Colorectal Cancer Diagnosis through Breath Test Using a Portable Breath Analyzer-Preliminary Data.

Screening methods available for colorectal cancer (CRC) to date are burdened by poor reliability and low patient adherence and compliance. An altered pattern of volatile organic compounds (VOCs) in exhaled breath has been proposed as a non-invasive potential diagnostic tool for distinguishing CRC patients from healthy controls (HC). The aim of this study was to evaluate the reliability of an innovative portable device containing a micro-gas chromatograph in enabling rapid, on-site CRC diagnosis through analysis of patients' exhaled breath. In this prospective trial, breath samples were collected in a tertiary referral center of colorectal surgery, and analysis of the chromatograms was performed by the Biomedical Engineering Department. The breath of patients with CRC and HC was collected into Tedlar bags through a Nafion filter and mouthpiece with a one-way valve. The breath samples were analyzed by an automated portable gas chromatography device. Relevant volatile biomarkers and discriminant chromatographic peaks were identified through machine learning, linear discriminant analysis and principal component analysis. A total of 68 subjects, 36 patients affected by histologically proven CRC with no evidence of metastases and 32 HC with negative colonoscopies, were enrolled. After testing a training set (18 CRC and 18 HC) and a testing set (18 CRC and 14 HC), an overall specificity of 87.5%, sensitivity of 94.4% and accuracy of 91.2% in identifying CRC patients was found based on three VOCs. Breath biopsy may represent a promising non-invasive method of discriminating CRC patients from HC.

Sclerotherapy with 3% polidocanol foam to treat second-degree haemorrhoidal disease: Three-year follow-up of a multicentre, single arm, IDEAL phase 2b trial.

BACKGROUND: Sclerotherapy with 3% polidocanol foam is becoming increasingly popular for the treatment of symptomatic I-II or III degree haemorrhoidal disease (HD). However, there are no studies that have reported a follow-up of more than 1 year. The purpose of this study was to analyse the long-term outcomes of sclerotherapy with 3% polidocanol foam in the treatment of II-degree HD. METHODS: This was an open label, single-arm, phase 2b trial conducted in 10 tertiary referral centres for HD. A total of 183 patients with II-degree HD, aged between 18 and 75 years with symptomatic HD according to the Goligher classification and unresponsive to medical treatment, were included in the study and underwent sclerotherapy with 3% polidocanol foam. The efficacy was evaluated in terms of bleeding score, haemorrhoidal disease symptom score (HDSS) and short health scale for HD (SHS-HD) score. Successful treatment was defined as the complete absence of bleeding episodes after 7 days (T1) according to the bleeding score. RESULTS: The overall success rate ranged from 95.6% (175/183) at 1 year to 90.2% (165/183) after the final 3 year follow-up. The recurrence rate, based on the primary outcome, ranged from 12% (15/125) to 28% (35/125). The greatest increase in recurrence (15) was recorded between 12 and 18 months of follow-up, then another five between 18 and 24 months. Both the HDSS and the SHS score remained statistically significant (p < 0.001) from a median preoperative value of 11 (10-13) and 18 (15-20) to 0 (0-2) and 4 (0-4), respectively. Symptom-free (HDSS = 0) patients, excluding patients converted to surgery, increased from 55.5% (101/182) at 1 year to 65.1% at 3 years (110/169). There were no intraoperative complications in redo-sclerotherapy nor additional adverse events (AEs) compared to the first 12 months. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is gradually establishing itself in the treatment of bleeding HD due to its repeatability, safety, convenience in terms of direct and indirect costs with the absence of discomfort for the patient as well as AEs rather than an excellent overall success rate.

Clinical and functional outcome of surgery for posttraumatic cloacal deformity.

