The 2023 WSES guidelines on the management of trauma in elderly and frail patients.

BACKGROUND: The trauma mortality rate is higher in the elderly compared with younger patients. Ageing is associated with physiological changes in multiple systems and correlated with frailty. Frailty is a risk factor for mortality in elderly trauma patients. We aim to provide evidence-based guidelines for the management of geriatric trauma patients to improve it and reduce futile procedures. METHODS: Six working groups of expert acute care and trauma surgeons reviewed extensively the literature according to the topic and the PICO question assigned. Statements and recommendations were assessed according to the GRADE methodology and approved by a consensus of experts in the field at the 10th international congress of the WSES in 2023. RESULTS: The management of elderly trauma patients requires knowledge of ageing physiology, a focused triage, including drug history, frailty assessment, nutritional status, and early activation of trauma protocol to improve outcomes. Acute trauma pain in the elderly has to be managed in a multimodal analgesic approach, to avoid side effects of opioid use. Antibiotic prophylaxis is recommended in penetrating (abdominal, thoracic) trauma, in severely burned and in open fractures elderly patients to decrease septic complications. Antibiotics are not recommended in blunt trauma in the absence of signs of sepsis and septic shock. Venous thromboembolism prophylaxis with LMWH or UFH should be administrated as soon as possible in high and moderate-risk elderly trauma patients according to the renal function, weight of the patient and bleeding risk. A palliative care team should be involved as soon as possible to discuss the end of life in a multidisciplinary approach considering the patient's directives, family feelings and representatives' desires, and all decisions should be shared. CONCLUSIONS: The management of elderly trauma patients requires knowledge of ageing physiology, a focused triage based on assessing frailty and early activation of trauma protocol to improve outcomes. Geriatric Intensive Care Units are needed to care for elderly and frail trauma patients in a multidisciplinary approach to decrease mortality and improve outcomes.

Antibiotic Prophylaxis for Hepato-Biliopancreatic Surgery-A Systematic Review.

BACKGROUND: Surgical site infections (SSIs) are among the most important determinants of morbidity after HBP surgery. Their frequency after HPB surgery is variable, from 1-2% after elective cholecystectomy to 25% after PD. METHODS: A systematic review was performed to assess the role of antimicrobial prophylaxis (AP) in HPB elective surgery. Articles published between 2015 and 2021 were obtained; those before 2015 were not included because they antedate the WHO guidelines on SSI prevention. We conducted three different research methods for liver resection, elective cholecystectomy and pancreatic and biliary surgery regarding patients requiring preoperative biliary drainage. RESULTS: Hepatic surgery, improvement in surgical technique and perioperative management lead to a very low SSI. One preoperative 2 g cefazolin dose may be adequate for surgical prophylaxis. From preoperative biliary drainage, we can derive that patients' homeostasis rather than AP plays a paramount role in reducing postoperative morbidity. The time from biliary drainage could be an essential element in decision making for surgical prophylaxis. In the case of low-risk cholecystectomy, it is not easy to draw definitive conclusions about the effect of AP. Data from the literature are inconsistent, and some risk factors cannot be predicted before surgery. CONCLUSION: in our opinion, a strict preoperative cefazolin dose strategy can be reasonable in HBP surgery until a large-scale, multicentric RCT brings definitive conclusions.

Immunohistochemical algorithms and gene expression profiling in primary cutaneous B-cell lymphoma.

OBJECTIVE: to assess whether immunohistochemical (IHC) algorithms used to classify the cell of origin (COO) of nodal Diffuse Large B-cell lymphoma (nDLBCL) in Germinal Center type (GCB) and non-GCB subtypes may be applied to Primary Cutaneous B-cell lymphoma (PCBCL) too, and which of these algorithms performs better on PCBCL. DESIGN: Retrospective case control study. SETTING: Pathology Department of the University Hospital "San Giovanni di Dio e Ruggi d'Aragona" Salerno, Italy. PARTICIPANTS: Fourteen PCBCL, including Primary Cutaneous follicle centre lymphoma (PCFCL) and primary cutaneous diffuse large B-cell lymphoma, Leg type (PCDLBCL-LT) and 14 nDLBCL were evaluated for 7-year period (January 2011 to December 2017). Primary cutaneous marginal zone cell lymphoma (PCMZL) cases were not included in the present study. INTERVENTION: Evaluation of immunohistochemical CD10, BCL6, MUM1/IRF4, BCL2, MYC and Ki-67 expression and classification according to three different algorithms. Gene expression profiling (GEP) was performed on the same series using Lymph2Cx assay (Nanostring). The data obtained were compared and analysed. RESULTS: All the IHC algorithms showed 13 GCB and 15 non-GCB. GEP showed 12 GCB, 12 activated B cell-type and 4 unclassified. CONCLUSIONS: The PCBCL were classifiable as GCB and non-GCB like the nDLBCL as IHC algorithms were concordant to GEP and produced the same results.

