A flexible implant for acute intrapancreatic electrophysiology.

Microelectrode arrays (MEAs) have proven to be a powerful tool to study electrophysiological processes over the last decades with most technology developed for investigation of the heart or brain. Other targets in the field of bioelectronic medicine are the peripheral nervous system and its innervation of various organs. Beyond the heart and nervous systems, the beta cells of the pancreatic islets of Langerhans generate action potentials during the production of insulin. In vitro experiments have demonstrated that their activity is a biomarker for blood glucose levels, suggesting that recording their activity in vivo could support patients suffering from diabetes mellitus with long-term automated read-out of blood glucose concentrations. Here, we present a flexible polymer-based implant having 64 low impedance microelectrodes designed to be implanted to a depth of 10 mm into the pancreas. As a first step, the implant will be used in acute experiments in pigs to explore the electrophysiological processes of the pancreas in vivo. Beyond use in the pancreas, our flexible implant and simple implantation method may also be used in other organs such as the brain.

Impact of preoperative body mass index and weight loss on morbidity and mortality following colorectal cancer-a retrospective cohort study.

PURPOSE: Body weight and preoperative weight loss (WL) are controversially discussed as risk factors for postoperative morbidity and mortality in colorectal cancer surgery. The objective of this study is to determine whether body mass index (BMI) or WL is associated with a higher postoperative complication rate. METHODS: In this retrospective cohort study, data analysis of 1241 consecutive patients undergoing colorectal cancer surgery in an 11-year period was performed. The main outcome measures were wound infections (WI), anastomotic leakages (AL), and in-house mortality. RESULTS: A total of 697 (56%) patients with colon and 544 (44%) with rectum carcinoma underwent surgery. The rate of WI for each location increased with rising BMI. The threshold value was 28.8 kg/m2. Obese patients developed significantly more WI than normal-weight patients did following rectal resection (18.0% vs. 8.2%, p = 0.018). Patients with preoperative WL developed significantly more AL following colon resections than did patients without preoperative WL (6.2% vs. 2.5%, p = 0.046). In-house mortality was significantly higher in obese patients following colon resections than in overweight patients (4.3% vs. 0.4%, p = 0.012). Regression analysis with reference to postoperative in-house mortality revealed neither increased BMI nor WL as an independent risk factor. CONCLUSIONS: Increased preoperative BMI is associated with a higher WI rate. AL rate after colon resection was significantly higher in patients showing preoperative WL. Preoperative BMI and WL are therefore risk factors for postoperative morbidity in this study. Nevertheless, this has to be further clarified by means of prospective studies. Trial registration DRKS00025359, 21.05.2021, retrospectively registered.

Early postoperative endoscopic evaluation of rectal anastomoses: a prospective cross-sectional study.

BACKGROUND: Reported incidence of anastomotic leakage (AL) of rectal anastomoses is up to 29% with an overall mortality up to 12%. Nevertheless, there is no uniform evidence-based diagnostic procedure for early detection of AL. The objective of this prospective clinical trial was to demonstrate the diagnostic value of early postoperative flexible endoscopy for rectal anastomosis evaluation. METHODS: Flexible endoscopy between 5 and 8th postoperative day was performed consecutively in 90 asymptomatic patients. Sample size calculation was made using the two-stage Simon design. Diagnostic value was measured by management change after endoscopic evaluation. Anastomoses were categorized according to a new classification. Study is registered in German Clinical Trials Register (DRKS00019217). RESULTS: Of the 90 anastomoses, 59 (65.6%) were unsuspicious. 20 (22.2%) were suspicious with partial fibrin plaques (n = 15), intramural hematoma and/or local blood coagulum (n = 4) and ischemic area in one. 17 of these anastomoses were treated conservatively under monitoring. In three a further endoscopic re-evaluation was performed and as consequence one patient underwent endoscopic vacuum therapy. 11 (12.2%) AL were detected. Here, two could be treated conservatively under monitoring, four with endoscopic vacuum therapy and five needed revision surgery. No intervention-related adverse events occurred. A change in postoperative management was made in 31 (34.4%) patients what caused a significant improvement of diagnosis of AL (p < 0.001). CONCLUSIONS: Early postoperative endoscopic evaluation of rectal anastomoses is a safe procedure thus allows early detection of AL. Early treatment for suspicious anastomoses or AL could be adapted to avoid severe morbidity and mortality.