AIM: Cloacal deformity is a disabling condition that severely affects a patient's quality of life. Surgery to repair cloacal deformity remains the mainstay of treatment. The aim of this study is to assess the clinical and functional outcome of patients treated for traumatic cloacal deformity by three different techniques. METHOD: A retrospective multicentre study was carried out using data from women operated on for cloacal deformity between 2015 and 2019. Demographic characteristics, the presence of urinary and/or faecal incontinence and manometric findings were collected. The main outcome measures were represented by St Mark's and Rockwood faecal incontinence quality of life scores. RESULTS: Thirty eight women with a median age of 34 years [interquartile range (IQR) 31-39 years] were enrolled. Perineoplasty was performed in 23 patients by direct suture of the rectovaginal septum, in five using the X-flap and in 10 by the Singapore flap. Median resting and squeezing pressures increased significantly from 28.15 (IQR 23-32.7) cmH2 O to 45 (IQR 31-60.7) cmH2 O (p = 0.0001) and from 47 (IQR 41.2-54.7) cmH2 O to 97.2 (IQR 80-118) cmH2 O (p = 0.0001), respectively. Maximum tolerable volume improved from 120 (IQR 90-137.5) ml to 137.5 (IQR 120-150) ml (p = 0.002). The St Mark's score decreased from 18 (IQR 14-20) to 4.5 (IQR 2-8) after 20 months (p = 0001). Sexual activity was confirmed by 16 patients preoperatively and by 27 postoperatively. A diverting stoma was performed in three patients after X-flap perineoplasty and in 14 treated by direct closure. No significant differences were found pre- and postoperatively between the three groups. CONCLUSION: Regardless of the technique used, surgical repair significantly improves both clinical and functional outcomes irrespective of the presence of a covering stoma.

Anoplasty for anatomical anal stenosis: systematic review of complications and recurrences.

AIM: The optimal surgical treatment for anatomical anal stenosis (AS) remains to be determined. The aim of this study was to determine the rates of complications and recurrence after anoplasty for anatomical AS and, wherever feasible, compare the outcomes for the various techniques. METHOD: A PROSPERO-registered systematic review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Medline, PubMed, Embase, Cochrane Library of Systematic Review, Scopus and Web of Science were searched for articles published up to May 2021. Studies that assessed the outcomes of anoplasty in adult patients with anatomical AS were selected. The primary outcomes were complications and recurrence. The methodological quality of studies was appraised using the Joanna Briggs Institute critical appraisal tools. RESULTS: From the total of 2705 unique screened records, 151 were assessed for eligibility. Only 29 studies (two prospective) met the inclusion criteria, reporting data on 556 patients [mean age 53 (18-83) years, 46% female]. Previous history of surgery for haemorrhoidal disease accounted for three quarters of cases. A total of 14 types of anoplasty were found, with the Y-V flap being the most performed technique [27% of cases (n = 149)]. Complications frequently occurred, with a pooled prevalence of 10.2% (95% CI 3.9%-24.1%) after Y-V flap and 11.5% (5.3%-23.0%) after rhomboid/diamond flap. Patients undergoing house flap achieved better results in terms of clinical improvement, satisfaction and quality of life compared with Y-V flap and rhomboid/diamond flap. When considering only studies with at least 12 months of follow-up, the pooled prevalence of recurrence was 4.7% (2.2%-9.8%), with significantly higher rates observed in the prospective versus retrospective series [pooled prevalence 18.9% (11.5%-29.5%) vs. 3.6% (1.7-7.8%), respectively; p < 0.001]. CONCLUSION: Both complications and recurrence were significantly lower after house flap compared with rhomboid/diamond and Y-V flap. Better designed multicentre studies with longer follow-up are needed to confirm these findings. PROSPERO REGISTRATION NUMBER: CRD42021239493.

Lessons from the COVID-19 pandemic: remote coaching in bariatric surgery.

BACKGROUND: The development of fast internet connection has stimulated different types of video-assisted teaching programs. However, a remote mentoring with the proctor not on site has never been reported in bariatric surgery. We described our experiences with remote telementoring for laparoscopic sleeve gastrectomy. METHODS: A qualified general surgeon at the beginning of his bariatric practice performed a series of 8 laparoscopic sleeve gastrectomies (LSG) while tutored by an experienced bariatric surgeon connected from a different city through a specific videoconferencing platform. Data on demographics at baseline, operative time, hospital stay, intraoperative early, and late complications were collected. RESULTS: Mean age and BMI of patients were 36.9 ± 9.6 years old and 41.8 ± 1.7 kg/m2. All procedures were carried out without conversion to open or complications. Mean operative time was 112.4 ± 21.9 min while the hospital stay was 3.5 ± 0.5 days. Operative time significantly decreased after the fourth operation. CONCLUSIONS: Remote coaching appears to be possible and safe for LSG.

