Readmission and reoperation rates after laparoscopic bariatric surgery in an Italian center of excellence.

BACKGROUND: The aim of this study was to analyze short-term outcomes focusing on readmissions after laparoscopic bariatric metabolic surgery (BMS) in an Italian academic Bariatric Center of Excellence IFSO-European Chapter (EC). METHODS: This is a retrospective study based on the analysis of a prospectively maintained institutional database. Patients aged between 18 and 65 years who underwent primary BMS and/or revisional BMS (RBMS) between 2012 and 2021 were included. Primary endpoint was to analyze the readmission rate at 30 postoperative days. The secondary endpoint involved assessing the causes of readmission within 30 days of discharge, the rates, and types of reoperations and/or additional procedures related to the first surgery, and the outcomes of readmitted patients. RESULTS: A total of 2297 patients were included in the study. Among them, 2143 underwent primary surgery and 154 patients underwent RBMS. Eighty-two percent of the Enhanced Recovery after Surgery (ERAS) protocol items were applied starting from 2016. Within 30 days after discharge, 48 patients (2.09%) were readmitted. Overall readmission rate following primary and revisional BMS was 2.15%, respectively 1.30%. Ten readmitted patients (20.8%) had complications graded IIIb or more (Clavien-Dindo classification) and needed additional procedures. Mortality rate was 4.17% among readmitted patients. CONCLUSIONS: Only 2.09% of patients undergoing laparoscopic bariatric surgery were readmitted. Of these, 20.8% required additional procedures. Standardization of surgical techniques and perioperative protocols in a bariatric center of excellence resulted in a low readmission rate even in RBMS.

Trends and safety of bariatric revisional surgery in Italy: multicenter, prospective, observational study.

BACKGROUND: Revisional bariatric surgery (RBS) represents a further solution for patients who experience inadequate weight loss (IWL) following primary bariatric surgery (BS) or significant weight regain (WR) following initial satisfactory response. RBS guidelines are lacking; however, an increased trend in further BS offerings has been reported recently. OBJECTIVE: Analyze trend, mortality, complication, readmission, and reoperation rates for any reason at 30 days after RBS in Italy. SETTING: Ten Italian high-volume BS centers (university hospitals and private centers). METHODS: Prospective, observational, multicenter study enrolling patients undergoing RBS between October 1, 2021, and March 31, 2022, registering reasons for RBS, technique, mortality, intraoperative and perioperative complications, readmissions, and reinterventions for any reason. Patients undergoing RBS during the same calendar interval in 2016-2020 were considered control patients. RESULTS: A total of 220 patients were enrolled and compared with 560 control-group patients. Mortality was .45% versus .35% (n.s), with an overall mortality of .25%, while open surgery or conversion to open surgery was registered in 1%. No difference was found for mortality, morbidity, complications, readmission (1.3%), and reoperation rates (2.2%). IWL/WR was the most frequent cause, followed by gastroesophageal reflux disease; Roux-en-Y gastric bypass was the most used revisional procedure (56%). Sleeve gastrectomy was the most revised procedure in the study group, while gastric banding was the most revised in the control group. RBS represents up to 9% of the total BS in the Italian participating centers. CONCLUSIONS: Laparoscopy represents the standard approach for RBS, which appears safe. Current Italian trends show a shift toward sleeve gastrectomy being the most revised procedure and Roux-en-Y gastric bypass being the most frequent revisional procedure.

Platelet-rich plasma PRP vs. absorbable mesh as cruroplasty reinforcement: a study on an animal model.