[Laparoscopic Heller Myotomy in the Treatment of Achalasia]. / Laparoskopische Heller-Myotomie zur Therapie der Achalasie.

BACKGROUND: Achalasia refers to a primary oesophageal motility disorder characterised by the absence of peristalsis and incomplete or complete lack of relaxation of the lower oesophageal sphincter. The cardinal symptom is dysphagia. The therapeutic goal is surgical or interventional repair of the oesophageal outflow tract at the level of the oesophagogastric junction. INDICATION: We present the case of a 24-year-old patient with dysphagia accompanied by regurgitations, odynophagia as well as an unintentional weight loss over two years. METHODS: The video describes the preoperative imaging as well as endoscopic findings and demonstrates the technique of laparoscopic Heller myotomy followed by Dor fundoplication. CONCLUSIONS: Concerning the therapy of classic achalasia, laparoscopic Heller myotomy followed by Dor fundoplication - despite controversies regarding peroral endoscopic myotomy as an alternative therapeutic option - can be considered as an established standard procedure.

Learning curves, potential and speed in training of laparoscopic skills: a randomised comparative study in a box trainer.

BACKGROUND: The effectiveness of practical surgical training is characterised by an inherent learning curve. Decisive are individual initial starting capabilities, learning speed, ideal learning plateaus, and resulting learning potentials. The quantification of learning curves requires reproducible tasks with varied levels of difficulty. The hypothesis of this study is that the use of three-dimensional (3D) vision is more advantageous than two-dimensional vision (2D) for the learning curve in laparoscopic training. METHODS: Forty laparoscopy novices were recruited and randomised to a 2D Group and a 3D Group. A laparoscopy box trainer with two standardised tasks was used for training of surgical tasks. Task 1 was a positioning task, while Task 2 called for laparoscopic knotting as a more complex process. Each task was repeated at least ten times. Performance time and the number of predefined errors were recorded. 2D performance after 3D training was assessed in an additional final 2D cycle undertaken by the 3D Group. RESULTS: The calculated learning plateaus of both performance times and errors were lower for 3D. Independent of the vision mode the learning curves were smoother (exponential decay) and efficiency was learned faster than precision. The learning potentials varied widely depending on the corresponding initial values and learning plateaus. The final 2D performance time of the 3D-trained group was not significantly better than that of the 2D Group. The final 2D error numbers were similar for all groups. CONCLUSIONS: Stereoscopic vision can speed up laparoscopic training. The 3D learning curves resulted in better precision and efficiency. The 3D-trained group did not show inferior performance in the final 2D cycle. Consequently, we encourage the training of surgical competences like suturing and knotting under 3D vision, even if it is not available in clinical routine.

Impact of haptic feedback on applied intracorporeal forces using a novel surgical robotic system-a randomized cross-over study with novices in an experimental setup.

BACKGROUND: Most currently used surgical robots have no force feedback; the next generation displays forces visually. A novel single-port robotic surgical system called FLEXMIN has been developed. Through an outer diameter of 38 mm, two instruments are teleoperated from a surgeon's control console including true haptic force feedback. One additional channel incorporates a telescope, another is free for special instrument functions. METHODS: This randomized cross-over study analyzed the effect of haptic feedback on the application of intracorporeal forces. In a standardized experiment setup, the subjects had to draw circles with the surgical robot as gently as possible. The applied forces, the required time spans, and predefined error rates were measured. RESULTS: Without haptic feedback, the maximum forces (median/IQR) were 6.43 N/2.96 N. With haptic feedback, the maximum forces were lower (3.57 N/1.94 N, p < 0.001). Also, the arithmetic means of the force progression (p < 0.001) and their standard deviations (p < 0.001) were lower. Not significant were the shorter durations and lower error rates. No sequence effect of force or duration was detected. No characteristic learning or fatigue curve was observed. CONCLUSIONS: In the experiment setup, the true haptic force feedback can reduce the applied intracorporeal robotic force to one-half when considering the aspects maximum, means, and standard deviation. Other test tasks are needed to validate the influence of force feedback on surgical efficiency and safety.

