The INCH-trial: a multicenter randomized controlled trial comparing short- and long-term outcomes of open and laparoscopic surgery for incisional hernia repair.

BACKGROUND: Laparoscopic incisional hernia repair is increasingly performed worldwide and expected to be superior to conventional open repair regarding hospital stay and quality of life (QoL). The INCisional Hernia-Trial was designed to test this hypothesis. METHODS: A multicenter parallel randomized controlled open-label trial with a superiority design was conducted in six hospitals in the Netherlands. Patients with primary or recurrent incisional hernias were randomized by computer-guided block-randomization to undergo either conventional open or laparoscopic repair. Primary endpoint was postoperative length of hospital stay in days. Secondary endpoints included QoL, complications, and recurrences. Patients were followed up for at least 5 years. RESULTS: Hundred-and-two patients were recruited and randomized. In total, 88 patients underwent surgery and were included in the intention-to-treat analysis (44 in the open group, 44 in the laparoscopic group). Mean age was 59.5 years, gender division was equal, and BMI was 28.8 kg/m. The trial was concluded early for futility after an unplanned interim analysis, which showed that the hypothesis needed to be rejected. There was no difference in primary outcome: length of hospital stay was 3 (range 1-36) days in the open group and 3 (range 1-12) days in the laparoscopic group (p = 0.481). There were no significant between-group differences in QoL questionnaires on the short and long term. Satisfaction was impaired in the open group. Overall recurrence rate was 19%, of which 16% in the open and 23% in the laparoscopic group (p = 0.25) at a mean follow-up of 6.6 years. CONCLUSIONS: In a randomized controlled trial, short- and long-term outcomes after laparoscopic incisional hernia repair were not superior to open surgery. The persisting high recurrence rates, reduced QoL, and suboptimal satisfaction warrant the need for patient's expectation management in the preoperative process and individualized surgical management. TRIAL REGISTRATION: Netherlands Trial Register NTR2808.

Which, how, and what? Using digital tools to train surgical skills; a systematic review and meta-analysis.

Background: Digital tools like digital box trainers and VR seem promising in delivering safe and tailored practice opportunities outside of the surgical clinic, yet understanding their efficacy and limitations is essential. This study investigated Which digital tools are available to train surgical skills, How these tools are used, How effective they are, and What skills they are intended to teach. Methods: Medline, Embase, and Cochrane libraries were systematically reviewed for randomized trials, evaluating digital skill-training tools based on objective outcomes (skills scores and completion time) in surgical residents. Digital tools effectiveness were compared against controls, wet/dry lab training, and other digital tools. Tool and training factors subgroups were analysed, and studies were assessed on their primary outcomes: technical and/or non-technical. Results: The 33 included studies involved 927 residents and six digital tools; digital box trainers, (immersive) virtual reality (VR) trainers, robot surgery trainers, coaching and feedback, and serious games. Digital tools outperformed controls in skill scores (SMD 1.66 [1.06, 2.25], P < 0.00001, I2 = 83 %) and completion time (SMD -1.05 [-1.72, -0.38], P = 0.0001, I2 = 71 %). There were no significant differences between digital tools and lab training, between tools, or in other subgroups. Only two studies focussed on non-technical skills. Conclusion: While the efficacy of digital tools in enhancing technical surgical skills is evident - especially for VR-trainers -, there is a lack of evidence regarding non-technical skills, and need to improve methodological robustness of research on new (digital) tools before they are implemented in curricula. Key message: This study provides critical insight into the increasing presence of digital tools in surgical training, demonstrating their usefulness while identifying current challenges, especially regarding methodological robustness and inattention to non-technical skills.

Can Quality Improvement Methodologies Derived from Manufacturing Industry Improve Care in Cardiac Surgery? A Systematic Review.