The WSES/SICG/ACOI/SICUT/AcEMC/SIFIPAC guidelines for diagnosis and treatment of acute left colonic diverticulitis in the elderly.

Acute left colonic diverticulitis (ALCD) in the elderly presents with unique epidemiological features when compared with younger patients. The clinical presentation is more nuanced in the elderly population, having higher in-hospital and postoperative mortality. Furthermore, geriatric comorbidities are a risk factor for complicated diverticulitis. Finally, elderly patients have a lower risk of recurrent episodes and, in case of recurrence, a lower probability of requiring urgent surgery than younger patients. The aim of the present work is to study age-related factors that may support a unique approach to the diagnosis and treatment of this problem in the elderly when compared with the WSES guidelines for the management of acute left-sided colonic diverticulitis. During the 1° Pisa Workshop of Acute Care & Trauma Surgery held in Pisa (Italy) in September 2019, with the collaboration of the World Society of Emergency Surgery (WSES), the Italian Society of Geriatric Surgery (SICG), the Italian Hospital Surgeons Association (ACOI), the Italian Emergency Surgery and Trauma Association (SICUT), the Academy of Emergency Medicine and Care (AcEMC) and the Italian Society of Surgical Pathophysiology (SIFIPAC), three panel members presented a number of statements developed for each of the four themes regarding the diagnosis and management of ALCD in older patients, formulated according to the GRADE approach, at a Consensus Conference where a panel of experts participated. The statements were subsequently debated, revised, and finally approved by the Consensus Conference attendees. The current paper is a summary report of the definitive guidelines statements on each of the following topics: diagnosis, management, surgical technique and antibiotic therapy.

Multidisciplinary management of elderly patients with rectal cancer: recommendations from the SICG (Italian Society of Geriatric Surgery), SIFIPAC (Italian Society of Surgical Pathophysiology), SICE (Italian Society of Endoscopic Surgery and new technologies), and the WSES (World Society of Emergency Surgery) International Consensus Project.

BACKGROUND AND AIMS: Although rectal cancer is predominantly a disease of older patients, current guidelines do not incorporate optimal treatment recommendations for the elderly and address only partially the associated specific challenges encountered in this population. This results in a wide variation and disparity in delivering a standard of care to this subset of patients. As the burden of rectal cancer in the elderly population continues to increase, it is crucial to assess whether current recommendations on treatment strategies for the general population can be adopted for the older adults, with the same beneficial oncological and functional outcomes. This multidisciplinary experts' consensus aims to refine current rectal cancer-specific guidelines for the elderly population in order to help to maximize rectal cancer therapeutic strategies while minimizing adverse impacts on functional outcomes and quality of life for these patients. METHODS: The discussion among the steering group of clinical experts and methodologists from the societies' expert panel involved clinicians practicing in general surgery, colorectal surgery, surgical oncology, geriatric oncology, geriatrics, gastroenterologists, radiologists, oncologists, radiation oncologists, and endoscopists. Research topics and questions were formulated, revised, and unanimously approved by all experts in two subsequent modified Delphi rounds in December 2020-January 2021. The steering committee was divided into nine teams following the main research field of members. Each conducted their literature search and drafted statements and recommendations on their research question. Literature search has been updated up to 2020 and statements and recommendations have been developed according to the GRADE methodology. A modified Delphi methodology was implemented to reach agreement among the experts on all statements and recommendations. CONCLUSIONS: The 2021 SICG-SIFIPAC-SICE-WSES consensus for the multidisciplinary management of elderly patients with rectal cancer aims to provide updated evidence-based statements and recommendations on each of the following topics: epidemiology, pre-intervention strategies, diagnosis and staging, neoadjuvant chemoradiation, surgery, watch and wait strategy, adjuvant chemotherapy, synchronous liver metastases, and emergency presentation of rectal cancer.

Acute cholecystitis during COVID-19 pandemic: a multisocietary position statement.