BACKGROUND: Reinforcement of posterior cruroplasty has been proposed to minimize the failure of hiatal hernia repair (HHR). The applications of autologous platelet-rich plasma (PRP) and absorbable mesh are barely reported in this area. AIMS: To analyze local macroscopic and microscopic changes induced by mesh vs. PRP as reinforcement of HHR, using a reliable laparoscopic experimental porcine model. MATERIAL AND METHODS: This prospective, comparative pilot study was conducted on 14 female pigs, aged four to six months. An iatrogenic hiatal defect was laparoscopically simulated and repaired, reinforced with Bio-A® mesh (group A) or PRP (group B). Specimen retrieval was performed after seven months for histopathological (HP) examination. RESULTS: No local or general complications were registered, with complete resorption of reinforcements, that determined inflammatory infiltrates with local collagen production and tissue neo-vascularization. Group A had an increased mean chronic inflammation score (p = .3061), showing significant sclerotic collagenizing process. PRP enhanced angiogenesis, collagenizing, myofibroblast recruitment and tissue ingrowth. CONCLUSIONS: No residual materials or evidence of anatomical distortion were found. Animal model was safe and reliable. This is the first report of complete absorption of Bio-A® positioned on crural area. HP results suggest the clinical application of PRP in HHR as a promising co-adjuvant to local remodeling and healing.Abbreviations: ASA: American Society of Anesthesiologists; AB: Alcian Blue; PAS: Periodic Acid-Schiff; CP: platelet concentrate; fPC: filtered plasma concentrate; GERD: gastro-esophageal reflux disease; HSA: hiatal surface area; HHR: hiatal hernia repair; HP: histopathological; HH: hiatal hernia; HE: hematoxylin and eosin; HR: hiatus repair alone; HRM: hiatus repair and acellular dermal matrix; NM: Nicolae Manolesccu; LNF: laparoscopic Nissen fundoplication; PC: posterior cruroplasty; PPP: platelet-poor plasma; RP: platelet-rich plasma.

Preoperative measurement of the hiatal surface with MDCT: impact on surgical planning.

OBJECTIVE: To evaluate the accuracy and reproducibility of hiatal surface area (HSA) measurement on dedicated multidetector computed tomography (MDCT) acquisition, in patients, previously subjected to laparoscopic sleeve gastrectomy (LSG), and affected by gastroesophageal reflux disease (GERD). Intraoperative HSA measurement was considered the reference standard. METHODS: Fifty-two candidates for laparoscopic hiatal hernia repair were prospectively included in the study. MDCT images were acquired during swallowing of oral iodinated contrast media and during strain. Measurements were performed by nine readers divided into three groups according to their experience. Results were compared with intraoperative measurements by means of Spearman correlation coefficient. Reproducibility was evaluated with intra- and interreader agreement by means of weighted Cohen's kappa and intraclass correlation coefficient (ICC). RESULTS: Significant differences between MDCT and intraoperative HSA measurements were observed for swallowing imaging for less experienced readers (p = 0.037, 0.025, 0.028 and 0.019). No other statistically significant differences were observed (p > 0.05). The correlation between HSA measured intraoperatively and on MDCT was higher for strain imaging compared to swallowing (r = 0.94-0.92 vs 0.94-0.89). The overall reproducibility of MDCT HSA measurement was excellent (ICC of 0.95; 95% CI 0,8993 to 0,9840) independently of reader's experience CONCLUSION: HSA can be accurately measured on MDCT images. This method is reproducible and minimally influenced by reader experience. The preoperative measurement of HSA has potential advantages for surgeons in terms of correct approach to hiatal defects in obese patient.

Laparoscopic bariatric surgery is safe during phase 2-3 of COVID-19 pandemic in Italy: A multicenter, prospective, observational study.