OBJECTIVES: Healthcare is required to be effectively organised to ensure that growing, aging and medically more complex populations have timely access to high-quality, affordable care. Cardiac surgery is no exception to this, especially due to the competition for and demand on hospital resources, such as operating rooms and intensive care capacity. This is challenged more since the COVID-19 pandemic led to postponed care and prolonged waiting lists. In other sectors, Quality Improvement Methodologies (QIM) derived from the manufacturing industry have proven effective in enabling more efficient utilisation of existing capacity and resources and in improving the quality of care. We performed a systematic review to evaluate the ability of such QIM to improve care in cardiac surgery. METHODS: A literature search was performed in PubMed, Embase, Clarivate Analytics/Web of Science Core Collection and Wiley/the Cochrane Library according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis methodology. RESULTS: Ten articles were identified. The following QIM were used: Lean, Toyota Production System, Six Sigma, Lean Six Sigma, Root Cause Analysis, Kaizen and Plan-Do-Study-Act. All reported one or more relevant improvements in patient-related (e.g., infection rates, ventilation time, mortality, adverse events, glycaemic control) and process-related outcomes (e.g., shorter waiting times, shorter transfer time and productivity). Elements to enhance the success included: multidisciplinary team engagement, a patient-oriented, data-driven approach, a sense of urgency and a focus on sustainability. CONCLUSIONS: In all ten papers describing the application of QIM initiatives to cardiac surgery, positive results, of varying magnitude, were reported. While the consistency of the available data is encouraging, the limited quantity and heterogenous quality of the evidence base highlights that more rigorous evaluation, including how best to employ manufacturing industry-derived QIM in cardiac surgery is warranted.

International Delphi Expert Consensus on Safe Return to Surgical and Endoscopic Practice: From the Coronavirus Global Surgical Collaborative.

OBJECTIVE: The aim of this work is to formulate recommendations based on global expert consensus to guide the surgical community on the safe resumption of surgical and endoscopic activities. BACKGROUND: The COVID-19 pandemic has caused marked disruptions in the delivery of surgical care worldwide. A thoughtful, structured approach to resuming surgical services is necessary as the impact of COVID-19 becomes better controlled. The Coronavirus Global Surgical Collaborative sought to formulate, through rigorous scientific methodology, consensus-based recommendations in collaboration with a multidisciplinary group of international experts and policymakers. METHODS: Recommendations were developed following a Delphi process. Domain topics were formulated and subsequently subdivided into questions pertinent to different aspects of surgical care in the COVID-19 crisis. Forty-four experts from 15 countries across 4 continents drafted statements based on the specific questions. Anonymous Delphi voting on the statements was performed in 2 rounds, as well as in a telepresence meeting. RESULTS: One hundred statements were formulated across 10 domains. The statements addressed terminology, impact on procedural services, patient/staff safety, managing a backlog of surgeries, methods to restart and sustain surgical services, education, and research. Eighty-three of the statements were approved during the first round of Delphi voting, and 11 during the second round. A final telepresence meeting and discussion yielded acceptance of 5 other statements. CONCLUSIONS: The Delphi process resulted in 99 recommendations. These consensus statements provide expert guidance, based on scientific methodology, for the safe resumption of surgical activities during the COVID-19 pandemic.

Safe cholecystectomy multi-society practice guideline and state-of-the-art consensus conference on prevention of bile duct injury during cholecystectomy.

BACKGROUND: Bile duct injury (BDI) is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe cholecystectomy and prevention of BDI. METHODS: Literature reviews were conducted for 18 key questions across six broad topics around cholecystectomy directed by a steering group and subject experts from five surgical societies (SAGES, AHPBA IHPBA, SSAT, and EAES). Evidence-based recommendations were formulated using the GRADE methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus. RESULTS: Consensus was reached on 17 of 18 questions by the Guideline Development Group (GDG) and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team. CONCLUSION: These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.

Safe Cholecystectomy Multi-society Practice Guideline and State of the Art Consensus Conference on Prevention of Bile Duct Injury During Cholecystectomy.

BACKGROUND: BDI is the most common serious complication of laparoscopic cholecystectomy. To address this problem, a multi-society consensus conference was held to develop evidenced-based recommendations for safe cholecystectomy and prevention of BDI. METHODS: Literature reviews were conducted for 18 key questions across 6 broad topics around cholecystectomy directed by a steering group and subject experts from 5 surgical societies (Society of Gastrointestinal and Endoscopic Surgeons, Americas Hepato-Pancreato-Biliary Association, International Hepato-Pancreato-Biliary Association, Society for Surgery of the Alimentary Tract, and European Association for Endoscopic Surgery). Evidence-based recommendations were formulated using the grading of recommendations assessment, development, and evaluation methodology. When evidence-based recommendations could not be made, expert opinion was documented. A number of recommendations for future research were also documented. Recommendations were presented at a consensus meeting in October 2018 and were voted on by an international panel of 25 experts with greater than 80% agreement considered consensus. RESULTS: Consensus was reached on 17 of 18 questions by the guideline development group and expert panel with high concordance from audience participation. Most recommendations were conditional due to low certainty of evidence. Strong recommendations were made for (1) use of intraoperative biliary imaging for uncertainty of anatomy or suspicion of biliary injury; and (2) referral of patients with confirmed or suspected BDI to an experienced surgeon/multispecialty hepatobiliary team. CONCLUSIONS: These consensus recommendations should provide guidance to surgeons, training programs, hospitals, and professional societies for strategies that have the potential to reduce BDIs and positively impact patient outcomes. Development of clinical and educational research initiatives based on these recommendations may drive further improvement in the quality of surgical care for patients undergoing cholecystectomy.

