagulation (AePC) in a rat model. METHODS: In this prospective, randomized, controlled, single-blinded animal study endometriosis was induced on the abdominal wall of 34 female Wistar rats. After 14 days endometriosis was either removed by SR or ablated by AePC. 14 days later the rats were euthanized to evaluate the eradication rate histopathologically. Intervention times were recorded. RESULTS: Eradication rate of endometriosis after 14 days did not significantly differ between AePC and SR (p=0.22). Intervention time per endometrial lesion was 22.1 s for AePC and 51.8 s for SR (p<0.0001). CONCLUSIONS: This study compares the eradication rate of the new aerosol plasma coagulation device versus standard surgical resection of endometriosis in a rat model. Despite being a thermal method, AePC showed equality towards SR regarding eradication rate but with significantly shorter intervention time.

Large Conization-Retrospective Monocentric Results for Fertility Preservation in Young Women with Early Stage Cervical Cancer.

The shorter cervical segment after classic radical trachelectomy (RT) imposes a number of pregnancy associated risk factors. In this aspect, large conization (LC) could be an oncologically safe alternative to RT in young women with early stage cervical cancer who want to spare their fertility. Our aim was to evaluate fertility-sparing surgical treatment of early stage cervical cancer after the introduction of LC. Our objectives were to assess surgical, oncological, fertility and obstetric outcomes. We retrospectively investigated oncological and fertility outcomes of patients who underwent LC in a large oncological single University centre between 2009 and 2014. Medical records were reviewed and analysed for surgical, oncological, fertility and obstetric outcomes. Postal questionnaires were collected to further evaluate and validate the fertility and obstetric outcomes. A total of 23 LCs were analysed. Seven patients had to undergo secondary radical hysterectomy after LC due to unclear resection margins. Nine of 16 women tried to conceive, of which all nine became pregnant. Seven patients underwent a prophylactic cerclage between 13 and 16 gestational weeks and seven women delivered 9 children; the majority of women conceived spontaneously. Follow-up time was a median of 3.9 years (2.6-8 years). There was no relapse of cervical cancer in the investigated timeframe. Early stage cervical cancers treated by LC are associated with excellent oncological outcomes. LC appears to be a safe option for eligible women who intend to maintain their fertility.

Randomized experimental study to investigate the peritoneal adhesion formation of conventional monopolar contact coagulation versus noncontact argon plasma coagulation in a rat model.

OBJECTIVE: To investigate peritoneal adhesion formation of monopolar contact coagulation (MCC) versus noncontact argon plasma coagulation (APC) in a rat model. DESIGN: Randomized, controlled, single-blinded animal study. SETTING: University laboratory. ANIMAL(S): Sixteen female Wistar rats. INTERVENTION(S): Bilateral lesions were created on the abdominal wall with MCC and APC in a standard fashion. After 10 days, the rats were euthanized to evaluate the peritoneal trauma sites. MAIN OUTCOME MEASURE(S): Adhesion incidence, quantity, and quality were scored 10 days postoperatively and studied histopathologically. RESULT(S): Average energy intake was 99.5 ± 7.39 J for APC and 95.7 ± 9.62 J for monopolar contact coagulation. Incidence of adhesion formation was 50.0% for noncontact APC and 85.4% for MCC. MCC induced significantly more vascular adhesions. Histological evaluation revealed no significant differences regarding average depth of lesions induced by APC and MCC. Both groups showed almost identical morphology of necrosis and granulation tissue formation. CONCLUSION(S): This study compares for the first time adhesion formation of MCC versus noncontact APC in a rat model. With a similar energy intake, contact coagulation induced a significantly higher rate of adhesion formation. APC-induced adhesions were significantly less vascularized compared with MCC adhesions. Besides the thermal effects of both coagulation methods, the direct mechanical contact of the MCC electrode with the highly sensitive peritoneum is thus determined to be a pivotal additional stimulus for adhesion formation.

[Vaginal bleeding as symptom of a medical emergency--pitfalls of therapy with new oral anticoagulants - case 5/2014]. / Vaginale Blutung als Symptom eines internistischen Notfalls--Tücken der Therapie mit neuen oralen Antikoagulanzien - Fall 5/2014.

HISTORY AND ADMISSION FINDINGS: A 90-year-old female patient treated with dabigatran for atrial fibrillation presented emergently with a spontaneous vaginal bleeding due to endometrium carcinoma. INVESTIGATIONS: Laboratory analysis revealed azotemia consistent with acute-on-chronic renal failure. Coagulation was deranged (prolongation of activated partial thromboplastin time (aPTT) by 3.5-fold, international normalized ratio (INR) 7.8) due to a massive accumulation of dabigatran (measured plasma concentration 2230 ng/ml). DIAGNOSIS, TREATMENT AND COURSE: Vaginal bleedings were treated with external tamponade. Hemodialysis treatment was commenced due to uremia and dabigatran accumulation. Over night, the patient was dialysed with a SLED (sustained low efficiency dialysis) regimen. After volume resuscitation renal function promptly ensued indicating prerenal azotemia as a cause of renal failure. After two more hemodialysis sessions dabigatran concentrations were no longer detecable and this was paralleled by normalization of coagulation tests. CONCLUSIONS: Dabigatran can accumulate massively during acute renal failure and evoke a life-threatening bleeding diathesis. Dabigatran can be removed with low efficient dialysis (such as SLED).