Efficacy and safety of Propionibacterium extract gel versus glyceryl trinitrate ointment in the treatment of chronic anal fissure: a randomized controlled trial.

AIM: Chronic anal fissure (CAF) is an extremely frequent finding in clinical practice. Several topical agents have been proposed for its treatment with the common goal of increasing anodermal blood flow to promote healing. The aim of this study was to compare the efficacy and safety of a Propionibacterium extract gel (PeG) and 0.4% glyceryl trinitrate ointment (GTN) in patients with CAF. METHOD: Patients were randomly allocated to a PeG or GTN group and medication was administered every 12 h for 40 days. The primary outcome was the success rate, as measured by a decrease in the REALISE scoring system for anal fissure at 10, 20 and 40 days after initiating either treatment. The secondary outcomes recorded at the same time points were healing rate, visual analogue scales for itching and burning, rate of complications and adverse events, patient quality of life and satisfaction, and cost analysis. RESULTS: A total of 120 patients were enrolled, and 96 patients (PeG, n = 53; GTN, n = 43) completed the primary outcomes. A significant decrease over time in the REALISE score was observed in both groups. Adverse events occurred more frequently in the GTN group than in the PeG group, peaking at visit 1 [37 (63.8%) vs. 2 (3.4%), respectively], with headache being the most prevalent. The between-treatment cumulative average costs per patient were significantly higher for GTN than that for PeG at each follow-up visit. There were no other significant differences between the two groups for any of the other outcomes. CONCLUSION: While there was no difference in healing rates between the two treatments, PeG was more cost-effective and associated with fewer adverse events.

Transaxillary robotic-assisted thyroid surgery: technique and results of a preliminary experience on the Da Vinci Xi platform.

BACKGROUND: Robotic thyroidectomy by transaxillary approach (RATS) is regarded as a feasible and safe alternative procedure in selected patients with benign disease or thyroid cancer of low risk, facilitating thyroidectomy with respect to conventional endoscopic approach and offering improved cosmetic results. The Da Vinci Xi surgical system (Intuitive Surgical, Sunnyvale, CA, USA) presents technical advantages over its previous generations, including overhead docking, more compact robotic arms, extended range of motion, and ability for camera to be docked in any arm. This construct supports dissection in smaller spaces with less arm interference and improved view. We present an initial experience of RATS on DVSS Xi in an academic Centre in Italy. METHODS: We conducted a prospective observational study, involving patients with thyroid disease and treated between April 2016 and January 2018. A modified thyroidectomy retractor (Modena retractor, CEATEC Medizintechnik, Germany) was used to lift a musculocutaneous flap and operate gasless. Instrument placement was recorded for each procedure. Each procedure description was broken down into three phases, creation of working space, machine docking with instrument positioning and endoscopic operating technique. Duration of cases was recorded. Patients selected were young women, BMI < 30, thyroid nodule < 5 cm, cytology TIR2 to TIR4 (TIR4:only nodules < 1 cm diameter). RESULTS: Twelve RATS were performed within the learning curve for the robotic technique, 10 lobectomies and 2 total thyroidectomies. No patients required reintervention. Mean duration of surgery was 198.9 min for lobectomy and 210 for thyroidectomy. The same surgical team performed all procedures. No patients presented surgery-related complications, mean stay was 3 days. Decrease in operating time was observed after 8 cases along with more precise preparation of working space. Four arms were used in the first 10 procedures then only three. No recurrent laryngeal nerve dysfunction, no seroma or haematoma were recorded. One patient had transient hypocalcaemia after total thyroidectomy. CONCLUSIONS: Since the early phases of a preliminary experience RATS appeared a safe alternative to open thyroidectomy. Uptake of technique was quick on Xi platform with few technical tweaks over techniques described for Si machines. Careful patient selection is crucial. TRIAL REGISTRATION: Retrospectively registered on 20 july 2018 . TRIAL REGISTRATION NUMBER: researchregistry4272. The Research Registry: https://www.researchregistry.com/browse-the-registry#home/registrationdetails/5b517f08dbc2045aefd7f9b4/.

