A diagnostic phase III/IV seamless design to investigate the diagnostic accuracy and clinical effectiveness using the example of HEDOS and HEDOS II.

The development process of medical devices can be streamlined by combining different study phases. Here, for a diagnostic medical device, we present the combination of confirmation of diagnostic accuracy (phase III) and evaluation of clinical effectiveness regarding patient-relevant endpoints (phase IV) using a seamless design. This approach is used in the Thyroid HEmorrhage DetectOr Study (HEDOS & HEDOS II) investigating a post-operative hemorrhage detector named ISAR-M THYRO® in patients after thyroid surgery. Data from the phase III trial are reused as external controls in the control group of the phase IV trial. An unblinded interim analysis is planned between the two study stages which includes a recalculation of the sample size for the phase IV part after completion of the first stage of the seamless design. The study concept presented here is the first seamless design proposed in the field of diagnostic studies. Hence, the aim of this work is to emphasize the statistical methodology as well as feasibility of the proposed design in relation to the planning and implementation of the seamless design. Seamless designs can accelerate the overall trial duration and increase its efficiency in terms of sample size and recruitment. However, careful planning addressing numerous methodological and procedural challenges is necessary for successful implementation as well as agreement with regulatory bodies.

Efficacy of four different hemostatic agents in thyroid surgery in reducing the amount of post-operative fluid collection.

PURPOSES: Postoperative bleeding remains a life-threatening complication in thyroid surgery. The aim was to assess the efficacy of four different hemostatic agents, Collagen-Fibrinogen-Thrombin Patch (CFTP) in two sizes (3 × 2.5 cm and 9.5 × 4.8 cm), polysaccharide particles (1 g) and Cellulose Gauze (2.5 × 5 cm) on postoperative drainage volume (DV) compared to a control group. METHODS: We included from October 2007 until Mai 2011, 150 patients (30 per group) for this monocentric, retrospective case-controlled study. Patients were scheduled for a hemithyroidectomy or thyroidectomy. The primary endpoint was the postoperative DV within the first 24 h, secondary the incidence of adverse events. RESULTS: There were no difference in demographic parameters. The mean DV (± SD) was 51.15 (± 36.86) ml in the control, 50.65 (± 42.79) ml in small (3 × 2.5 cm), 25.38 (± 23.99) ml in large CFTP (9.5 × 4.8 cm), 53.11 (± 39.48) ml in the polysaccharide particles and 48.94 (± 30.59) ml in the cellulose gauze group. DV was significantly reduced with the large CFTP (p < 0.05) compared to all other groups. There were no adverse events. CONCLUSIONS: We were able to demonstrate a significant reduction in the DV for the large CFTP group compared to the other collectives. Although this as being associated with not inconsiderable costs and we would only recommend its use for high-risk patients only.

Transoral thyroid surgery vestibular approach.

Objectives: Transoral thyroid surgery vestibular approach (TOETVA) is a novel and feasible surgical technique that allows for cervical surgery without visible incisions. TOETVA represents a new frontier in endocrine surgery since aesthetic results play a more and more decisive role in elective surgery. However, acceptance is different around the world with widespread prevalence in Asian countries and some high-volume centres in the US. While inclusion criteria for TOETVA are limited regarding size and volume a combination with other extracervical techniques like the retroauricular endoscopic cephalic access thyroid surgery (EndoCATS) approach or transaxillary access is an option. Methods: TOETVA is carried out through a three-port technique placed at the oral vestibule. Originally one 10-mm port for a 30° endoscope and two additional 5-mm ports for dissecting and coagulating instruments are used. Alternatively, one 5-mm and one or two 3 mm ports can be used. CO2 insufflation pressure is set at 6 mmHg. An additional device to optimize gas outflow for optimum view might be helpful. An anterior cervical subplatysmal space is created by hydrodissection from the oral vestibule to the sternal notch, laterally to the sternocleidomastoid muscle. Conventional endoscopic instruments are used. Combination of TOETVA with a modified retroauricular access includes insertion of a 10-12 mm trocar placed subcutaneously via a skin incision on the scalp, behind the ear by blunt dissection. Results: Since Anuwong published the first case series of 60 patients who underwent scarless thyroidectomy via the lower vestibule of the mouth with excellent results in 2016 almost 1,000 cases are reported in literature to date with comparable results especially regarding traditional complications. In contrast to other extracervical approaches, areolar or axillary for example, the transoral access route is short and the dissection planes are rather like transcervical surgery. Surgical indications and contraindications have been modified since its first description and are partly institution specific to date. To amend indications combination with other extracervical techniques is an option. In addition, patients must carefully be selected for and surgeons` candidacy is of utmost importance in transoral surgery. Conclusions: Transoral surgery will likely continue to gain attraction as surgeons become more experienced with the technique. With increased operative use and surgeon experience the gap in conventional outcomes between transoral surgery and the transcervical approach will narrow, with both operative time and the incidence of specific complications diminishing. Experience in thyroid and endoscopic surgery is required to achieve excellent results with low complication rates. However, the new transoral technique is related to novel complications that must be evaluated.