Correction to: Consensus on international guidelines for management of groin hernias.

In the Acknowledgments, Lars N. Jorgensen of the HerniaSurge Group was incorrectly listed as: "Lars Jorgensen, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark." The correct listing should have read: "Lars N. Jorgensen, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark."

Consensus on international guidelines for management of groin hernias.

BACKGROUND: Groin hernia management has a significant worldwide diversity with multiple surgical techniques and variable outcomes. The International guidelines for groin hernia management serve to help in groin hernia management, but the acceptance among general surgeons remains unknown. The aim of our study was to gauge the degree of agreement with the guidelines among health care professionals worldwide. METHODS: Forty-six key statements and recommendations of the International guidelines for groin hernia management were selected and presented at plenary consensus conferences at four international congresses in Europe, the America's and Asia. Participants could cast their votes through live voting. Additionally, a web survey was sent out to all society members allowing online voting after each congress. Consensus was defined as > 70% agreement among all participants. RESULTS: In total 822 surgeons cast their vote on the key statements and recommendations during the four plenary consensus meetings or via the web survey. Consensus was reached on 34 out of 39 (87%) recommendations, and on six out of seven (86%) statements. No consensus was reached on the use of light versus heavy-weight meshes (69%), superior cost-effectiveness of day-case laparo-endoscopic repair (69%), omitting prophylactic antibiotics in hernia repair, general or local versus regional anesthesia in elderly patients (55%) and re-operation in case of immediate postoperative pain (59%). CONCLUSION: Globally, there is 87% consensus regarding the diagnosis and management of groin hernias. This provides a solid basis for standardizing the care path of patients with groin hernias.

A new modular mechanism that allows full detachability and cleaning of steerable laparoscopic instruments.

BACKGROUND: Ever since the introduction of laparoscopic surgery, researchers have been trying to add steerability to instruments to allow the surgeon to operate with better reachability and less tissue interaction force. Traditional solutions to introduce this often use a combination of springs, cables, pulleys, and guiding structures, resulting in instruments that cannot be properly cleaned and thus are very costly to manufacture and maintain. The aim of the study is to develop a novel affordable, sustainable, cableless, and fully steerable laparoscopic grasper, and to test its ease of assembly, disassembly, and use. METHODS: A set of requirements was defined to ensure that the instrument can be handled efficiently at the sterilization unit and in the operating room. Based on these, a multisteerable, cableless 5 mm laparoscopic instrument that operates based on shaft rotations was developed. To test its assembly and disassembly, ten participants were asked to fully dismantle the instrument and reassemble it a total of 60 times. In addition, ten medical students were asked to use the grasper in the ForceSense box-trainer system on a newly developed 3D pick-and-place task, to determine the control effort based on learning curves of steering errors, task time, instrument path length, and maximum tissue interaction force. RESULTS: All important design requirements were met. The recorded data indicates that ten engineering students were able to fully dismantle and reassemble the instrument shaft in 12 s (SD7) and 65 s (SD43) seconds at the sixth attempt. The learning-curve data indicates that three attempts were needed before the ten medical students started to use all steering functions. At the sixth attempt, on average only 1.25 (SD0.7) steering errors were made. The steepest slope in the learning curves for steering errors, path length, and task time was experienced during the first three attempts. In respect of the interaction force, no learning effect was observed. CONCLUSION: The multi-DOF (degree of freedom) cableless grasper can be assembled and disassembled for cleaning and sterilization within an acceptable time frame. The handle interface proved to be intuitive enough for novices to conduct a complex 3D pick-and-place task in a training setting.