Following the spread of the infection from the new SARS-CoV2 coronavirus in March 2020, several surgical societies have released their recommendations to manage the implications of the COVID-19 pandemic for the daily clinical practice. The recommendations on emergency surgery have fueled a debate among surgeons on an international level.We maintain that laparoscopic cholecystectomy remains the treatment of choice for acute cholecystitis, even in the COVID-19 era. Moreover, since laparoscopic cholecystectomy is not more likely to spread the COVID-19 infection than open cholecystectomy, it must be organized in such a way as to be carried out safely even in the present situation, to guarantee the patient with the best outcomes that minimally invasive surgery has shown to have.

Surgery in COVID-19 patients: operational directives.

The current COVID-19 pandemic underlines the importance of a mindful utilization of financial and human resources. Preserving resources and manpower is paramount in healthcare. It is important to ensure the ability of surgeons and specialized professionals to function through the pandemic. A conscious effort should be made to minimize infection in this sector. A high mortality rate within this group would be detrimental.This manuscript is the result of a collaboration between the major Italian surgical and anesthesiologic societies: ACOI, SIC, SICUT, SICO, SICG, SIFIPAC, SICE, and SIAARTI. We aim to describe recommended clinical pathways for COVID-19-positive patients requiring acute non-deferrable surgical care. All hospitals should organize dedicated protocols and workforce training as part of the effort to face the current pandemic.

The SIFIPAC/WSES/SICG/SIMEU guidelines for diagnosis and treatment of acute appendicitis in the elderly (2019 edition).

The epidemiology and the outcomes of acute appendicitis in elderly patients are very different from the younger population. Elderly patients with acute appendicitis showed higher mortality, higher perforation rate, lower diagnostic accuracy, longer delay from symptoms onset and admission, higher postoperative complication rate and higher risk of colonic and appendiceal cancer. The aim of the present work was to investigate age-related factors that could influence a different approach, compared to the 2016 WSES Jerusalem guidelines on general population, in terms of diagnosis and management of elderly patient with acute appendicitis. During the XXIX National Congress of the Italian Society of Surgical Pathophysiology (SIFIPAC) held in Cesena (Italy) in May 2019, in collaboration with the Italian Society of Geriatric Surgery (SICG), the World Society of Emergency Surgery (WSES) and the Italian Society of Emergency Medicine (SIMEU), a panel of experts participated to a Consensus Conference where eight panelists presented a number of statements, which were developed for each of the four topics about diagnosis and management of acute appendicitis in elderly patients, formulated according to the GRADE system. The statements were then voted, eventually modified and finally approved by the participants to the Consensus Conference. The current paper is reporting the definitive guidelines statements on each of the following topics: diagnosis, non-operative management, operative management and antibiotic therapy.

2017 WSES and SICG guidelines on acute calcolous cholecystitis in elderly population.

BACKGROUND: Gallstone disease is very common afflicting 20 million people in the USA. In Europe, the overall incidence of gallstone disease is 18.8% in women and 9.5% in men. The frequency of gallstones related disease increases by age. The elderly population is increasing worldwide. AIM: The present guidelines aims to report the results of the World Society of Emergency Surgery (WSES) and Italian Surgical Society for Elderly (SICG) consensus conference on acute calcolous cholecystitis (ACC) focused on elderly population. MATERIAL AND METHODS: The 2016 WSES guidelines on ACC were used as baseline; six questions have been used to investigate the particularities in elderly population; the answers have been developed in terms of differences compared to the general population and to statements of the 2016 WSES Guidelines. The Consensus Conference discusses, voted, and modified the statements. International experts contributed in the elaboration of final statements and evaluation of the level of scientific evidences. RESULTS: The quality of the studies available decreases when we approach ACC in elderly. Same admission laparoscopic cholecystectomy should be suggested for elderly people with ACC; frailty scores as well as clinical and surgical risk scores could be adopted but no general consensus exist. The role of cholecystostomy is uncertain. DISCUSSION AND CONCLUSIONS: The evaluation of pro and cons for surgery or for alternative treatments in elderly suffering of ACC is more complex than in young people; also, the oldest old age is not a contraindication for surgery; however, a larger use of frailty and surgical risk scores could contribute to reach the best clinical judgment by the surgeon. The present guidelines offer the opportunity to share with the scientific community a baseline for future researches and discussion.

Gastric cancer surgery: clinical outcomes and prognosis are influenced by perioperative blood transfusions.