[Healthcare cost reimbursement without application-Experiences of a German bariatric service]. / Kostenübernahme bariatrischer Operationen ohne Antragstellung ­ Erfahrungen in einem deutschen Adipositaszentrum.

BACKGROUND: Only a small proportion of patients with morbid obesity in Germany have access to the currently most effective treatment, bariatric surgery. A major reason for this is the restrictive attitude of health insurance companies regarding the reimbursement of costs. OBJECTIVE: To record the postoperative rate of cost coverage by health insurance companies without the currently common preoperative application for morbidly obese patients who received a guideline-indicated bariatric surgery. METHODS: The process of postoperative reimbursement was evaluated through a prospective database over a 2-year period. Cases of primary reimbursement were correlated with respect to age, BMI, comorbidities and membership of a specific health insurance company. Rejected coverage cases were followed up for further advocacy and social court process. RESULTS: A total of 188 patients underwent bariatric surgery as indicated in the guidelines without prior application. Primary cost coverage was achieved in 76.6% (n = 144). There was no correlation with BMI, comorbidities or health insurance affiliation. Patients over 40 years of age were significantly more likely to be covered for costs. For patients without postoperative cost coverage, an out of court settlement was reached in 7 cases, 8 cases were heard by the social courts and 29 cases were still being processed by lawyers. CONCLUSION: Despite the relatively high rate of primary cost coverage, this analysis also shows the restrictive attitude of the health insurance companies regarding bariatric surgery with corresponding economic pressure on the service providers. The consistent implementation of application-free surgery seems necessary to increase the political pressure on health insurers and social courts.

Neck Circumference Measurement for Surveillance and Early Detection of Hemorrhage After Thyroidectomy: A Diagnostic Accuracy Study.