Spillage of bacterial products during colon surgery increases the risk of liver metastases development in a rat colon carcinoma model.

Surgical resection of the primary tumor provides the best chance of cure for patients with colorectal carcinoma (CRC). However, bacterial translocation during intestinal surgery has been correlated with poor long-term oncological outcome. Therefore, we investigated the influence of bacterial contamination during colon surgery on CRC liver metastases development. Blood and liver samples of patients undergoing resection of primary CRC or liver metastases were collected. Cell numbers, activation markers and inflammatory mediators were determined. Tumor cell adhesion and outgrowth after sham- or colectomy operations were determined in a rat model, in which tumor cells had been injected into the portal vein. White blood cells and granulocytes were increased in per- and post-operative patient blood samples. IL-6 was also increased post-operatively compared to the preoperative level. Expression of NOX-2, NOX-4 and polymorphonuclear cells (PMNs) numbers were elevated in post-operative human liver samples. In vitro stimulation of macrophages with plasma of rats after colectomy resulted in production of reactive oxygen species (ROS). Colectomy in rats increased D-lactate levels in plasma, supporting bacterial translocation. Decreased expression of tight junction molecules and increased tumor cell adhesion and outgrowth was observed. Treatment with a selective decontamination of the digestive tract (SDD) cocktail decreased tumor cell adherence after colectomy. In conclusion, postoperative bacterial translocation may activate liver macrophages and PMNs, resulting in ROS production. As we previously showed that ROS release led to liver vasculature damage, circulating tumor cells may adhere to exposed extracellular matrix and grow out into liver metastases. This knowledge is pivotal for development of therapeutic strategies to prevent surgery-induced liver metastases development.

Health economic analysis of costs of laparoscopic and open surgery for rectal cancer within a randomized trial (COLOR II).

BACKGROUND: Previous studies regarding the comparative costs of laparoscopic and open surgery for rectal cancer provide ambiguous conclusions, and there are no large randomized trials or long-term follow-up. METHODS: A prospective cost-minimization analysis was carried out by using data of clinical resource use from the randomized controlled trial COLOR II. Some data needed for the health economic evaluation were not collected in the clinical trial; therefore, a retrospective data collection was made for COLOR II-patients operated at the largest participating Swedish hospital (n = 105). Sick leave information was provided by the Swedish social insurance agency. Unit costs were collected from Swedish sources. The primary outcome was the difference in mean cost between laparoscopic and open surgery. RESULTS: The COLOR II-trial enrolled 1044 rectal cancer patients randomized between laparoscopic and open surgery 2:1. At the 3-year follow-up data for the clinical variables used in the analysis were available for 74-89 % of patients. Laparoscopic surgery costs the health care sector more than the open technique, both at 28 days ($1910, 95 % CI 677-3143) and 3 years ($3854, 95 % CI 1527-6182) after surgery. There were, however, no differences in long-term costs to society between laparoscopic and open surgery ($684, 95 % CI -5799 to 7166). CONCLUSIONS: Though the study found short- and long-term cost differences for the healthcare sector, there was no difference in regard to the long-term societal perspective. Future research is suggested to investigate the effects of sick leave costs using material from a greater number of patients.

Diagnosis and management of acute appendicitis. EAES consensus development conference 2015.

Unequivocal international guidelines regarding the diagnosis and management of patients with acute appendicitis are lacking. The aim of the consensus meeting 2015 of the EAES was to generate a European guideline based on best available evidence and expert opinions of a panel of EAES members. After a systematic review of the literature by an international group of surgical research fellows, an expert panel with extensive clinical experience in the management of appendicitis discussed statements and recommendations. Statements and recommendations with more than 70 % agreement by the experts were selected for a web survey and the consensus meeting of the EAES in Bucharest in June 2015. EAES members and attendees at the EAES meeting in Bucharest could vote on these statements and recommendations. In the case of more than 70 % agreement, the statement or recommendation was defined as supported by the scientific community. Results from both the web survey and the consensus meeting in Bucharest are presented as percentages. In total, 46 statements and recommendations were selected for the web survey and consensus meeting. More than 232 members and attendees voted on them. In 41 of 46 statements and recommendations, more than 70 % agreement was reached. All 46 statements and recommendations are presented in this paper. They comprise topics regarding the diagnostic work-up, treatment indications, procedural aspects and post-operative care. The consensus meeting produced 46 statements and recommendations on the diagnostic work-up and management of appendicitis. The majority of the EAES members supported these statements. These consensus proceedings provide additional guidance to surgeons and surgical residents providing care to patients with appendicitis.