Gastric cancer in patients is often associated with bleeding; when it occurs, especially in the presence of an anemia, a transfusion is necessary to avoid further deterioration of the patient's clinical state. The aim of this study was to evaluate the relationship between the administration of peri-operative transfusions due to the anemia or the clinical status and the post-operative clinical outcomes. 188 patients diagnosed with of gastric cancer were recruited at Surgery 2 of the Department of General and Specialist Surgery of the Tertiary Care Hospital "A. Cardarelli" of Naples. All patients had a total or a subtotal gastrectomy accompanied by D2 lymphectomy for gastric cancer. The clinical data most frequently associated with blood transfusion is the appearance of a post-operative infection (OR 2.26, 95% CI 0.87-5.79, P = 0.061). If the administration time of transfusion is considered, the clinical outcomes are different: preoperative transfusions showed a higher incidence of infections (OR 2.26, 95% CI 0.87-5.79, P = 0.061) and acute renal failure (OR 2.82, 95% CI 0.70-10.78, P = 0.078); patients who received intra or post-operative transfusions showed a prolonged hospitalization (OR 8.66, 95% CI 1.73-83.00, P = 0.002). The administration of blood products in the perioperative period is correlated in a statistically significant manner to the incidence of infections, acute renal failure and prolonged hospitalization; therefore, transfusions should be avoided unless clinically necessary and in particular intraoperative transfusions should be avoided because the immunomodulation effect linked to surgical stress may be enhanced hence worsening the prognosis.

Human exposure to bisphenol AF and diethylhexylphthalate increases susceptibility to develop differentiated thyroid cancer in patients with thyroid nodules.

Pollutants represent potential threats to the human health, being ubiquitous in the environment and exerting toxicity even at low doses. This study aims at investigating the role of fifteen multiclass organic pollutants, assumed as markers of environmental pollution, most of which exerting endocrine-disrupting activity, in thyroid cancer development. The increasing incidence of differentiated thyroid cancer (DTC) may be related to the rising production and environmental dissemination of pollutants. Fifty-five patients, twenty-seven with diagnosis of benign thyroid nodules and twenty-eight suffering from differentiated thyroid cancer, were enrolled and the concentration levels of seven bisphenols, two phthalates (i.e. di(2-ethylhexyl) phthalate (DEHP) and its main metabolite, mono-(2-ethyl-hexyl) phthalate) (MEHP)), two chlorobenzenes, (1,4-dichlorobenzene and 1,2,4,5-tetrachlorobenzene), and 3 phenol derivatives (2-chlorophenol, 4- nonylphenol, and triclosan) were determined in their serum by using a validated analytical method based on high performance liquid chromatography with ultraviolet tandem fluorescence detection. A significant relationship was found between malignancy and the detection in the serum of both bisphenol AF and DEHP. Indeed, their presence confers a more than fourteen times higher risk of developing differentiated thyroid cancer. Relationship between these two pollutants and the risk of malignancy was dose-independent and not mediated by higher thyroid stimulating hormone levels. Even if a conclusive evidence cannot still be drawn and larger prospective studies are needed, the exposure to low doses of environmental endocrine-disrupting contaminants can be considered consistent with the development of thyroid cancer.

Preoperative ultrasound evaluation of laterocervical lymph nodes: timing and experience modify the treatment of patients with differentiated thyroid cancer.

Since laterocervical lymphadenectomy is never routinely performed, all patients who undergo thyroidectomy for differentiated cancer must have an ultrasound examination (US). The aim of this study is to assess the accuracy of the preoperative US conducted at the time of surgery as a staging US (time 0) compared to the US performed sometime before in a location other than the surgical department as screening/diagnostic US (time - 1), to determine the necessity of always performing a preoperative US before surgery. 4060 patients with cytologic diagnosis (FNAB) of differentiated thyroid neoplasm (Tyr 4 and Tyr 5) were recruited at Surgery 2 of the Department of General and Specialist Surgery of the Tertiary Care Hospital "A. Cardarelli" of Naples. All patients had a screening US prior to admission into our hospital (time - 1) and were rescanned in the operating room before surgery (time 0) by the same team of surgeons experienced in the field of thyroid diseases. The examinations conducted at time 0 revealed a sensitivity of 100% and a specificity of 92.3%, while examinations performed at time - 1 showed a sensitivity of 22.8% and a specificity of 72.7%. The statistical analysis shows how the diagnostic timing and the experience of the examiner can make a difference both in terms of PPV and NPV to not only to assist in identifying all the lymph node lesions that would remain indeterminate if not specifically researched during surgery, but also helps avoid surgical overtreatment. The systematic execution of a staging US (time 0) in addition to a screening/diagnostic US (time - 1) results in forming a more appropriate therapeutic plan.