[Robotic Assisted Proctocolectomy with Ileal Pouch-Anal Anastomosis in a Case of Suspected Hereditary Polyposis]. / Roboterassistierte Proktokolektomie mit ileopouchanaler Anastomose bei Verdacht auf hereditäre Polyposis.

BACKGROUND: Various forms of hereditary polyposis have been described in the literature. Classical familial adenomatous polyposis (FAP) is a rare, autosomal dominantly inherited disease which is caused by a germline mutation in the adenomatous polyposis coli gene (APC). Patients with this diagnosis successively develop multiple polyps of the colon. Left untreated, FAP almost inevitably leads to malignant transformation. INDICATION: We present the case of a 37-year-old patient with histologically confirmed, stenotic adenocarcinoma of the descending colon and an initially suspected hereditary polyposis due to multiple polyps in the descending and sigmoid colon. METHODS: The video describes the preoperative imaging as well as endoscopic findings and demonstrates the technique of a two-stage, robotically assisted proctocolectomy with ileal pouch-anal anastomosis (IPAA) and the creation of a temporary loop ileostomy. CONCLUSIONS: With respect to the surgical treatment of classic FAP, restorative proctocolectomy (RPC) with ileal J-pouch construction can be regarded as an established standard procedure, despite controversy regarding various technical aspects. Minimally invasive strategies should be considered as an equivalent option compared to conventional techniques.

The impact of guided instrument insertion during laparoscopy: a randomized study with novices in an optical box trainer.

BACKGROUND: During laparoscopic operations, the trocars are often out of the viewing field of the laparoscope. Blind insertion of laparoscopic instruments is potentially dangerous especially when they are pointed or hot. A guidance of the instrument to the target point has the potential to improve the safety of instrument insertion. METHODS: In this study, the effect of a mechanical and an optical tool for guided instrument insertion into the abdominal cave was evaluated. The controlled prospective randomized study measured safety and efficiency of instrument insertion by 60 novices in an inanimate standardized box trainer. A post-test questionnaire based on the NASA Task Load Index prompted for the subjective impressions of the subjects. RESULTS: Instrument insertion with optical guidance showed a shorter (p = 0.002) insertion time (median 87.5 s for nine insertions) compared with blind insertion (median 112.0 s for nine insertions). The error number with optical guidance (median 0.5) was lower (p = 0.064) compared with blind insertion (median 1.0). The mechanical guidance showed a shorter (p = 0.001) insertion time (median 89.0 s for nine insertions) and less (p = 0.044) touch errors (median 0) compared with blind insertion. The results of the two guidance tools (mechanical vs. optical guidance) showed no significant difference. In the questionnaire, 89% of the novices subjectively judged the mechanical guidance tool better than blind insertion. The assessments of optical compared to mechanical guidance turned out quite similar. CONCLUSIONS: In the experimental setup, instrument insertion with a guidance tool performed faster and safer compared with blind insertion. The subjective assessments confirmed the benefit of instrument guidance.

Therapy of pessary-induced rectovaginal fistula and pelvic organ prolapse in elderly patients by vaginal approach and modified LeFort colpocleisis: a case series.

PURPOSE: Pelvic organ prolapse (POP) presents a common benign condition in women associated with reduced quality of life (QoL). The use of pessaries is considered a first-line treatment of POP. However, pessaries can cause perforations into adjacent organs resulting in fistulas. We present a series of three cases of rectovaginal fistulas (RVF) due to pessary perforation. METHODS: Three consecutive cases of pessary-induced RVF in patients with POP stage IV were assessed between September 2016 and September 2019. Consensus for therapeutic strategy was reached by an interdisciplinary board. RESULTS: The RVF were located in the posterior vaginal wall and had a diameter of up to 60 mm. In one of three patients, a two-step approach was chosen with the ostomy being performed at the same time as fistula closure and modified LeFort colpocleisis. It was followed by ostomy closure 3 months later. In two patients, a three-step approach was chosen with the ostomy performed separately due to a local tissue inflammation around RVF. Neither fistula nor POP recurrences have occurred so far. CONCLUSION: Combined temporary gastrointestinal diversion, RVF closure and POP therapy can be performed as a two- or three-stage approach. Lack of evidence and standardized algorithms in RVF therapy make further clinical studies essential. We encourage the preoperative assessment of any case of complex rectovaginal fistula by an interdisciplinary board for determining an individualized treatment.

