Late is too late? Surgical timing and postoperative complications after primary ileocolic resection for Crohn's disease.

BACKGROUND: Despite the recent advances in medical therapy, the majority of patients with Crohn's disease (CD) still require surgery during the course of their life. While a correlation between early primary surgery and lower recurrence rates has been shown, the impact of surgical timing on postoperative complications is unclear. The aim of this study is to assess the impact of surgical timing on 30-day postoperative morbidity. METHODS: This is a retrospective analysis of a prospectively collected database of 307 consecutive patients submitted to elective primary ileocolic resection for CD at our institution between July 1994 and July 2018. The following variables were considered: age, gender, year of treatment, smoking habits, preoperative steroid therapy, presence of fistula or abscess, type of anastomosis, and time interval between diagnosis of CD and surgery. Univariate and multivariate logistic regressions were performed to examine the association between risk factors and complications. RESULTS: Major complications occurred in 29 patients, while anastomotic leak was observed in 16 patients. Multivariate logistic regression analysis showed that surgical timing in years (OR 1.10 p = 0.002 for a unit change), along with preoperative use of steroids (OR 5.45 p < 0.001) were independent risk factors for major complications. Moreover, preoperative treatment with steroids (6.59 p = 0.003) and surgical timing (OR 1.10 p = 0.023 for a unit change) were independently associated with anastomotic leak, while handsewn anastomosis (OR 2.84 p = 0.100) showed a trend. CONCLUSIONS: Our results suggest that the longer is the time interval between diagnosis of CD and surgery, the greater is the risk of major surgical complications and of anastomotic leak.

Initial clinical experience with a novel flexible endoscopic robot for transanal surgery.

BACKGROUND: The Flex® Robotic System (Medrobotics, Raynham, MA, USA) is the first miniaturised flexible endoscopic robot that aims to allow surgical manoeuvres beyond the area currently reached by transanal endoscopic microsurgery. The aim of this study is to evaluate our initial clinical experience with this novel tool. METHODS: We prospectively collected all consecutive cases of local excisions of rectal lesions performed with the Flex® Robotic System performed at the Department of Surgical Sciences of the University of Turin between October 2018 and December 2019. Indications were benign, or early rectal lesions judged unsuitable for endoscopic removal, within 20 cm of the anal verge. Debriefing meetings after each procedure allowed technology assessment leading to the modification, development, and implementation of tools according to the clinical experience. We analysed the data in terms of the safety and efficacy of treatment. RESULTS: Between October 2018 and February 2020, 26 patients were treated. We performed a full-thickness excision in 14 patients and a submucosal dissection in 12. The median operating time was 115 min (range 45-360 min). In six patients (23.1%), we converted to standard transanal endoscopic operation (TEO®) (Karl Storz, Tuttlingen, Germany) to complete the procedure. The 30-day morbidity rate was 11.5% (3/26). Positive resection margins were detected in 4 (15.4%) patients. At a minimum follow-up of 12 months, 2 (7.7%) local recurrences were observed. CONCLUSIONS: This first clinical series demonstrates that the Flex® Robotic System is a fascinating technology that deserves further development to increase surgical dexterity, thereby overcoming current technical limitations and improving clinical outcomes.

What predicts the unsuccess of bariatric surgery? An observational retrospective study.

PURPOSE: Bariatric surgery (BS) has been recognized as an effective treatment for most patients with morbid obesity, but a variable range of patients failed to achieve a successful weight-loss. Controversial data are available about predictors of unsuccess. We aimed to retrospectively assess whether clinical baseline characteristics of patients submitted to sleeve gastrectomy (SL) or gastric bypass (GBP) were associated with unsuccessful weight-loss after 12 and 24-month follow-up. METHODS: Three hundred patients who underwent BS from the 1st January 2016, with at least 24-months follow-up, were enrolled. Patients were divided according to their percentage of excess weight-loss (%EWL) either < 50% or ≥ 50% after 12 and 24-month follow-up. RESULTS: None of the patients was lost at follow-up; 56 (18.7%) patients showed a %EWL < 50% at 24 months. Age, neck circumference, obstructive sleep apnea (OSA) were significantly higher, while total cholesterol and %EWL 6-months lower in those with %EWL < 50% at 12-months. Age, neck circumference, male and OSA rates were increased, while %EWL at 6-months lower in patients with %EWL < 50% at 24-months. In a multiple regression model, age (OR = 1.076; 95% CI 1.029-1.125; p = 0.001; OR = 1.066; 1.027-1.107; p < 0.001) and %EWL at 6-months (OR = 0.876; 0.840-0.913; p < 0.001; OR = 0.950; 0.928-0.972; p < 0.001) were associated with %EWL < 50% both at 12- and 24-months, respectively, and neck circumference (OR = 1.142; 1.011-1.289; p = 0.032) with %EWL < 50% at 24-months. CONCLUSION: Older age, larger neck circumference, and %EWL at 6-months were significantly associated with BS unsuccess, showing almost 90% of those patients an unsuccessful weight-loss early after surgery. Further larger studies with longer follow-up are needed to confirm these results.