Importance: Postthyroidectomy hemorrhage is a potentially life-threatening complication with no reliable noninvasive method of early detection. Objective: To evaluate the diagnostic accuracy of neck circumference measurement for early detection of postoperative hemorrhage after thyroidectomy. Design, Setting, and Participants: This diagnostic accuracy study at an academic teaching hospital used a prospective cohort of patients undergoing thyroid surgery from November 1, 2015, to January 31, 2018 (group 1), and a retrospective cohort of patients undergoing the same surgery from January 1, 2020, to September 30, 2021 (group 2). We performed repeated perioperative neck circumference measurements to evaluate the association of increased neck circumference with postthyroidectomy hemorrhage among patients at risk for hemorrhage. Main Outcomes and Measures: The primary end point was the diagnostic value of neck circumference measurement for detection of postthyroidectomy hemorrhage. Additionally, data on demographic information and risk factors for postthyroidectomy hemorrhage were examined. Data analyses were performed from November 1, 2021, to January 5, 2022. Results: The prospective cohort (group 1) comprised 60 patients (45 [75%] women) with a mean (SD) age of 52.2 (13.5) years; those who experienced a postthyroidectomy hemorrhage had a mean (SD) age of 57.4 (9.0) years. The retrospective cohort (group 2) comprised 353 patients (258 [73%] women) with a mean (SD) age of 55.3 (14.1) years; patients who experienced a postthyroidectomy hemorrhage had a mean (SD) age of 62.2 (10.0) years. In group 1, postoperative neck circumference increased by a median (range) of 5.0 (4.0 to 7.0) cm in patients with hemorrhage, and only 1.0 (-2.5 to 4.0) cm in patients with no postoperative bleeding (difference in the medians, 4.0 cm [95% CI, 3.0 to 5.5 cm]; effect size, 3.74 [95% CI, 2.6 to 4.9]). Defining a 7% or greater increase in neck circumference as the cutoff value for detecting postthyroidectomy hemorrhage showed a diagnostic sensitivity and specificity of 1.0 (95% CI, 0.48 to 1.0) and 0.86 (95% CI, 0.71 to 0.92), respectively. The retrospective validation also showed a difference in median (range) increase of postoperative neck circumference between patients with hemorrhage and those without-3.0 (0 to 6.0) cm vs 0.0 (-6.0 to 5.0) cm (difference in medians, 3.8 cm [95% CI, 3.0 to 4.9]; effect size, 1.63 [95% CI, 0.96 to 2.3]). Considering 12 false-positive and 332 correct-negative results, the diagnostic tool showed a sensitivity of 0.89 (95% CI, 0.51 to 0.99) and a specificity of 0.97 (95% CI, 0.94 to 0.98). Conclusions and Relevance: The findings of this diagnostic accuracy study suggest that neck circumference measurement is a feasible and easy-to-use diagnostic tool for routine clinical care to detect postthyroidectomy hemorrhage. A 7% or greater increase over the postoperative baseline neck circumference seems to be a reliable threshold for detecting postthyroidectomy hemorrhage. Neck circumference measurement should be used in combination with surveillance of clinical signs and symptoms.

A cervical compartment syndrome impairs cerebral circulation in post-thyroidectomy hemorrhage: data from an animal model.

Background: Post thyroidectomy hemorrhage is a potentially life-threatening complication. As the mechanism leading to hypoxemic brain damage and death is still unknown, our aim was to examine the underlaying pathophysiology in an animal model. Methods: A series of experiments was performed in our established model for post thyroidectomy hemorrhage in 6 pigs. First, post thyroidectomy hemorrhage was simulated with an artificial increase of cervical compartment pressure. Second, spontaneous bleeding into the cervical compartment was initiated. Primary outcome measure is the correlation between cerebral oxygenation and cervical compartment pressure. Results: With an increase in cervical compartment pressure apnea could be detected in all experiments. A significant 24.2% (9.5-34.4%) decrease of cerebral oxygenation at time of apnea (47.0%; 38.0-65.0%) compared to baseline values (63.5%; 56.0-74.0%; P=0.043) occurred due increase of cervical compartment pressure concurrent with an impaired cerebral perfusion. Apnea occurred about 200 sec after a 10% decrease of cerebral oxygenation, but 35 sec before a 10% decrease of peripheral oxygenation. Spontaneous bleeding into the cervical compartment causes an increase of cervical compartment pressure reaching levels of the mean arterial blood pressure 56.0 (35.0-72.0) mmHg. Conclusions: Peripheral hypoxemia occurs with relevant delay in time after decrease of cerebral perfusion and cerebral hypoxemia, therefore cerebral hypoxemia seems to be causal for a central apnea. With this evidence of impaired cerebral perfusion and cerebral hypoxemia due to an increased cervical compartment pressure we can disprove the historic theory of tracheal collapse due to a compressive hematoma in post thyroidectomy hemorrhage. A cervical compartment syndrome seems to be causal, not only for brain hypoxemia but also an additional laryngo-pharyngeal mucosal edema.

Transoral thyroid surgery vestibular approach: is there an increased risk of surgical site infections?

Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is an upcoming surgical technique with the aim to optimize cosmetic outcome avoiding visible scars in the neck. However, the transoral access bears the risk of contamination and microbial allocation from the mouth into the thyroid region. Therefore, some authors recommend extended antibiotic therapy up to 7 days after surgery. Our aim was to evaluate infection rates and parameters before and after transoral surgery and to suggest a viable and safe routine in transoral surgery. Prospectively collected data of patients who were eligible for transoral surgery in Austria and Germany between June 2017 and July 2020 were retrospectively evaluated focussing on clinical and laboratory infection signs pre and postoperatively. White blood cell count (WBC) and C-reactive protein levels (CRP) were estimated before and after surgery. Patients` characteristics, surgical outcome and complications were also determined and compared to the current results reported in the literature. 113 transoral operations were performed in 108 patients. In 37 of 108 (36%) patients an additional retroauricular incision in the hairline and in two patients a submental skin incision was performed to extract thyroid specimen of more than 40 ml. Intravenous antibiotic prophylaxis and enoral mucosal disinfection were used in all patients before surgery. WBC and CRP levels were available in 75 patients. Median WBC was 5800/µl (range 3500-10,500/µl) before and significantly higher (median 8900/µl, range 4500-18,800 µl; p < 0.01) at day one after surgery. WBC returned to normal range (4500-11,500/µl) in all patients within the first 7 days postoperatively (median 5300/µl, range 3400-8700/µl). CRP levels were normal before (< 0.5 mg/dl) and slightly elevated within the first two days after surgery (Median 2.0 mg/dl, range 0.5-6.4 mg/dl, n.s.). In one patient oral antibiotic therapy was necessary due to transient erythema in the chin region which occurred 10 days after surgery and resolved completely without surgical intervention. Despite a transient increase in WBC transoral thyroid and parathyroid surgery via the vestibular approach does not seem to be associated with a significant number of wound infections in our patients. Intravenous antibiotic prophylaxis and enoral mucosal disinfection might be reasonable procedures to avoid microbial allocation from the mouth into the thyroid region. However, further investigations are required to finally estimate the need of antibiotics in transoral surgery.

Endoscopic cephalic access thyroid surgery (EndoCATS) using the retroauricular approach - a single centre retrospective data analysis.

BACKGROUND: Due to improvements in endoscopic as well as robotic technology, and a request for better cosmetic results, there was a significant increase in thyroid surgery using these methods during the past decade. METHODS: The aim of our study is to evaluate the perioperative short- and long-term outcome as well as the learning curve of EndoCATS and the Quality of Life (QoL). RESULTS: A total of 150 patients with 152 hemithyroidectomies who underwent endoscopic thyroid surgery by EndoCATS between 2010 and 2016 were enrolled in this study. The mean specimen volume was 15.04 g ± 7.89 g. The mean operation time was 132.79 ± 50.52 min. There is a significant reduction of the operation time after the 53th case. (p < 0.05) There was no acute rebleeding or permanent hypoparathyroidism. Permanent RLN palsy occurred in 3 nerves at risk (NAR) 1.97%. There were no cases of pneumothorax, postoperative infections or skin flap ischemia. 94.11% of the patients describe their state of general health as good as or better than before the surgery. CONCLUSIONS: EndoCATS is a safe and effective, but a demanding single port access procedure; therefore, extensive training is required. An advantage is the near ideal visualization of the RLN and the parathyroid glands as well as the ability to recover even large specimens without difficulties.

Quality of life and surgical outcome of ABBA versus EndoCATS endoscopic thyroid surgery: a single center experience.

BACKGROUND: Thyroid surgery is often performed, especially in young female patients. As patient satisfaction become more and more important, different extra-cervical "remote" approaches have evolved to avoid visible scars in the neck for better cosmetic outcome. The most common remote approaches are the transaxillary and retroauricular. Aim of this work is to compare Endoscopic Cephalic Access Thyroid Surgery (EndoCATS) and axillo-bilateral-breast approach (ABBA) to standard open procedures regarding perioperative outcome and in addition to control cohorts regarding quality of life (QoL) and patient satisfaction. METHODS: In a single center, 59 EndoCATS und 52 ABBA procedures were included out of a 2 years period and compared to 225 open procedures using propensity-score matching. For the endoscopic procedures, cosmetic outcome, patient satisfaction and QoL (SF-12 questionnaire) were examined in prospective follow-up. For QoL a German standard cohort and non-surgically patients with thyroid disease were used as controls. RESULT: The overall perioperative outcome was similar for all endoscopic compared to open thyroid surgeries. Surgical time was longer for endoscopic procedures. There were no cases of permanent hypoparathyroidism and no significant differences regarding temporary or permanent recurrent laryngeal nerve (RLN) palsies between open and ABBA or EndoCATS procedures (χ2; p = 0.893 and 0.840). For ABBA and EndoCATS, 89.6% and 94.2% of patients were satisfied with the surgical procedure. Regarding QoL, there was an overall significant difference in distribution for physical, but not for mental health between groups (p < 0.001 and 0.658). Both endoscopic groups performed slightly worse regarding physical health, but without significant difference between the individual groups in post hoc multiple comparison. CONCLUSION: Endoscopic thyroid surgery is safe with comparable perioperative outcome in experienced high-volume centers. Patient satisfaction and cosmetic results are excellent; QoL is impaired in surgical patients, as they perform slightly worse compared to German standard cohort and non-surgical patients.