Enterocutaneous fistula in severely active Crohn's disease: preoperative anti-TNF alpha treatment to limit bowel resection-report of a case.

PURPOSE: Strategies for limiting the extent of bowel resection in cases of enterocutaneous or interenteric fistulas in severely active Crohn's disease are urgently necessary. Anti-inflammatory therapy with tumor necrosis factor alpha (anti-TNF alpha) inhibitors has positive impact on fistulizing Crohn's disease. We describe a case of a 32-year-old male suffering from enterocutaneous fistula in severely active Crohn's disease. METHODS: The patient's clinical course and data of therapy monitoring before bowel resection were reviewed and compared to the pretherapeutic findings. In addition, the reports of surgery and histopathological workup were evaluated and a clinical follow-up was performed. The literature on anti-TNF alpha treatment in fistulizing Crohn's disease was surveyed. RESULTS: A 32-year-old male with an 8-year history of Crohn's disease and condition after previous ileocecal and sigmoid resection at the age of 28 presented with increasing pain in the middle-right abdomen. Laboratory and radiologic assessment detected elevated C-reactive protein and presence of a conglomerate of inflammatory thickened and narrowed small intestine involving the neoterminal ileum and enteroenteric fistulas. Ileocolonoscopy showed a stenosing inflammation of the neoterminal ileum. After initial anti-infective therapy, as a result of an interdisciplinary decision, preoperative anti-TNF alpha treatment was performed to achieve limited bowel resection. After declining of inflammation, limited bowel resection was carried out successfully. CONCLUSIONS: Preoperative therapy with anti-TNF alpha might potentially reduce inflammation to subsequently limit the extent of bowel resection in selected cases of enterocutaneous or interenteric fistulas in severely active Crohn's disease. We describe an impressive case in which such therapeutic approach was carried out.

[First Robotic Assisted Resection of a Retrorectal Tailgut Cyst - Video Case Report of a 27-Year-Old Female Patient]. / Roboterassistierte Resektion einer retrorektalen Tailgut-Zyste ­ erstbeschreibender Videofallbericht einer 27-jährigen Patientin.

PURPOSE: Tailgut cysts are a rare form of retrorectal tumours. They are also referred to as cystic hamartomas and predominantly affect female patients. Malignant transformation is thought to occur in 2 - 10% of cases, but there is scant further evidence. Besides the risk of malignant transformation, the feared complications include infection, difficulties in defecation, or potential dystocia necessitating in sano resection. INDICATION: We describe the case of a 27-year-old female patient presenting with a prolapsing round structure during defaecation. MRI, endosonography and transrectal drainage were carried out to exclude malignancy. We performed resection of the retrorectal tailgut cyst by robotic surgery. To the authors knowledge, this access has not previously been described for tailgut cyst resection. METHOD: Our video shows preoperative diagnostic testing, endoscopic drainage and robotic resection of the tailgut cyst. An intraoperative lesion of the dorsal rectum was successfully closed by suture. CONCLUSIONS: Different surgical techniques have been described for tailgut cyst resection. That with the widest application is posterior/sacral access, followed by abdominal and transrectal techniques. There are no published reports of robotic resection. We chose the robotic approach, as this is the surgeon's preferred technique for minimally invasive surgery of the pelvis.

Cost analysis of a wait-and-see strategy after radiochemotherapy in distal rectal cancer.