Efficacy of Intragastric Balloon versus Liraglutide as Bridge to Surgery in Super-Obese Patients.

INTRODUCTION: Bariatric surgery is a safe and effective treatment for obesity, although in super-obese patients (BMI ≥50 kg/m2) it can become challenging for anatomical and anesthesiologic issues. Several bridging therapies have been proposed to increase preoperative weight loss and decrease perioperative morbidity and mortality. The aim of this study was to compare the efficacy and safety of different two-stage approaches in super-obese patients: laparoscopic sleeve gastrectomy (LSG) following preoperative liraglutide therapy versus LSG with preoperative intragastric balloon (IGB) during a 1-year follow-up. METHODS: Clinical records of 86 patients affected by super-obesity who underwent two-stage approach between January 2019 and January 2022 were retrospectively reviewed using a prospectively maintained database. Patients were separated into two groups: those managed with preoperative IGB and those with liraglutide 3.0 mg prior to LSG. Weight (kg), BMI (kg/m2), %EWL, and %EBWL were reported and compared between the two groups at the end of bridging therapy, at 6th month and 12th month postoperatively. Postoperative complications were recorded. RESULTS: Forty-four patients underwent IGB insertion prior to LSG, while 42 were treated with liraglutide. There were no statistical differences in baseline weight and BMI. At the end of preoperative treatment, the group treated with IGB reported a significant reduction in BMI (47.24 kg/m2 vs. 53.6 kg/m2; p < 0.391) compared to liraglutide group. There were no differences recorded between the two groups concerning postoperative complications. At 6 months, the liraglutide group had lower %EWL (15.8 vs. 29.84; p < 0.05) and %EBWL (27.8 vs. 55.6; p < 0.05) when compared to IGB group. At 12 months, the IGB preserved with higher %EWL (39.9 vs. 25; p < 0.05) and %EBWL (71.2 vs. 42; p < 0.05). CONCLUSION: A two-stage therapeutic approach with IGB prior to LSG in super-obese patients could be considered an attractive alternative to liraglutide as bridging therapy before bariatric surgery.

Management and surgical treatment of parathyroid carcinoma: a 6-year experience of a single centre of endocrine surgery unit.

Background: Parathyroid carcinoma (PC) affects 0.1-0.3% of the general population and represents the rarest malignant neoplasms among endocrinological diseases, comprising less than 1%. The best therapeutic treatment and management methods are still debated in the literature. The aim of this study is to evaluate the management and surgical treatment of parathyroid carcinoma after 6 years of enrolment with the Endocrine Surgery Unit of the University Hospital of Bari. Materials and methods: A retrospective observational study was carried out using a prospectively maintained database of patients affected by primary hyperparathyroidism between January 2017 and September 2022. Consecutive patients over 18 years old with a final histopathological finding of PC were included in the study. Patients with secondary or tertiary hyperparathyroidism, parathyroid hyperplasia, and parathyroid adenoma were excluded. All patients underwent follow-up every 6 months for the first 2 years, and annually thereafter. Results: In this study, 9 out of 40 patients affected by hyperparathyroidism were included; 6 (66.6%) were female and 3 (33.3%) were male patients, with a median age of 59 years (IQR 46-62). None had a family history of PC. No mortality was recorded while the incidence of recurrence was 22.2%, with a disease-free survival of 8 and 10 months. Parathyroidectomy was performed in five patients, while four patients underwent parathyroidectomy with concurrent thyroidectomy for thyroid goitre. No intraoperative complications were recorded. Open parathyroidectomy was performed with a mini-cervicotomy in seven patients, while two patients underwent robotic surgery. All patients were discharged on the second postoperative day. Conclusion: PC represents a great challenge in terms of preoperative diagnosis, management and treatment. A surgical approach represents the first best option for PC in referral endocrine surgery units. The early identification of risky patients should be the dominant goal to plan an appropriate therapy and to perform adequate en bloc surgery.