The culture of gut explants: A model to study the mucosal response.

Various experimental model designs have been used to analyze the inflammatory pathways in human gastrointestinal illnesses. Traditionally, analytical techniques and animal models are popular experimental tools to study the inflammation process of intestinal diseases. However, the comparison of results between animal and human models is difficult for the inconsistency of outcomes. Although there are different animal models for studying the intestinal diseases, none of them fully represents the physiological and environmental conditions typical of the human species. Also, there is currently a concerted effort to decrease the experimental use of animals. On the converse, experimental protocols using the culture of gut mucosa had become popular with the advent of endoscopy which allows explanting multiple fragments from the intestine. The peculiar characteristic of this model is the ability to preserve in vitro the features that we found in vivo, thus also the response to various stimuli that differs from person to person. The aim of the present paper is to provide a review of some of the possible uses of the organ intestinal mucosa culture.

Post-thyroidectomy complications. The role of the device: bipolar vs ultrasonic device: Collection of data from 1,846 consecutive patients undergoing thyroidectomy.

BACKGROUND: Specific complications after thyroid surgery, such as recurrent laryngeal nerve injury (RLN) or hypoparathyroidism, are feared because they may give rise to a lifelong disability for the patient. The aim of this study was to evaluate the possible association between the types of device used (bipolar vs ultrasound-based harmonic scalpel defined Harmonic Focus) and major postoperative complications. METHODS: During a 1-year period, between October 2010 and October 2011, Italian Endocrine Surgery Units affiliated with the Italian Endocrine Surgery Units Association collected data on all consecutive patients older than 18 years who had undergone primary total thyroidectomy, near total thyroidectomy, and completion thyroidectomy. The data were included in a dataset, listing demographic variables, details on the surgical procedure, and 2 major complications of the thyroid surgery: postoperative RLN palsy/hypomobility and hypocalcemia. RESULTS: Our population comprised 1,846 subjects (78.6% women, median age 52 years). Six hundred four (32.7%) subjects underwent thyroidectomy by bipolar forceps and 1,242 (67.3%) by ultrasonic device. The risk of hypocalcemia in subjects undergoing thyroidectomy by ultrasonic device was similar to those undergoing thyroidectomy by bipolar after adjusting for sex, type of thyroidectomy, and central lymphadenectomy (odds ratio .94, 95% confidence interval .76 to 1.17). Subjects who underwent thyroidectomy by ultrasonic device had a lower risk of RLN paralysis compared with those undergoing thyroidectomy by bipolar forceps also after adjusting for central lymphadenectomy (odds ratio .39, 95% confidence interval .2 to .7). CONCLUSION: This multicenter study acknowledges the value of the ultrasonic device as a protective factor only for RLN palsy, confirming nodal dissection as a risk factor for postoperative hypocalcemia and vocal folds disorders.

Benign thyroid nodules with RAS mutation grow faster.

CONTEXT: The management of a benign thyroid nodule includes follow-up until its size requires a surgical or alternative treatment. To date, it is difficult or impossible to predict the size changes of a benign nodule in a given patient because no specific growth parameters exist. RAS mutations have been described in thyroid adenomas and hyperplastic benign nodules. OBJECTIVE: The aim of this study was to establish whether the volume changes of benign nodules are associated with the presence of RAS mutation. PATIENTS AND METHODS: Genomic DNA obtained by fine-needle aspiration of 78 thyroid nodules with benign cytology was analysed by pyrosequencing for the presence of NRAS(61) and KRAS(13) mutations. Ultrasonographic features were obtained. The volume of nodules at baseline and their changes after a mean follow-up of 25 months were evaluated according to the presence of RAS mutation. RESULTS: A RAS mutation was found in 24 thyroid aspirates (30·8%, 8 NRAS(61) and 16 KRAS(13) ). RAS mutation was not associated with ultrasonographic features, but was significantly associated with a larger size at baseline (P = 0·017). After a 25-month mean follow-up, RAS mutation-positive nodules displayed faster growth (RAS mutation-positive vs RAS mutation-negative % annual growth 27·6% ±32·2% vs 1·0% ±17·0%, P < 0·001). CONCLUSIONS: Benign thyroid nodules bearing RAS mutation grow more rapidly than those with wild-type RAS. Searching for RAS mutations in thyroid nodules with benign cytology might be useful to the clinician in choosing a more appropriate and timely surgical management.

Pituitary dysfunction and its association with quality of life in traumatic brain injury.