Long-term outcome and chronic pain in atraumatic fibrin glue versus staple fixation of extra light titanized meshes in laparoscopic inguinal hernia repair (TAPP): a single-center experience.

BACKGROUND: Inguinal hernia repair belongs to the most frequently performed surgical procedures. Endoscopic techniques like TAPP and TEP have become standard of care together with the conventional open techniques. Especially in endoscopic techniques, there is a confusing amount of different meshes and fixation techniques with impact on perioperative and long-term outcome. We present the first single-center data on the use of titanized extra lightweight meshes and fibrin glue fixation compared to staple fixation regarding long-term outcome, especially chronic pain. MATERIALS AND METHODS: A clinical trial with retrospective analysis of patient- and procedure-related data and questionnaire-based follow-up of TAPP procedures performed in 2012-2014 was conducted in a specialized hernia center. Standard TAPP technique was used with placement of TiMesh extra light (16 g/m2) and either fibrin glue or staple fixation. Procedure- and patient-related data are compared after propensity score matching regarding perioperative complications and long-term outcome. RESULTS: Of 612 TAPP procedures 372 procedures were included in analysis after propensity score matching. Fibrin glue was used in n = 279 and staple fixation in n = 93 cases. There were significant differences regarding duration of the surgical procedures (p = 0.001) and distribution of mesh size. No differences were noted regarding perioperative complications such as seroma or hematoma formation and need for re-laparoscopy. During a mean follow-up of 32.1 ± 20.6 month with a follow-up rate of 79%, there was no difference in long-term outcome, especially for rate of recurrence (p = 0.112) and development of chronic pain (p = 0.846). The overall rate of recurrence was 3.0% (n = 11), and in 2.4% (n = 9) patients complained of chronic pain. CONCLUSION: Inguinal hernia repair using extra lightweight titanized meshes and fibrin glue fixation is safe and feasible compared to staple fixation even in large and combined hernia defects, if mesh size is adjusted to size of hernia defect. The rate of chronic pain was extremely low at 2.4%.

New insights into the pathophysiology of postoperative hemorrhage in thyroid surgery: An experimental study in a porcine model.

BACKGROUND: Postoperative cervical hemorrhage is a rare but life-threatening complication that can cause severe morbidity. Different mechanisms leading to asphyxia have been described based only on clinical observation. METHODS: We performed a series of in vivo animal studies simulating post-thyroidectomy hemorrhage and its effect on respiratory drive. Three series of tests were carried out in 12 German domestic pigs under general anesthesia. The pigs were breathing spontaneously with secured airways. An additional series using functional magnetic resonance imaging of the pigs' brainstem was also conducted. RESULTS: The first experimental series carried out on 2 animals revealed an obvious difference between the effects of cervical hemorrhage and external bleeding with development of hemorrhagic shock. An experimental setting for the repeated simulation of cervical hemorrhage was established. A pressure-dependent mechanism was discovered that led to apnea in every animal despite the secured airway. In 8 of 10 animals, relief of cervical pressure led to complete respiratory recovery. The test was repeated up to 6 times per pig. Apnea was induced in 25 of 25 test procedures (100%) and was followed by respiratory recovery in 22 of 25 tests (88%). The threshold pressure at which the respiratory rate started to decrease was 47 ± 14 Torr when blood was used to increase the cervical compartment pressure. When silicone oil was used in a further experimental series, the threshold pressure was similar at 44 ± 21 Torr. The cervical compartment pressure needed to induce apnea was 74 ± 18 Torr using blood and 74 ± 39 Torr using silicone oil, both of which exceeded the mean arterial pressure by 28 Torr during apnea. Functional magnetic resonance imaging revealed a decrease in brainstem activity during phases of increased cervical compartment pressure, which suggests a possible role for cerebral vascular perfusion. CONCLUSION: Respiratory drive can be suppressed by increased pressure in the cervical compartment, possibly because of a pressure-dependent impairment in cerebral perfusion through a form of cervical compartment phenomenon or, less likely, a pressure-dependent reflex (nervous) mechanism.