BACKGROUND: Nonoperative management (NOM) of rectal cancer after radiochemotherapy (RtChx) in patients with a clinical complete response is an emerging strategy with the goal to improve quality of life without compromising cure rates. However close monitoring with both magnetic resonance imaging (MRI) and rectoscopy is required for the early detection of possible local regrowths. We therefore performed a cost analysis comparing the costs of immediate surgery with the costs for MRI and rectoscopy during surveillance as in the upcoming CAO/ARO/AIO-16 trial. METHODS: MRIs and rectoscopies of patients with a clinical complete response after RtChx over the course of 5 years were simulated and compared with immediate surgery after RtChx. Transition probabilities between health stages (no evidence of disease, local regrowth and salvage surgery, distant failure) were derived from the literature. Costs for ambulatory imaging and endoscopic studies were calculated according to the "Gebührenordnung für Ärzte" (GOÄ), costs for surgery based on the diagnosis-related groups system. Three different scenarios with higher costs for salvage surgery or higher regrowth rates were simulated. RESULTS: A patient without disease recurrence will generate costs for MRI and rectoscopy of 6344 € over 5 years compared with costs of 14,511 € for immediate radical surgery. When 25% local regrowths with subsequent salvage surgery were included in the model, the average costs per patient are 8299 €. In our simulations a NOM strategy was cost-saving compared with immediate surgery in all three scenarios. CONCLUSION: A NOM strategy with an intensive surveillance using MRI and rectoscopy will produce costs that are expected to remain below those of immediate surgery.

Evaluation of self-educational training methods to learn laparoscopic skills - a randomized controlled trial.

BACKGROUND: Evaluation of two different self-educational methods (video assisted learning versus video assisted learning plus a nodal point operation primer) on learning laparoscopic suturing and intracorporal knotting. METHODS: Randomized controlled trial at the laparoscopic surgical training center, University of Tubingen with 45 surgical novices first year medical students being pretested for dexterity. After self-educational training for 90 min with either method (Group A: video assisted learning, Group B: video assisted learning plus a nodal point operation primer) participants had to perform five laparoscopic intracorporal knots. Assessed were number of knots completed (maximum of five knots counted, knot integrity, technical proficiency and knotting time per knot. Primary outcome measure is a composed knot score combining knot integrity, technical proficiency and knotting time. RESULTS: Group B (n = 23) achieved a significantly higher composed knot score than Group A (n = 22) (53.3 ± 8.4 versus 46.5 ± 13.6 points respectively, p = 0.016). Median knotting time per completed knot was significantly different between Group B and Group A (308 s [100-1221] versus 394 s [138-1397] respectively, p = 0.001). Concerning number of completed knots there was a trend towards more knots achieved in Group B (4.2 ± 1.2 versus 3.55 ± 1.4 respectively, p = 0.075) . CONCLUSIONS: The use of a nodal point operation primer highlighting essential key steps of a procedure augment the success of learning laparoscopic skills as suturing and intracorporal knotting. (UIN researchregistry3866, March 22, 2018).

How Much Stereoscopic Effect Does Laparoscopy Need? Controlled, Prospective Randomized Trial on Surgical Task Efficiency in Standardized Phantom Tasks.

BACKGROUND: To regain 2-eyed vision in laparoscopy, dual-channeled optics have been introduced. With this optics design, the distance between the 2 front lenses defines how much stereoscopic effect is seen. This study quantifies the impact of an enhanced and a reduced stereo effect on surgical task efficiency. METHODS: A prospective single-blinded study was performed with 20 laparoscopic novices in an inanimate experimental setting. A standard bichannelled stereo system was used to perform a suturing and knotting task. The working distance and the task size were scaled to vary the stereo effect and, thereby, simulate hypothetic stereo optics with enhanced and reduced optical bases. The task performances were timed, and the number of trials for stitching out was counted. The participants finally filled out a questionnaire to collect subjective impressions. RESULTS: The increase of the stereo effect by 50% caused no objective improvement in laparoscopic knotting compared with typical 3D (control group with stereo basis of 4.5 mm). But ergonomic disadvantages (headache) were subjectively reported in 1 of 20 cases in the questionnaire. The reduction of the stereo effect by one-third led to a significantly longer average execution time. There was no significant dependence found between stereo effect and number of stich-out trials, stitching precision, or knotting quality. CONCLUSIONS: Considering laparoscopy, it does not seem advisable to enhance the stereo effect because of ergonomic problems. Otherwise, a miniaturization of the 3D scope (5 mm version) is problematic because its benefit mostly shrinks with the reduced stereo effect.