[Transanal total mesorectal excision: a new treatment option for rectal cancer]. / Transanale totale mesorectale excisie: een nieuwe behandeling voor het rectumcarcinoom.

The transanal total mesorectal excision (TME) for colorectal tumours is a new endoscopic approach in which the rectum is mobilized transanally from down-to-up using a flexible transanal single-access port. The advantage of this technique is that it could result in fewer conversions from laparoscopic to open procedures and consequently fewer complications and more radical resections. Standard endoscopic armamentarium is used for the transanal technique so that costs remain low. The length of the learning curve is expected to be comparable to other laparoscopic techniques, and is even shorter for an experienced laparoscopic surgeon. Additional research is needed to compare long-term oncological and clinical results of transanal TME to laparoscopic and open TME.

The INCH-Trial: a multicentre randomized controlled trial comparing the efficacy of conventional open surgery and laparoscopic surgery for incisional hernia repair.

BACKGROUND: Annually approximately 100.000 patients undergo a laparotomy in the Netherlands. About 15,000 of these patients will develop an incisional hernia. Both open and laparoscopic surgical repair have been proven to be safe. However, the most effective treatment of incisional hernias remains unclear. This study, the 'INCH-trial', comparing cost-effectiveness of open and laparoscopic incisional hernia repair, is therefore needed. METHODS/DESIGN: A randomized multi-center clinical trial comparing cost-effectiveness of open and laparoscopic repair of incisional hernias. Patients with a symptomatic incisional hernia, eligible for laparoscopic and open incisional hernia repair. Only surgeons, experienced in both open and laparoscopic incisional hernia repair, will participate in the INCH trial. During incisional hernia repair, a mesh is placed under or on top of the fascia, with a minimal overlap of 5 cm. Primary endpoint is length of hospital stay after an incisional hernia repair. Secondary endpoints are time to full recovery within three months after index surgery, post-operative complications, recurrences, mortality and quality of life.Our hypothesis is that laparoscopic incisional hernia repair comes with a significant shorter hospital stay compared to open incisional hernia repair. A difference of two days is considered significant. One-hunderd-and-thirty-five patients are enrolled in each treatment arm. The economic evaluation will be performed from a societal perspective. Primary outcomes are costs per patient related to time-to-recovery and quality of life.The main goal of the trial is to establish whether laparoscopic incisional hernia repair is superior to conventional open incisional hernia repair in terms of cost-effectiveness. This is measured through length of hospital stay and quality of life. Secondary endpoints are re-operation rate due to post-operative complications or recurrences, mortality and quality of life. DISCUSSION: The difference in time to full recovery between the two treatment strategies is thought to be in favor of laparoscopic incisional hernia repair. Laparoscopic incisional hernia repair is therefore expected to be a more cost-effective approach. TRIAL REGISTRATION: Netherlands Trial register: NTR2808.

Bowel obstruction after laparoscopic and open colon resection for cancer: results of 5 years of follow-up in a randomized trial.

BACKGROUND: Postoperative bowel obstruction caused by intra-abdominal adhesions occurs after all types of abdominal surgery. It has been suggested that the laparoscopic technique should reduce the risk for adhesion formation and thus for postoperative bowel obstruction. This study was designed to compare the incidence of bowel obstruction in a randomized trial where laparoscopic and open resection for colon cancer was compared. METHODS: A retrospective analysis was performed, collecting data of episodes of bowel obstruction with or without surgery. Only episodes treated in the hospital where the index surgery took place were included. Data for 786 patients were collected for the 5-year period after cancer surgery. RESULTS: Baseline characteristics for the evaluated laparoscopic (n = 383) and open (n = 403) groups were comparable. The cumulative obstruction percentages at 5 years for the open and laparoscopic groups were 6.5 and 5.1% respectively and did not significantly differ from each other. Tumor stage seemed to influence the risk for bowel obstruction: 2.8% in stage I, 6.6% in stage II, and 7% in stage III, but the differences were not significant. CONCLUSIONS: This analysis does not support the hypothesis that laparoscopy leads to fewer episodes of bowel obstruction compared with open surgery.

Is right laparoscopic donor nephrectomy right?