Local antibiotic decontamination to prevent anastomotic leakage short-term outcome in rectal cancer surgery.

PURPOSE: Anastomotic leakage still presents an issue in rectal cancer surgery with rates of about 11%. As bacteria play a critical role, there is the concept of perioperative local decontamination to prevent anastomotic leakage. METHODS: To ascertain the effectiveness of this treatment, we performed a retrospective analysis on 206 rectal resections with primary anastomosis and routine use of a selective decontamination of the digestive tract (SDD) regimen for local decontamination. SDD medication was administered every 8 h from the day before surgery to the seventh postoperative day. All patients were treated according to the fast-track protocol without mechanical bowel preparation; instead, a laxative was used. RESULTS: Overall morbidity was 30%, overall mortality 0.5%. In our data, overall rate of anastomotic leakage (AL) was 5.8%, with 3.9% in anterior rectal resection and 6.5% in low anterior rectal resection group. In 75% of cases, anastomotic leakage was grade "C" and needed re-laparotomy. Surgical site infection rate was 19.9%. No serious adverse events were related to decontamination. CONCLUSION: Local antibiotic decontamination appears to be safe and effective to decrease the rate of anastomotic leakage in rectal cancer surgery. Further focus should be on perioperative management including bowel preparation and choice of antimicrobial agents for local decontamination.

Compartment Pressure Monitoring After Thyroid Surgery: A Possible Method to Detect a Rebleeding.

BACKGROUND: Postoperative rebleeding after thyroid surgery is a rare but a serious complication. The aim of this study was to ascertain the extent to which postoperative pressure could be used as detector for rebleeding after thyroid surgery. METHODS: Thirty-two patients with thyroidectomy or hemithyroidectomy were considered prospectively. In the course of surgery, a pressure microsensor (3PN Probe Spiegelberg) was implanted into the postoperative cavity and data were collected for special activities and stress situations over the first 48 h postoperatively. Additional endpoint was the influence of drains on the determined values. RESULTS: The overall mean pressure (MP) at rest on both postoperative days for all patients with and without drain was 0.36 ± 2.84 mmHg (range -6.7 to 6.7). The MP in all activity and stress situations on the first day was with 0.23 ± 3.71 mmHg, and on the second day, the MP was 1.33 ± 4.50. 92.13% of our values were below 7 mmHg. One patient had a hemorrhage. The pressure increases continuously up to 36 mmHg, before the patient was transferred to the operating theater. CONCLUSIONS: This is the first pilot study to consider continuous pressure measurement to be a potential tool for early detection of a postoperative rebleeding in thyroid surgery. In the strictest sense, postoperative intra-cervical pressure at rest ranges from subatmospheric to 7 mmHg. The elevation of pressure in case of a rebleeding up to 36 mmHg differs dramatically from normal postoperative pressure. The collected data will warrant further validation to be able to recommend threshold values for an early treatment decisions in rebleeding.

[Traumatic thyroid rupture: case report and review of the literature]. / Traumatische Schilddrüsenruptur: Fallbericht und Literaturübersicht.

BACKGROUND: Traumatic rupture of the thyroid gland is rare. A common approach does not exist. Surgical and nonsurgical management have been advocated. METHOD: This work summarizes the publications in PubMed including an own case. This study will analyse the accident mechanism, the underlying thyroid pathologies, possible pathogenetic mechanisms of airway obstruction and the therapeutic options. A present classification is revised in order to develop it into a treatment proposal. RESULTS: A total of 34 case reports were analysed. The first half had to be performed a surgery on, the other half was observed without surgical treatment. None of the patients died of his injury. 59% of the patients, that had to be performed a surgery on had thyroid pathology before rupture. 50% of all patients had a road accident as a cause for the rupture. CONCLUSION: The revised classification and treatment proposal developed here presents a clinically-viable approach.