Low-grade appendiceal mucinous neoplasm (LAMN) - 3-year endoscopic follow-up underlines benign course of LAMN type 1.

Low-grade appendiceal mucinous neoplasms (LAMNs) are neoplastic lesions with potential progression to pseudomyxoma peritonei (PMP). In most cases, diagnosis is made because of suspected acute appendicitis or incidentally by computed tomography (CT). However, incidental diagnosis during colonoscopy is rare. We present the case of a 63-year-old man with a LAMN type 1 lesion, diagnosed at routine colonoscopy for surveillance of ulcerative colitis. Because in earlier surveillance colonoscopies, this lesion was misinterpreted as fecal polution, for the first time, this case describes retrospectively a 3-year endoscopic follow-up of LAMN type 1, underlining the benign course of these kind of lesions compared to type 2 lesions with submucosal infiltration. Even though endoscopy and sonography are not accepted as method of choice to detect LAMN lesions, our case highlights their role regarding diagnosis of small lesions, as CT scan was not able to detect the lesion in our case. Even though LAMNs are rare, awareness of LAMN lesions in routine colonoscopy is favorable as potential progression to PMP can not be ruled out.

Compliance of Clinical Pathways in Elective Laparoscopic Cholecystectomy: Evaluation of Different Implementation Methods.

BACKGROUND: Clinical pathways aim to standardize perioperative and postoperative care of surgical procedures and are shown to result in a significant optimization associated with cost reduction. The aim of this study was to establish the impact of two different implementations forms of clinical pathways on the pathway compliance and resulting costs. METHODS: Data of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were collected over two different periods: using a clinical pathway in the form of a paper-based checklist, or a clinical pathway integrated into the paper-based medical treatment and nursing documentation. Outcome measures were compliance of the clinical pathway and total costs per case. RESULTS: The compliance was significantly higher using integrated pathways compared to paper-based checklists (n = 117 of 123, 95 % vs 54 of 118, 46 %; p < 0.001). Mean total costs (€2206 vs €2458, p = 0.027) and length of hospital stay (2.13 vs 2.77 days, p < 0.001) were significantly reduced by the integrated clinical pathway compared to checklists. Further, the variation of costs per case and variation of length of hospital stay were significantly smaller with integrated clinical pathway (±€440 vs ±€538, p = 0.039 and ±0.53 vs ±0.68 days, p < 0.001, respectively). No difference regarding postoperative complication was observed (n = 3 vs. 4 events; p = 0.67). CONCLUSION: Integrated clinical pathways display a significant higher compliance compared to checklists resulting in reduced total costs, shorter hospital stay and a smaller variation of cost, making it a useful tool in process controlling and planning.

Anorectal malignant melanoma: curative abdominoperineal resection: patient selection with 18F-FDG-PET/CT.

BACKGROUND: Anorectal malignant melanomas (ARMM) are rare tumors, characterized by an early lymphatic spread and distant metastasis, resulting in an extremely poor overall survival. The objective of this study was to determine the pattern of regional lymph node metastasis (LNM) by computed tomography (CT) and 18F-FDG-PET/CT in patients undergoing abdominoperineal resection (APR) and its impact on oncologic outcome. METHODS: A retrospective analysis of six consecutive patients who underwent APR due to primary ARMM was performed. Patients were staged by CT and PET/CT. RESULTS: Four out of six patients had preoperative LNM involvement (two patients inguinal and perirectal, one iliacal, one perirectal), with two of them presenting with distant metastases additionally. Inguinal/iliacal LNM in two patients as well as liver metastasis in one patient was seen in PET/CT and missed by CT. The three patients with initial inguinal/iliacal LNM died during the observation period (overall survival: 10 (6-18) months). The three patients without inguinal/iliacal LNM involvement are currently alive, one patient showing a slowly progressive disease since 5 years, and two patients are tumor-free since 8.5 and 1.5 years (the patients had initial perirectal LNM). CONCLUSIONS: In ARMM, PET/CT is superior to CT in detection of LNM and distant metastasis. APR is possibly a curative approach if the PET/CT shows exclusively perirectal LNM despite locally advanced tumor growth.