Transanal reinforcement of low rectal anastomosis versus protective ileostomy after total mesorectal excision for rectal cancer. Preliminary results of a randomized clinical trial.

AIM: The study aimed to show if transanal reinforcement of the suture line can prevent anastomotic leakage (AL) after rectal cancer surgery, thus avoiding the need for a covering ileostomy. METHODS: This is a prospective, multicentre, parallel-arm randomized controlled equivalence trial. After standard total mesorectal excision, patients with anastomotic line at 1-3 cm from the dentate line were randomized to have transanal suture reinforcement (TAR group) or protective ileostomy (PI group). RESULTS: Twenty-nine patients had PI, 25 had TAR. The two groups were comparable both for baseline characteristics and intra-operative aspects. Clinically evident AL occurred in four (16%) and five (17.24%) patients of the TAR and PI group, respectively, resulting in a difference of -1.20% (90% CI -17.93, 15.45), while subclinical AL at proctography was absent in 15 (65.22%) and 13 (50%) patients of the TAR and PI groups, respectively, resulting in a difference of 15% (90% CI -7.74 to 38.17). CONCLUSION: Preliminary data suggest that transanal reinforcement of the suture line performed in rectal cancer patients with suture line at 1-3 cm from the dentate line carries a similar (even if not equivalent) AL rate to covering ileostomy, suggesting that a covering ileostomy could be avoided in this selected group of patients. This indication needs to be addressed with future larger trials (clinicaltrials.gov ID number NCT02279771).

Efficacy of cyanoacrylate in the prevention of delayed bleeding after endoscopic mucosal resection of large colorectal polyps: a pilot study.

BACKGROUND: Postoperative bleeding is a common complication after endoscopic polypectomy, particularly after endoscopic mucosal resection (EMR) of large non-pedunculated polyps, despite prophylactic clipping can reduce its occurrence. Cyanoacrylate glue has recently been proposed as a useful tool in reducing bleeding in surgery because of its adhesive and haemostatic properties. The aim of this study is to evaluate the usefulness of endoscopic application of a modified cyanoacrylate glue in the prevention of early or delayed post EMR bleeding. METHODS: This is a pilot study. Inclusion criteria were patients between 18 and 75 years old affected by sessile or flat colonic polyps larger than 2 cm. Patients enrolled in the study were randomized in two groups: group A (EMR) and group B (EMR with the application of 0.3 ml of N-butyl-2-cyanoacrylate + methacryloxysulfolane-Glubran 2®). RESULTS: Fifteen patients in both group A and B were enrolled. There were no intraoperative complications but haemostatic clipping was necessary in 3 patients in each group because of active bleeding. Delayed (after 24 h) bleeding occurred in two patients (13.3%) in group A requiring hospital readmission and re-do endoscopy with apposition of haemostatic clips. No case of bleeding was recorded in group B (p = 0.48). CONCLUSION: The results of this pilot study suggest a potential role of local spray application of Glubran®2 in reducing post-procedural bleeding.

Three-plane Model to Standardize Laparoscopic Right Hemicolectomy with Extended D3 Lymph Node Dissection.

AIM: The purposes of this study were to create a "three-plane model" for laparoscopic right hemicolectomy and to compare short-term outcomes of anterior medial-to-lateral (aM-to-L) and caudal-to-cranial access by retroperitoneal tunneling (Ca-to-Cr), as described based on the three-plane model. METHODS: A three-plane model was developed to clarify the steps of an operation. Consecutive cases of right colon cancer were operated upon with an aM-to-L approach in the earlier period and then with a Ca-to-Cr approach, and postoperative outcomes were evaluated. Short-term results were compared. RESULTS: Sixty-two patients were divided into aM-to-L (n=29) and Ca-to-Cr (n=33) groups. The two groups did not differ in terms of the patients' baseline characteristics. Median operative time was 220 min (IQR 190-260) for the aM-to-L group and 222.5 min (IQR 180-255) for the Ca-to-Cr group (p=0.73). Estimated blood loss was similar in both groups (p=0.13). Median length of hospital stay was 6 days (IQR 5-8) in the aM-to-L group and 7 days (IQR 6-9) in the Ca-to-Cr group (p=0.17). Median number of harvested lymph nodes was 45.5 (IQR 25-44.9) in the aM-to-L group and 30 (IQR 18-48.5) in the Ca-to-Cr group (p=0.34). CONCLUSION: The approach used to reach the superior mesenteric vessels for laparoscopic right hemicolectomy with D3 lymph node dissection does not affect the short-term outcome of the operation. The present three-plane model gives surgeons additional insight to perform this operation.