A New Possible Cut-Off of Cytokeratin 19 mRNA Copy Number by OSNA in the Sentinel Node of Breast Cancer Patients to Avoid Unnecessary Axillary Dissection: A 10-Year Experience in a Tertiary Breast Unit.

(1) Background: The main discriminant in breast cancer prognosis is axillary lymph node status. In a select cohort of patients, axillary lymph node dissection (ALND) may be safely spared. This study aimed to determine a new possible cut-off of cytokeratin (CK) 19 mRNA copy number in the SLN to predict cases at high risk of positive ALND. (2) Methods: Clinical records of 1339 patients were retrospectively reviewed and were separated into two groups according to the axillary status (negative: ALNs- and positive ALNs+). Receiver operative characteristic (ROC) curves were used to identify a new optimal cut-off of CK19 mRNA copy number in SLN; (3) Results: Large tumor size and high grade were found mostly in ALNs+. Results from the ROC analyses, with an AUC of 82.1%, identified a new cut-off (9150 CK19 mRNA copies) showing 94% sensitivity, 67.3% specificity, 61.2% positive, and 95.3% negative predictive values; (4) OSNA remains the most-important intra-operative tool to identify patients who can benefit from ALND but with the traditional cut-off, many patients undergo needless ALND. The results of the present study suggest a new cut-off helpful to personalize surgical treatment and avoid unnecessary invasive procedures.

Osteoclast-like stromal giant cells in invasive ductal breast cancer: A case series.

INTRODUCTION: Breast Cancer with osteoclast-like stromal giant cells (OLGCs) is a rare pattern of invasive non-special type ductal carcinoma. The OLGCs are specific type of macrophage and are likely distinct from true osteoclasts. The aim of this case series was to describe the characteristics of this invasive ductal carcinoma rare histotype. PRESENTATION OF CASES: The authors present the cases of two young women that, during national screening, discovered with mammography X-ray a breast lump suspected for malignancy. The core needle biopsy confirmed the malignancy of both nodule and in one patient the histological analysis revealed pre-operative OLGCs. In both cases the sentinel lymph node biopsy was negative therefore a quadrantectomy without axillary lymphadenectomy was done. The definitive histopathological examination was positive for invasive ductal carcinoma with OLGCs and CD 68 marker positivity. After surgery, patients underwent adjuvant therapy and multidisciplinary follow-up. DISCUSSION: The origin and mechanism for developing osteoclast-like giant cells is unknown. The OLGCs directly descend from the precursors of the monocyte-macrophage. The rarity of this entity often promotes a misleading diagnosis, with >50 % of erroneous diagnosis of benign lesion. The prognostic significance of OLGCs in breast cancer is controversial, however it doesn't seem to influence the axillary lymph nodes spread. The presence of preoperative OLGCs didn't modify our surgical and oncological approach. CONCLUSION: Breast Cancer with OLGCs is a rare tumour that has a similar prognosis to other carcinomas of identical grade and stage in most cases. The rarity and characteristics of this neoplasm require personalized treatments, discussed by a multidisciplinary team.

Outcome and risk factors for local recurrence after breast conserving surgery in patients affected by ductal carcinoma in situ.

BACKGROUND: Ductal carcinoma in situ (DCIS) is a tumor with long term survival and low local recurrence rate. Although the progression of these lesions is rare, the current guidelines recommend breast conservating surgery (BCS) with adjuvant radio and/or endocrine therapy, often resulting in an overtreatment for patients. The aim of this single-center study was to evaluate the long-term outcome of the breast conservating surgery of DCIS followed by adjuvant radio and/or endocrine therapy and to identify prognostic factors associated with the risk of recurrence. METHODS: Patients treated for DCIS with BCS and radiation therapy between March 2006 and January 2019 were retrospectively reviewed using a prospectively maintained database. Analysis of the potential risk factors was performed to evaluate the risk of subsequent ipsilateral and contralateral recurrence. RESULTS: Out of 2894 patients, two hundred eighty-eight (10%) patients were treated for DCIS. After a median follow-up of 85 months (IQR 27-124), the incidence of recurrence was 6% (18 patients). Nine of them (3%) had an ipsilateral local recurrence (LR) with a median disease-free survival of 19 months (IQR 12-35). The remaining nine patients had contralateral metachronous breast cancer (CBC) with a median DFS of 29 months (IQR 14-36). Margin status, multifocality, hormone receptor status and Her-2/Basal-like subtype were identified as risk factors for the local recurrence with a OR of 5.58 (1.44-21.54), 7.46(1.89-24.48) 0.25 (0.06-0.96) and 4.86 (1.26-18.71) respectively. CONCLUSIONS: DCIS had been confirmed to have long term survival. Margin status, multifocality, hormone receptor status and Her-2/Basal-like subtype could be identified as reliable risk factors for the progression of the disease.