Rapid thyroid nodule growth is not a marker for well-differentiated thyroid cancer.

BACKGROUND: Rapid growth of thyroid nodules is described as being associated with thyroid cancer. The objective of the study was to determine how the growth rate of thyroid nodules during follow-up is associated with the risk of thyroid cancer. METHODS: Retrospective analysis of patients undergoing thyroid surgery for nodular disease and a repetitive preoperative ultrasound work-up of at least 6 months was done. Nodule growth was considered relevant when a volume increase >49% was detected. Growth patterns were described as rapid for a volume increase present over 6 to 24 months. RESULTS: Of the 297 analysed patients, 226 (76%) displayed relevant nodule growth and 71 (24%) no relevant growth. A rapid growth pattern was seen in 73 patients (32%). Well-differentiated thyroid cancer was diagnosed in 33 patients (11%; 27 papillary, 6 follicular) with a relevant nodule growth in 2 and no relevant growth in 31 patients. No rapid growth pattern was observed in any case of well-differentiated thyroid cancer. A rapid growth pattern occurred only in benign nodules (70 patients) and in 1 patient each with a lymphoma, a metastasis of a renal cell cancer and a metastasis of a gastric adenocarcinoma. Therapy with levothyroxine and/or iodine was administered to 129 patients (43%) and was significantly inversely correlated with nodule growth (odds ratio 0.27; CI 95 % 0.14-0.53, p < 0.001). CONCLUSIONS: Thyroid nodule growth alone and especially a rapid growth pattern during follow-up for thyroid nodular disease is not a marker for well-differentiated thyroid cancer and should not be used as a stand-alone argument for thyroid surgery.

Diagnostic accuracy of hyperbilirubinaemia in anticipating appendicitis and its severity.

BACKGROUND: Hyperbilirubinaemia is reported to be a positive predictor in diagnosing appendicitis and especially appendiceal perforation. We, therefore, analysed the diagnostic accuracy of serum bilirubin in anticipating appendicitis and its severity. METHODS: All consecutive patients undergoing appendectomy for suspected appendicitis from May 2009 to August 2011 were analysed. Patients were classified based on final histopathological findings into the groups: no appendiceal inflammation, non-perforated appendicitis and perforated appendicitis. Primary outcome was the diagnostic accuracy of serum bilirubin levels in discriminating between no appendiceal inflammation and any appendicitis (perforated and non-perforated appendicitis) and non-perforated and perforated appendicitis. RESULTS: Of 493 analysed patients, 125 (25%) had no appendiceal inflammation, 312 (64%) had non-perforated appendicitis and 56 (11%) had perforated appendicitis. The proportion of patients with bilirubin elevation (>1.1 mg/dL) was different between those with no appendiceal inflammation (14%) and any appendicitis (36%) (p<0.0001), and between non-perforated appendicitis and perforated appendicitis 48% (p=0.04). However, the positive and negative likelihood ratios (LRs) for an elevated bilirubin were poor at discriminating the groups: no appendiceal inflammation versus any appendicitis (LR+ 2.62 (95% CI 1.65 to 4.16) and LR- 0.75 (95% CI 0.67 to 0.83)) and non-perforated appendicitis versus perforated appendicitis (LR+ estimate 1.74 (95% CI 1.28 to 2.38) and LR- 0.72 (95% CI 0.55 to 0.93)). CONCLUSIONS: Hyperbilirubinaemia is present in acute appendicitis but has a low diagnostic accuracy in discriminating between any appendicitis versus no appendiceal inflammation and perforated versus non-perforated appendicitis and is, therefore, of limited value in clinical routine. TRIAL REGISTRATION NUMBER: NCT01698099.