Clinical evidence and rationale of mesoglycan to treat chronic venous disease and hemorrhoidal disease: a narrative review.

Chronic venous disease (CVD) and hemorrhoidal disease (HD) are among the most common vascular diseases in the world, with CVD affecting 22-41% of the population in Europe and HD having a point prevalence of 11-39%. The burden is substantial in terms of the effect of symptoms on patients' health-related quality of life (HRQoL) and direct/indirect medical costs. Treatment begins with lifestyle changes, compression in CVD and topical therapies in HD, and escalates as needed through oral therapies first and eventually to surgery for severe disease. CVD and HD share etiological features and pathological changes affecting the structure and function of the tissue extracellular matrix. Mesoglycan, a natural glycosaminoglycan (GAG) preparation composed primarily of heparan sulfate and dermatan sulfate, has been demonstrated to positively impact the underlying causes of CVD and HD, regenerating the glycocalyx and restoring endothelial function, in addition to having antithrombotic, profibrinolytic, anti-inflammatory, antiedema and wound-healing effects. In clinical trials, oral mesoglycan reduced the severity of CVD signs and symptoms, improved HRQoL, and accelerated ulcer healing. In patients with HD, mesoglycan significantly reduced the severity of signs and symptoms and the risk of rectal bleeding. In patients undergoing excisional hemorrhoidectomy, adding mesoglycan to standard postoperative care reduced pain, improved HRQoL, reduced incidence of thrombosis, and facilitated an earlier return to normal activities/work, compared with standard postoperative care alone. The clinical effects of mesoglycan in patients with CVD or HD are consistent with the agent's known mechanisms of action.

Thrombosed external hemorrhoids during pregnancy: surgery versus conservative treatment.

The management of thrombosed external hemorrhoids (TEH) during pregnancy is still under debate because of the fear of potential adverse effects on the fetus. This study aims to compare efficacy and safety of conservative versus surgical treatment of acute TEH in pregnant women. Furthermore, the outcome of two different surgical approaches was evaluated. This is a prospective observational study including a sub-analysis on two randomized groups of pregnant women affected by TEH. The primary outcome measured was the impact of conservative and surgical treatment defined in terms of VAS, clinical patient grading assessment scale (CPGAS) and the SF-12 questionnaire. In a randomized sub-analysis of the surgical treatment, the outcome of local excision (LE) versus thrombectomy (TE) was compared. Fifty-three patients entered the study. Twenty-six patients had conservative treatment and 22 underwent surgery. Within the surgical group, 8 were randomized for TE and 14 for LE. VAS, SF-12 and CPGAS improved in both groups after 3 and 10 days from the treatment. However, physical (PCS) and mental health (MCS) domains of the SF-12 and CPGAS showed a significant difference in favor of surgery on the 10th day (PCS: p < 0.002 and MCS: p = 0.03; CPGAS: p = 0.002). The surgical group showed an earlier significant reduction of pain on the 3rd day (p = 0.0004). In the surgical group, randomization was halted due to ethical concerns arising from a notable difference in the primary end point between subgroups during interim analysis. Specifically, the re-thrombosis rate was 38% (3/8) after TE and 7% (1/14) after LE. No complications occurred for either mothers or fetuses. Both surgical and conservative treatments are safe and effective. However, surgery allows a faster relief of anal pain. Thrombectomy is associated with higher risk of re-thrombosis when compared to local excision (clinicaltrials.gov ID number NCT04588467).

Undeserved authorship in surgical research: an underestimated bias with potential side effects on academic careers.