Invisible scar endoscopic thyroid surgery by the dorsal approach: importance of the spinal accessory nerve.

PURPOSE: With about 100,000 surgeries per year in Germany, thyroid operations count among the most common procedures performed in general and endocrine visceral surgery. Twentieth century technological development gives the opportunity to perform thyroid surgery without leaving visible scar like conventional approaches do. This study is part of the work on the videoendoscopic retro-auricular access to the thyroid gland using the EndoCATS method by Schardey and Schopf. To avoid possible complications with the spinal accessory nerve (SAN), like irritation or injury of the nerve as happened during a feasibility study, a systematic study of the surgical anatomy at the nerve's entry to the posterior cervical triangle is performed especially in relation to the EndoCATS operation method. METHODS: Sixty-one neck regions in fifty-three specimens were examined at the anatomical institute of Munich to investigate the course of the SAN relative to the anatomic landmarks tip of mastoid bone, sternal notch, and posterior border of the sternocleidomastoid muscle together with the SAN's course variants at its entry to the posterior cervical triangle. The results were then statistically analyzed. RESULTS: From this analysis, we derived a simple method to predict the course of the SAN preoperatively and offer a new approach to protect the SAN during EndoCATS surgery. Additionally, we found a significant difference of the SAN's course between male and female specimens. CONCLUSION: The EndoCATS method can be a safe alternative to conventional thyroid surgery, but the SAN is at risk during the surgery procedure. Here we give feasible solutions to eliminate the SAN-problem performing EndoCATS thyroid surgery.

Chronic pain after laparoscopic transabdominal preperitoneal hernia repair: a randomized comparison of light and extralight titanized polypropylene mesh.

BACKGROUND: The aim of this prospective, randomized, single-blinded clinical trial was to compare the incidence of chronic pain after laparoscopic transabdominal preperitoneal hernia repair (TAPP) using a 35-g/m2 titanized polypropylene mesh and a 16-g/m2 titanized polypropylene mesh. The reported incidence of chronic pain in patients who underwent laparoscopic hernia repair is a serious problem. The techniques of dissection, mesh fixation, and the mesh material used have all been identified as being part of the problem. Excellent biocompatibility through a unique combination of a lightweight open porous polypropylene mesh covered with a covalent-bonded titanium layer has been claimed. The aim of this study was to find out whether the titanium surface alone or the difference in material load between the two available meshes influences clinical outcomes. METHODS: Three hundred eighty patients with 466 inguinal hernias were operated on between 2002 and 2006 with the laparoscopic transabdominal preperitoneal (TAPP) technique. Mesh fixation with staples was carried out routinely. After the dissection was completed just prior to the implantation of the mesh, patients were randomized into two groups. In Group A, 250 (53.6%) inguinal hernias were repaired with a 35-g/m2 titanized polypropylene mesh, and in Group B, 216 (46.4%) inguinal hernias were repaired with a 16-g/m2 titanized polypropylene mesh. The primary outcome was chronic pain 3 years after surgery. The degree of pain was determined using a visual analog scale (VAS) with a range from 0 to 10. The secondary outcome was the rate of recurrence. RESULTS: The postoperative period of observation was at least 3 years for every patient. In both groups, 90% of the patients could be questioned and examined clinically: in Group A (Light), 5.3% of the patients and in Group B (Extralight), 1.5% of the patients suffered from chronic pain. Chronic pain was significantly more common in Group A than in Group B (p=0.037). There was no difference with respect to the rate of recurrence: for Group A it was 3.1% and for Group B it was 2.6% (p=0.724). CONCLUSIONS: Chronic pain is not very common in patients who have had their inguinal hernias repaired with titanium-covered polypropylene mesh. Reducing the material load from 35 to 16 g/m2 seems to further improve the biocompatibility of these meshes, thus improving the clinical outcome by reducing chronic pain to a rare event. The role of staples in causing chronic pain following inguinal hernia repair may be overestimated. There was no evidence supporting the notion that the use of the 16-g/m2 titanized meshes is associated with increased recurrence rates.