BACKGROUND: Sars-Cov-2 epidemic in Italy caused one of the greatest 2020 European outbreaks, with suspension of elective bariatric/metabolic surgery (BMS). From May 2020 a significant decline of the epidemic has been observed (phase 2); National Health Service protocols permitted elective BMS' resumption. A new, more severe COVID-19 surge, the "second wave", started on October 2020 (phase 3). AIM: The primary end point was to analyze the outcomes of any Sars-Cov-2 infection and related morbidity/mortality within 30 POD after laparoscopic BMS during phase 2-3; secondary end points were readmission and reoperation rates. METHODS: Study design prospective, multicenter, observational. SETTING: Eight Italian high-volume bariatric centers. All patients undergoing BMS from July 2020 through January 2021 were enrolled according to the following criteria: no Sars-Cov-2 infection; primary procedures; no concomitant procedure; age > 18 < 60 years; compensated comorbidities; informed consent including COVID-19 addendum; adherence to specific admission, in-hospital and follow-up protocols. Data were collected in a prospective database. Patients undergone BMS during July-December 2019 were considered a control group. RESULTS: 1258 patients were enrolled and compared with 1451 operated on in 2019, with no differences for demographics, complications, readmission, and reintervention rates. Eight patients (0·6%) tested positive for Sars-Cov-2 infection after discharge, as well as and 15 healthcare professionals, with no related complications or mortality. CONCLUSIONS: Introduction of strict COVID-19 protocols concerning the protection of patients and health-care professionals guaranteed a safe resumption of elective BMS in Italy. The safety profile was, also, maintained during the second wave of outbreak, thus allowing access to a cure for the obese population.

Telematics pre-operative psychological and nutritional assessment in candidates for bariatric surgery during COVID-19 phase 2: a pilot prospective observational study.

BACKGROUND: Obesity represents a risk factor for COVID-19 infection. Therefore, in order to reduce COVID-19 related comorbidities in obese population a continuation of obesity treatment is needed. However, bariatric procedures were postponed because of COVID-19 restrictions, delaying treatment for obese patients seeking for surgery. This study aimed to test the feasibility of a telematics pre-operative psychological and nutritional assessment as an alternative tool during COVID-19 outbreak. METHODS: Twenty-six patients were contacted. The pre-operative assessment consisted in 3-weekly one-to-one online sessions and a final in-person multidisciplinary session. The protocol feasibility has been evaluated on the following outcome: rejection rate (%), dropout rate (%), compliance and satisfaction's degree. RESULTS: Eighteen participants completed the whole protocol and 10% dropped-out. Seventy-two percent of participants obtained an excess weight loss ≥5%. All participants were satisfied of the telematics assessment. CONCLUSIONS: COVID-19 emergency has changed standard hospital procedures and this study could represent a landmark for an online pre-operative assessment method to adopt in case of new restrictions.

Hiatal Surface Area's CT scan measurement is useful in hiatal hernia's treatment of bariatric patients.

INTRODUCTION: Hiatal surface area (HSA) measurement has been recently proposed as useful tool for tailored treatment of hiatal defects. Multidetector CT scan (MDCT) of the hiatal area was shown to be useful in hiatal hernia (HH) management. PURPOSE: MDCT preoperative HSA measurements validation as a useful method in the surgical repair decision making process of hiatal defects in candidates to antireflux ± bariatric surgery. MATERIAL AND METHODS: Twenty-five obese patients (group A), candidates to laparoscopic cruroplasty ± bariatric surgery, were prospectively evaluated preoperatively and after one year, using an original MDCT algorithm, compared with intraoperative HSA measurement. Twelve non-obese (group B) and 12 obese patients (group C), without GERD or HH, were used as control groups. RESULTS: Median preoperative HSA was 7.9 cm2, (interquartile IQR 5.97-9.80) while intraoperative median HSA was 6 cm2 (6-9.5), p = .84. Postoperative median HSA was 3.8 cm2 (3.21-4.8), showing the efficacy of cruroplasty, comparable with HSA calculated in the control groups (3.98 for B and 3.69 cm2 for C, p = .8547). No statistically significant difference between MDCT preoperative measurement and intraoperative findings was observed. CONCLUSIONS: Preliminary results demonstrate MDCT scan HSA measurements as a valid, non-invasive method to predict intraoperative findings. It allows the HSA monitoring in order to correlate the symptoms onset and failure of cruroplasty.