The incidence of courtesy authorship in research over time has probably increased due to the enormous pressure to publish to increase the bibliometric indexes necessary to achieve an academic role. The aim of this survey was to quantify and characterize this research malpractice among a very selected group of surgeons from different surgical specialties belonging to the European Association of Surgery (ESA). E-mail addresses for the invitation to take part to the survey were collected by the Twenty-eighth Annual Meeting final program. Five-item were designed and developed by the authors using an online platform. Eighty-six members from 21 countries completed the survey (female/male ratio: 0.09). In the last 10 years, almost half of the responders (41, 47.7%, 37 academics) have included colleagues for courtesy authorship. The most common reason of courtesy authorships was to support the academic career of another researcher (62.5%). Other reasons were fear of retaliation (12.5%), reciprocal authorship (12.5%) or support for a partner (10%). This survey showed that undeserved authorship is sadly confirmed to be a common research misconduct across any countries and medical specialties, even among a very selected group of surgeons with international reputation irrespective of the academic position.

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.

Practice of proctology among general surgery residents and young specialists in Italy: a snapshot survey.

Anal diseases are very common and, in most of the cases, require surgery of minor or medium complexity, and, therefore, are among the most accessible diseases for surgeons in training. Aim of this study is to investigate the status of the training in proctology in Italy. A 31-items questionnaire was administered to residents and young specialists (≤ 2 years) in general surgery, using mailing lists, and the social media accounts of the Italian Society of Colorectal Surgery. Answers from 338 respondents (53.8% males) were included in the final analysis. Overall, 252 respondents (74.5%) were residents and 86 (25.5%) young specialists. Two hundred and fifty-five (75.4%) respondents practiced proctology for the first time early on during their postgraduate training, but only 19.5% did it continuously for ≥ 24 months. Almost all respondents (334; 98.8%) had the chance to participate in proctological procedures, 205 (60.5%) as first surgeon. This percentage decreases according to the complexity of the surgery. In fact, only 11 (3.3%) and 24 (7.1%) of the respondents were allowed to be the first surgeon in more complex proctological diseases such as surgery for rectal prolapse and fecal incontinence. The present survey suggests that, in Italy, most surgeons in training deal with anal diseases. However, only few of them could achieve sufficient professional skills in the management of proctological diseases to be able to practice autonomously as young specialists.

Identification of a characteristic VOCs pattern in the exhaled breath of post-COVID subjects: are metabolic alterations induced by the infection still detectable?

SARS-CoV-2 is expected to cause metabolic alterations due to viral replication and the host immune response resulting in increase of cytokine secretion and cytolytic activity. The present prospective observational study is addressed at exploring the potentialities of breath analysis in discrimination between patients with a documented previous history of symptomatic SARS-CoV-2 infection and, at the moment of the enrollment, exhibiting a negative nasopharyngeal swab and acquired immunity (post-COVID) and healthy subjects with no evidence of previous SARS-CoV-2 infection (no-COVID). The main purpose is to understand if traces of metabolic alterations induced during the acute phase of the infection are still detectable after negativization, in the form of a characteristic volatile organic compound (VOC) pattern. An overall number of 60 volunteers aged between 25 and 70 years were enrolled in the study (post-COVID: n.30; no-COVID: n. 30), according to well-determined criteria. Breath and ambient air samples were collected by means of an automated sampling system (Mistral) and analyzed by thermal desorption-gas chromatography-mass spectrometry (TD-GC/MS). Statistical tests (Wilcoxon/Kruskal-Wallis test) and multivariate data analysis (principal component analysis (PCA), linear discriminant analysis) were performed on data sets. Among all compounds detected (76 VOCs in 90% of breath samples), 5 VOCs (1-propanol, isopropanol, 2-(2-butoxyethoxy)ethanol, propanal and 4-(1,1-dimethylpropyl)phenol) showed abundances in breath samples collected from post-COVID subjects significantly different with respect to those collected from no-COVID group (Wilcoxon/Kruskal-Wallis test,p-values <0.05). Although not completely satisfactory separation between the groups was obtained, variables showing significant differences between the two groups and higher loadings for PCA are recognized biomarkers of COVID-19, according to previous studies in literature. Therefore, based on the outcomes obtained, traces of metabolic alterations induced by SARS-CoV-2 infection are still detectable after negativization. This evidence raises questions about the eligibility of post-COVID subjects in observational studies addressed at the detection of COVID-19. (Ethical Committee Registration number: 120/AG/11).

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.