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.

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.

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.

[Healthcare cost reimbursement without application-Experiences of a German bariatric service].

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.

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).

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.

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.

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.

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.

Variplex™ test system fails to reliably detect SARS-CoV-2 directly from respiratory samples without RNA extraction.

Diagnosis of COVID is performed by PCR methods, but their capacity is limited by the requirement of high-level facilities and instruments. The loop-mediated isothermal amplification (LAMP) method has been utilized for the detection of isolated virus-specific RNA. Preliminary data suggest the possibility of isothermal amplification directly from respiratory samples without RNA extraction.

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.

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.

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.

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.

Delayed primary closure of contaminated abdominal wall defects with non-crosslinked porcine acellular dermal matrix compared with conventional staged repair: a retrospective study.

Introduction: Synthetic mesh has been used traditionally to repair abdominal wall defects, but its use is limited in the case of bacterial contamination. New biological materials are now being used successfully for delayed primary closure of contaminated abdominal wall defects. The costs of biological materials may prevent surgeons from using them.

[Traumatic thyroid rupture: case report and review of the literature].

Background: Traumatic rupture of the thyroid gland is rare. A common approach does not exist. Surgical and nonsurgical management have been advocated.

Acute renal artery aneurysm rupture - a rare differential diagnosis of acute appendicitis.

A 50-year-old patient with symptoms of an acute appendicitis turns out to be suffering of a life threatening rupture of a renal artery aneurysm. We performed an emergency operation with the resection of this aneurysm. An imminent hemorrhagic shock made a targeted intensive medical therapy necessary.

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.

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.

Invisible scar endoscopic dorsal approach thyroidectomy: a clinical feasibility study.

Background: The aim of the present study was to test the safety and feasibility of the dorsal approach endoscopic thyroidectomy procedure in a prospective trial in humans, after the procedure had been developed ex vivo in human cadavers.

Methods: A total of 28 patients were enrolled for 30 unilateral procedures of thyroidectomy. Two cases were staged bilateral procedures.