Concomitant hiatal hernia repair during bariatric surgery: does the reinforcement make the difference?

BACKGROUND: Hiatal hernia repair (HHR) is still controversial during bariatric procedures, especially in case of laparoscopic sleeve gastrectomy (LSG). AIMS: to report the long-term results of concomitant HHR, evaluating the safety and efficacy of posterior cruroplasty (PC), simple or reinforced with biosynthetic, absorbable Bio-A® mesh (Gore, Flagstaff, AZ, USA). Primary endpoint: PC's failure, defined as symptomatic HH recurrence, nonresponding to medical treatment and requiring revisional surgery. METHODS: The prospective database of 1876 bariatric operations performed in a center of excellence between 2011-2019 was searched for concomitant HHR. Intraoperative measurement of the hiatal surface area (HSA) was performed routinely. RESULTS: A total of 250 patients undergone bariatric surgery and concomitant HHR (13%). Simple PC (group A, 151 patients) was performed during 130 LSG, 5 re-sleeves and 16 gastric bypasses; mean BMI 43.4±5.8 kg/m2, HSA mean size 3.4±2 cm2. Reinforced PC (group B) was performed in 99 cases: 62 primary LSG, 22 LGB and 15 revisions of LSG; mean BMI 44.6±7.7 kg/m2, HSA mean size 6.7±2 cm2. PC's failure, with intrathoracic migration (ITM) of the LSG was encountered in 12 cases (8%) of simple vs. only 4 cases (4%) of reinforced PC (P=0.23); hence, a repeat, reinforced PC and R-en-Y gastric bypass (LRYGB) was performed laparoscopically in all cases. No mesh-related complications were registered perioperatively or after long-term follow-up (mean 50 months). One case of cardiac metaplasia without goblet cells was detected 4 years postoperatively; conversion to LRYGB, with reinforced redo of the PC was performed. The Cox hazard analysis showed that the use of more than four stitches for cruroplasty represents a negative factor on recurrence (HR=8; P<0.05). CONCLUSIONS: An aggressive search for and repair of HH during any bariatric procedure seems advisable, allowing a low HH recurrence rates. Additional measures, like mesh reinforcement of crural closure with biosynthetic, absorbable mesh, seem to improve results on long term follow-up, especially in case of larger hiatal defects. In our experience, reinforcement of even smaller defects seems advisable in obese population.

The impact of the surgical technique on stenosis after laparoscopic sleeve gastrectomy.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has gained worldwide popularity in the last 10 years as self alone bariatric procedure. Symptomatic stenosis (SS) is a potential severe postoperative complication and it can be divided in organic stenosis (OS) and functional stenosis (FS). The aim of this paper is to propose a modified surgical technique to prevent FS. METHODS: A retrospective review on 5235 LSG performed in Ponderas Academic Hospital between January 2011 and December 2019, searched FS in two consecutive patients groups, divided based on the modified surgical technique introduced in 2015, with fixation of the gastric tube to the prepancreatic fascia and stapler line's over-sewn running suture. RESULTS: Group A (2011-2014) included 1332 LSG, 16 SS were registered (1.2%), 7 OS and 9 FS; 3903 LSG included in group B (2015-2019), counting for 37 SS (0.95%), 27 OS and 10 FS. A statistically significant difference between the 2 groups was observed for the FS incidence (P=0.03), while it was non-significant for the OS (P=0.52) and the total number of SS (P=0.43). The endoscopic approach was used in forty-eight SS (90.5%) with a successful rate of 83%, while specifically for the FS it was 100%; only one complication was registered during endoscopic treatment, that required further surgical solution. CONCLUSIONS: Fixation of the gastric tube to the prepancreatic fascia and stapler line's over-sewn running suture during LSG, introduced lately, are beneficial in preventing the postoperative functional stenosis of the LSG, contributing to the improvement of the patient's quality of life.