Histopathologic findings on removed stomach after sleeve gastrectomy. Do they influence the outcome?

Little is known about the role of chronic gastritis on weight loss after laparoscopic sleeve gastrectomy (LSG). This study aims to investigate the relationship between histopathologic findings of gastric specimens, excess weight loss (% EWL), and excess BMI loss (% EBL) at 6 and 12 months follow up after LSG. We retrospectively reviewed the clinical records of 95 patients who had undergone LSG between January 2017 and December 2019. Based on the histopathological findings of gastric resection specimens, patients were divided into those with chronic gastritis (CG) and those without chronic gastritis (NoCG) and compared for their % EWL and % EBL at 6 and 12 months. The mean BMI was 44.74 kg/m2 in the CG group and 44.14 kg/m2 in the NoCG group. At 6 months follow up, the CG group had a mean % EWL of 45.7 and % EBL of 40.5, while NoCG had a mean % EWL of 51.1 and % EBL of 46.7. After 1-year follow-up, the CG group had a mean % EWL of 53.1 and a % EBL of 44.8, while the NoCG group had a % EWL of 54.1 and % EBL of 44. This observational study does not support the hypothesis that the occurrence of chronic gastritis can affect postoperative % EWL and % EBL.

Staple line reinforcement with nebulized cyanoacrylate glue in laparoscopic sleeve gastrectomy: A propensity score-matched study.

BACKGROUND: A dreaded complication of laparoscopic sleeve gastrectomy (LSG) is suture leak. The study aimed to assess the efficacy of the nebulized comonomer Glubran 2® (N-butyl-cyanoacrylate + metacrylosysolfolane) applied to the LSG staple line. METHODS: A propensity-matched comparison analysis was conducted in 125 patients undergoing LSG between 2017 and 2019. Groups included those treated with Glubran® (group 1, n = 70) and those without Glubran® treatment (group 2, n = 55). RESULTS: There were differences in the mean body mass index (44.4 vs 43 kg/m2; P < 0.05) between the groups. There was a non-significant increase in the operative time for group 1 compared with group 2 (97 ± 8 vs 93.8 ± 10.7 min; P = 0.07), with a greater amount of estimated blood loss (94.5 mL vs 87.8; P < 0.01). There were more severe complications in group 2 over group 1 cases (8 vs 0%; P < 0.05), although postoperative bleeding did not differ between the two groups (1.4 vs 5.4%). There were no postoperative leaks in group 1 patients, but there were two leaks in group 2 cases with an increased length of hospital stay in patients with a leak. CONCLUSION: Glubran® LSG support may reduce leak risk without increasing operating time.

Laparo-endoscopic management of chole-choledocholithiasis: Rendezvous or intraoperative ERCP? A single tertiary care center experience.