INTRODUCTION: Laparoscopic donor nephrectomy has become the standard of care in many renal transplant centers. Many centers are reluctant to perform right laparoscopic donor nephrectomies, primarily due to concerns about transplanting a kidney with a short renal vein. METHODS: A retrospective review of 26 right and 24 left consecutive donor nephrectomies and their recipients was performed. Patient demographics, preoperative, perioperative, and postoperative data were recorded and compared. RESULTS: Patient demographics were similar between groups. Multiple vessels were encountered more frequently on the right side (10 vs. 3, p = 0.04) and the donated kidney had lesser preoperative function in the right group as determined by nuclear medicine imaging (46.5% vs. 49.4%, p < 0.001). Donor operating times were less in the right group (198 vs. 226 min, p = 0.016). There was no difference in implantation difficulty as demonstrated by similar operative and warm ischemia times. Complication rates were similar between both groups of donors and recipients. CONCLUSIONS: Right laparoscopic donor nephrectomy requires less operating time than, and is associated with similar outcomes for donors and recipients as, left laparoscopic donor nephrectomy. Right laparoscopic donor nephrectomy may be preferable in general and should be considered when multiple renal vessels are present on the left side and/or when preoperative function of the left kidney is greater than the right.

Long-term outcome of laparoscopic surgery for colorectal cancer: a cochrane systematic review of randomised controlled trials.

BACKGROUND: The aim of this systematic review is to evaluate long-term outcome of laparoscopically assisted versus open surgery for non-metastasised colorectal cancer. METHODS: Cochrane library, EMBASE, Pub med and CancerLit were searched for published and unpublished randomised controlled trials. RevMan 4.2 was used for statistical analysis. RESULTS: Twelve trials (3346 patients) reported long-term outcome and were included in the current analyses. No significant differences were found between laparoscopic and open surgery in the occurrence of incisional hernias or the number of reoperations for adhesions (p=0.32 and 0.30, respectively). Port-site metastases and wound recurrences were rare and no differences in occurrence after laparoscopic and open surgery were observed (p=0.16). Cancer-related mortality at maximum follow-up was similar after laparoscopic and open surgery (p=0.15 and 0.16 for colon and rectal cancer, respectively). No significant difference in tumour recurrence after laparoscopic and open surgery for colon cancer was observed (3 RCTs, hazard ratio for tumour recurrence in the laparoscopic group 0.86; 95% CI 0.70-1.08). In colon cancer patients, no significant differences in overall mortality were found (2 RCTs, hazard ratio for overall mortality after laparoscopic surgery 0.86; 95% CI 0.86-1.07). CONCLUSIONS: Laparoscopic resection of carcinoma of the colon is associated with a long-term outcome that is similar to that after open colectomy. Laparoscopic surgery for cancer of the upper rectum is feasible, but more randomised trials need to be conducted to assess long-term outcome.

Novel criteria for parathyroid hormone levels in parathyroid hormone-guided parathyroid surgery.

CONTEXT: Novel criteria for decrease of perioperative parathyroid hormone measurement may improve the accuracy of perioperative quick parathyroid hormone (qPTH)-guided parathyroidectomy. OBJECTIVE: To assess overall cure rate based on conventional criteria (50% decline of qPTH). Perioperative qPTH levels were evaluated to determine novel criteria for successful parathyroid surgery. DESIGN: Analysis of perioperative qPTH measurement findings of all consecutive patients undergoing parathyroidectomy for hyperparathyroidism (72 with primary hyperparathyroidism and 28 with secondary or tertiary hyperparathyroidism or multiple endocrine neoplasia I/IIa disease). RESULTS: Measurement of qPTH (based solely on the criterion of greater than 50% decline of parathyroid hormone) in 72 patients with primary hyperparathyroidism (77 procedures) showed true-positive results in 69, false-positive results in 4, and true-negative results in 4 procedures. In our series, false-positive and true-negative results were associated with high postexcision levels. However, when qPTH declines of greater than 70% and 80% were used in cases of postexcision qPTH levels of 100 to 200 ng/L and greater than 200 ng/L, respectively, no false-positive results were observed. CONCLUSIONS: Through adherence to these novel criteria, reexploration of the neck could have been prevented in 29% of patients with primary hyperparathyroidism due to multiple gland disease. These novel criteria demand future evaluation to establish their value.