Persistent Fistula after Sleeve Gastrectomy: A Chronic Dilemma.

Background: There is no time limit for the occurrence of leaks after sleeve gastrectomy LSG, and very late ones might evolve versus persistent, chronic fistulas. The aim of this retrospective study was to analyze the incidence, treatment and outcomes of persistent, chronic fistulas occurred or treated in a bariatric Center of Excellence IFSO-EC (CoE) and to establish a standardized approach. Materials Methods: between 2011-2018, nine cases of postoperative leaks occurred on a total of 1365 LSG performed (0.65%), 7 of them having late presentations (onset over 10 days postoperative). Chronic, persistent fistulas were identified and analyzed, including one gastro-bronchial and one gastro-cutaneous fistulas. Results: We present three peculiar cases of very late, chronic type III fistulas, with onset at 6-84 months after primary LSG and their management, including conservative, interventional radiology and endoscopy and surgical therapies. Conclusions: the management of late, chronic type III fistula is variable, with no standard algorithm to follow, but it should be planned based on the clinical evaluation, time of diagnosis, available resources, multidisciplinary approach and expertise. This emphasises again the necessity of a bariatric CoE that can guarantee a better diagnose and treatment, based on the use of wide, available resources, both professional and material.

A case of pancreatic cancer with concomitant median arcuate ligament syndrome treated successfully using an allograft arterial transposition.

An association of pancreatic cancer and median arcuate ligament syndrome (MALS) is a rare and challenging situation in terms of treatment. A 60-year-old man diagnosed with pancreatic cancer underwent laparotomy. A pancreaticoduodenectomy was planned, but during the resection part of the operation, a celiac artery stenosis was noticed. The patient was diagnosed with MALS causing almost total celiac artery occlusion, with no radiological solution. The patient was re-operated the next day, and an iliac artery allograft was used for aorta-proper hepatic artery reconstruction, concomitant with the total pancreaticoduodenectomy. Preoperative meticulous evaluation of vascular structures of the celiac trunk and its branches is important, especially in pancreatic surgery. A vascular allograft may be a lifesaving alternative when vascular reconstruction is necessary.

Acute complications after laparoscopic bariatric procedures: update for the general surgeon.

BACKGROUND: Development and widespread use of laparoscopic bariatric surgery exposes emergency room physicians and general surgeons to face acute or chronic surgical complications of bariatric surgery. METHODS: The most common surgical emergencies after bariatric surgery are examined based on an extensive review of bariatric surgery literature and on the personal experience of the authors' practice in four high-volume bariatric surgery centers. RESULTS: An orderly stepwise approach to the bariatric patient with an emergency condition is advisable. Resuscitation should follow the same protocol adopted for the non-bariatric patients. Consultation with the bariatric surgeon should be obtained early, and referral to the bariatric center should be considered whenever possible. The identification of the surgical procedure to which the patient was submitted will orient in the diagnosis of the acute condition. Procedure-specific complication should always be taken into consideration in the differential diagnosis. Acute slippage is the most frequent complication that needs emergency treatment in a laparoscopic gastric banding. Sleeve gastrectomy and gastric bypasses may present with life-threatening suture leaks or suture line bleeding. Gastric greater curvature plication (investigational restrictive procedure) can present early complications related to prolonged postoperative vomiting. Both gastric bypass and bilio-pancreatic diversion may cause anastomotic marginal ulcer, bleeding, or rarely perforation and severe stenosis, while small bowel obstruction due to internal hernia represents a surgical emergency, also caused by trocar site hernia, intussusceptions, adhesions, strictures, kinking, or blood clots. Rapid weight loss after bariatric surgery can cause cholecystitis or choledocholithiasis, which are difficult to treat after bypass procedures. CONCLUSIONS: The general surgeon should be informed about modern bariatric procedures, their potential acute complications, and emergency management.