Introduction: The management of chole-choledocholithiasis remains a matter of debate to preserve minimal invasive management and different options have been proposed, with single- or two-stage approaches. Two techniques of single-stage approach are intraoperative ERCP and laparoscopic rendezvous, which have the great advantage of reducing the length of hospital stay with increased patient compliance. This retrospective study aims to evaluate and compare the efficacy and safety of intraoperative ERCP and rendezvous technique for more than 15 years. Materials and methods: Clinical records of 113 patients who underwent single-stage management for chole-choledocholithiasis between January 2003 and December 2020 were retrospectively reviewed using a prospectively maintained database. Patients were separated into two groups: those managed with intraoperative ERCP and those with rendezvous, and their intraoperative and postoperative parameters were compared. All patients were followed up for 6 months in an outpatient setting. Results: A total of 68 (60%) patients were treated with intraoperative ERCP, while the remaining 45 (40%) were treated with rendezvous. There were no significant differences in terms of comorbidities. ERCP was performed with a median operative time of 145 min (104-168) and an endoscopic time of 27 min (15-36). Meanwhile, rendezvous was performed with a significantly lower operative [120 min (94-147)] and endoscopic time [15 min (12-22)]. No intraoperative complications were recorded. Patients treated with rendezvous had a significantly shorter median hospitality stay [4 (3-5) vs. 3 (2-4) days, p < 0.05]. No hospital readmissions or mortalities were observed in either group after 30 days. Ten mild pancreatitis cases were observed, mainly in the intraoperative ERCP group (9 vs. 1, p < 0.05), and all were treated conservatively. Only two patients treated with intraoperative ERCP developed biliary complications later on. Conclusion: Laparoscopic rendezvous should be considered a preferable alternative to intraoperative ERCP for the treatment of patients with concomitant CBD stones and gallstones.

Management and Treatment of External Hemorrhoidal Thrombosis.

Background: External hemorrhoidal thrombosis (EHT) is a common complication of hemorrhoidal disease. This condition causes extreme pain, likely resulting from internal anal sphincter hypertonicity, which traps the hemorrhoids below the dentate line thus leading to congestion and swelling. The choice of treatment remains controversial and both conservative and surgical options have been proposed in the last decades. Methods: This mini-review focuses on the most relevant studies found in literature evaluating conservative and surgical management of EHT. Special conditions such as pregnancy and EHT in elderly patients have been considered. Results: Traditionally, symptoms duration represents the discriminant in the choice between medical and surgical treatment. Several Coloproctological Societies considered conservative treatment as the first-line approach to EHT and a variety of options have been proposed: wait and see, mixture of flavonoids, mix of lidocaine and nifedipine, botulinum toxin injection and topical application of 0.2% glyceryl trinitrate. Meanwhile, different surgical treatments are recommended when EHT fails to respond to conservative management or when symptoms onset falls within the last 48-72 h: drainage with radial incision, conventional excision, excision under local anesthesia and stapled technique. Conclusion: The management and treatment of EHT is still controversial since no specific guidelines have been published. Both medical and surgical treatment have been proven effective but randomized clinical trials and structured consensus-based guidelines are warranted.

Gastroesophageal reflux after sleeve gastrectomy. Fact or fiction?

BACKGROUND: One of the most controversial issues surrounding laparoscopic sleeve gastrectomy is the development of gastroesophageal reflux disease following surgery. The aim of the study was to evaluate the occurrence of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy and to analyze patients' weight loss, comorbidities, and quality of life after surgery. METHODS: The clinical records of 52 patients submitted to laparoscopic sleeve gastrectomy between January and November 2018, with 3 years of follow-up, were retrospectively reviewed. At the end of the follow-up period, the patients underwent screening endoscopy, and those with postoperative esophagitis were submitted to endoscopic biopsies and pH-impedance monitoring (MII-pH). The presence of gastroesophageal reflux disease symptoms was assessed using the modified clinical DeMesteer score questionnaire. The Bariatric Analysis and Reporting Outcome System score and 36-Item Short Form Health Survey were used to assess the postoperative quality of life. RESULTS: In the preoperative work-up, only 7.6% of patients had signs of esophagitis at esophagogastroduodenoscopy, whilst at 3-year follow-up, 50% of them had endoscopic signs of gastroesophageal reflux disease. Twenty-one out of 26 patients with signs of esophagitis agreed to undergo MII-pH. The median DeMesteer score questionnaire was 4.5, with only 4 patients (19%) exhibiting a value greater than the pH cut-off value (14.72), indicative of gastroesophageal reflux disease. MII-pH data analysis showed the presence of gastroesophageal reflux disease in 5 patients. An excellent outcome on the Bariatric Analysis and Reporting Outcome System score was reported in 50% of patients, and all 8 domains from the 36-Item Short Form Health Survey improved significantly. CONCLUSION: This study showed an improvement in these patients' quality of life and the limited refluxogenic nature of laparoscopic sleeve gastrectomy at 3-year follow-up when diagnosis of gastroesophageal reflux disease is based on the Lyon consensus.