BACKGROUND: Traumatic brain injury (TBI) is a major cause of death and disability and may cause transient or persistent, isolated or multiple hypopituitarism in a variable percentage of cases. OBJECTIVES: The primary aim of this study was to determine the incidence of isolated and multiple anterior pituitary hormone deficiency in subjects with TBI in a single institution. The secondary aim was to determine a correlation between pituitary deficiency and quality of life (QOL) after TBI. METHODS: Thirty-five patients, aged between 18 and 63 years, were evaluated 6months to 5 years after TBI. We evaluated the QOL by SF-12(®) questionnaire and measured serum basal GH, IGF1, LH, FSH, testosterone (in males), 17-ß-estradiol (in women), PRL, fT4 and TSH. In patients with low IGF1, a GHRH + Arginine test was performed. RESULTS: Single or multiple pituitary failure was found in 13 patients (37%). Low testosterone was found in 7 males, low FSH and/or LH in 4, low IGF1 in 7 patients. Hypogonadotropic hypogonadism and GH insufficiency assessed by GHRH + Arginine test were found respectively in 3 and 2 patients. One patient displayed a concomitant GH insufficiency and low TSH level. Twenty six patients showed a reduction in QOL. A correlations between altered QOL and hormonal deficiency was not observed. CONCLUSIONS: Isolated or multiple hypopituitarism resulting from TBI are frequent. Alterations in QOL and pituitary function resulting from TBI are not associated.

Hypocalcaemia after total thyroidectomy: could intact parathyroid hormone be a predictive factor for transient postoperative hypocalcemia?

BACKGROUND: Hypocalcemia, the most common complication of thyroidectomy, is a transient condition in up to 27% of patients and a permanent condition approximately 1% of patients. The aim of this prospective study was to evaluate reliability of postoperative intact parathyroid hormone (iPTH) assessment for predicting clinically relevant postthyroidectomy hypocalcemia for a safe early discharge of patients with no overtreatment. METHODS: Seventy-five consecutive patients (age 51 ± 13 years [mean ± SD]) undergoing total or completion thyroidectomy with no concomitant parathyroid diseases or renal failure were included in the present study. Serum iPTH level was determined before and 2 hours after thyroidectomy. Serum calcium concentration was determined 1 day before and 2 days postoperatively. RESULTS: The occurrence of postoperative hypocalcemia was correlated both with the absolute and relative iPTH decrease, determined as a ratio of the preoperative value (P < .0001). There was a greater difference in relative decrease in iPTH between patients remaining normocalcemic and those with hypocalcemia present on the second postoperative day. Hypocalcemic patients on the second postoperative day had a 62% relative decrease in iPTH 2 hours after thyroidectomy. CONCLUSION: The relative decrease in serum iPTH was greater in patients with hypocalcemia arising on the second postoperative day rather than in patients who remained normocalcemic. The relative decrease in iPTH determined 2 hours after total thyroidectomy together with the serum calcium concentration 24 hours after thyroidectomy proved to be useful predictors of sustained hypocalcemia and might change the clinical management of patients after thyroid surgery to support a longer hospitalization in these selected patients.

Very low-carbohydrate ketogenic diet before bariatric surgery: prospective evaluation of a sequential diet.

BACKGROUND: We evaluated the effectiveness of a sequential diet regimen termed the obese preoperative diet (OPOD) in morbidly obese patients with and without type 2 diabetes mellitus (T2DM) scheduled for laparoscopic bariatric surgery. METHODS: Fifty patients (body mass index 53.5 ± 8.4 kg/m(2)) scheduled for bariatric surgery, including 14 with T2DM, were prospectively enrolled and followed the OPOD regimen: a very low-calorie ketogenic diet for 10 days, followed by a very low-calorie diet for 10 days, and then a low-calorie diet for 10 days. Patients were evaluated at baseline (T0) and after 10 days (T1), 20 days (T2), and 30 days (T3). RESULTS: Body weight, body mass index, waist circumference, and neck circumference were significantly lower at T1, T2, and T3 than at T0 in the 48 patients who completed the OPOD. Two patients discontinued the OPOD after 4-7 days. In patients with T2DM, fasting plasma glucose levels decreased significantly, enabling reduction of diabetic medications. Plasma and urine ketone levels increased at T1 but were all <1 mmol/L, and hunger decreased during the diet period. CONCLUSIONS: OPOD, including 10 days of a VLCKD, was safe and effective in morbidly obese patients, and it seems to be promising in morbidly obese patients with and without T2DM scheduled for laparoscopic bariatric surgery.