201 cases of foreign body ingestion in a Surgical Emergency Unit A 16-year retrospective study.

AIM: The aim of this study is to analyse clinical characteristics of FB ingestion and predictive factors for complications, in order to reduce mortality and morbidity. MATERIALS AND METHODS: A retrospective study of emergency surgical consultation records has been carried out from June 2005 through June 2015 yielded 201 episodes with the diagnosis of ingestion of foreign objects at the Surgical Unit of the University of Bari. RESULTS: Natural Removal in 44,8% of cases; Endoscopic retrieval in 42,4%, Surgical Procedures 4,4%. Statistical analysis was based on multivariate analysis and the model R2 of the Naegelkerke value. DISCUSSION: First of all, the approach to ingestion should be endoscopic. The second approach is surgical in selected cases. The most frequent site of impaction were oesophagus, stomach and right colon. An EGD proved to be the most used procedure with a no morbidity and no mortality. CONCLUSION: The ingestion of foreign bodies is a frequent, complex and expensive condition to treat. Observation and endoscopy are the most appropriate procedures to be considered to manage the ingestion of FB in Emergency Surgery Unit. KEY WORDS: Emergency surgery, Foreign bodies, Ingestion.

Safety and Effectiveness of Tailored Hemorrhoidectomy in Outpatients Setting.

Introduction: Single or double prolapsed pile instead of full muco-hemorrhoidal prolapse is a common finding in patients with symptomatic III or IV degree hemorrhoids. For this selected group of patients, relief of symptoms could be achieved by managing the single/double prolapsed piles instead of performing traditional hemorrhoidectomy. The aim of this single-center study was to evaluate the safety and medium- and long-term effectiveness of an outpatient tailored Milligan-Morgan hemorrhoidectomy (MMH) performed under local anesthesia (LA). Material and methods: Clinical records of 202 patients submitted to outpatient tailored MMH, under LA and without anal dilation, treated between 2013 and 2020, were retrospectively reviewed using a prospectively maintained database and completed by a telephone interview or outpatient consultation. Postoperative pain score, the need for painkillers, postoperative complications and symptoms recurrence, return to working activities, and patient grading assessment scale were recorded. Results: Thirty-five (17%) out of 202 patients recruited were lost to the follow-up. One hundred and fifty-two and 15 patients underwent a single and double pile hemorrhoidectomy, respectively. With regard to postoperative outcomes, visual analogue scale (VAS) decreased from a median value of 4 [interquartile range (IQR) 2-6] on the day of surgery to 1 (IQR 0-4) on the 10th postoperative day (p < 0.001). Sixty-one patients (37%) needed oral painkillers during the 1st week after surgery. There was no mortality or major postoperative complication. Bleeding requiring hospital readmission was reported in seven (4%) patients, and one patient underwent emergency surgery with no need for blood transfusion. No postoperative urinary retention, anal incontinence, or stricture occurred in the series. During the median follow-up of 39 (IQR 12-60) months, 26 patients (16%) reported symptoms of recurrence but only six underwent traditional MMH. Recovery to normal activity occurred within a median period of 6 days (IQR 3-10) and the Clinical Patient Grading Assessment Scale (CPGAS) at 1 year after surgery was reported to be a "good deal better." Conclusions: Tailored MMH performed under LA in an ambulatory setting can be considered a safe and effective technique with high compliance and satisfaction of patients.