Pre-operative micronutrient deficiencies in patients with severe obesity candidates for bariatric surgery.

PURPOSE: In patients with obesity, micronutrient deficiencies have been reported both before and after bariatric surgery (BS). Obesity is a chronic pro-inflammatory status, and inflammation increases the risk of micronutrient malnutrition. Our objective was to assess in pre-BS patients the prevalence of micronutrient deficiencies and their correlation with blood values of C-reactive protein (CRP). METHODS: Anthropometric data, instrumental examinations, and blood variables were centrally measured in the first 200 patients undergoing a pre-BS evaluation at the "Città della Salute e della Scienza" Hospital of Torino, starting from January 2018. RESULTS: At least one micronutrient deficiency was present in 85.5% of pre-BS patients. Vitamin D deficiency was the most prevalent (74.5%), followed by folate (33.5%), iron (32%), calcium (13%), vitamin B12 (10%), and albumin (5.5%) deficiency. CRP values were high (> 5 mg/L) in 65% of the patients. These individuals showed increased rate of iron, folate, vitamin B12 deficiency, and a higher number of micronutrient deficiencies. In a multiple logistic regression model, increased CRP levels were significantly associated with deficiencies of vitamin B12 (OR = 5.84; 95% CI 1.25-27.2; p = 0.024), folate (OR = 4.02; 1.87-8.66; p < 0.001), and with the presence of ≥ 2 micronutrient deficiencies (OR = 2.31; 1.21-4.42; p = 0.01). CONCLUSIONS: Micronutrient deficiencies are common in patients with severe obesity undergoing BS, especially when inflammation is present. In the presence of increased CRP values before surgery, it might be advisable to search for possible multiple micronutrient deficiencies.

Fashioning enterotomy closure after totally laparoscopic ileocolic anastomosis for right colon cancer: a multicenter experience.

BACKGROUND: Laparoscopic right hemicolectomy is a commonly performed procedure. Little is known on how to perform the enterotomy closure after stapled side-to-side intracorporeal anastomosis. METHOD: A multicentric case-controlled study has been designed to compare different ways to fashion enterotomy closure: double layer versus single layer, sewn versus stapled, and robotic versus laparoscopic approach. Furthermore, additional characteristics including sutures' materials, interrupted versus running suture and the presence of deep corner suture has been investigated. RESULTS: We collected data for 1092 patients who underwent right hemicolectomy at ten centers. We analyzed 176 robotic against 916 laparoscopic anastomosis: no significant differences were found in terms of bleedings (p = 0.455) and anastomotic leak (p = 0.405). We collected data from 126 laparoscopic sewn single-layer versus 641 laparoscopic sewn double-layer anastomosis: a significant reduction was recorded in terms of leaks in double-layer group (p = 0.02). About double-layer characteristics, we found a significant reduction of bleedings (p = 0.008) and leaks (p = 0.017) with a running suture; similarly, a reduction of bleedings (p = 0.001) and leaks (p = 0.005) was observed with the usage of deep corner closure. The presence of a barbed suture thread seemed to significantly reduce both bleedings (p = 0.001) and leaks (p = 0.001). We found no significant differences in terms of bleedings (p = 0.245) and anastomotic leak (p = 0.660) comparing sewn versus stapled anastomosis. CONCLUSIONS: Fashioning a stapled ileocolic intracorporeal anastomosis, we can recommend the adoption of a double-layer enterotomy closure using a running barbed suture in the first layer. Totally, stapled closure and robotic assistance have to be considered a non-inferior alternative.

The REAL (REctal Anastomotic Leak) score for prediction of anastomotic leak after rectal cancer surgery.

BACKGROUND: Anastomotic leak after rectal cancer surgery is a severe complication associated with poorer oncologic outcome and quality of life. Preoperative assessment of the risk for anastomotic leak is a key component of surgical planning, including the opportunity to create a defunctioning stoma. OBJECTIVE: The purpose of this study was to identify and quantify the risk factors for anastomotic leak to minimize risk by either not restoring bowel continuity or protecting the anastomosis with a temporary diverting stoma. METHODS: Potentially relevant studies were identified from the following databases: PubMed, Embase and Cochrane Library. This meta-analysis included studies on transabdominal resection for rectal cancer that reported data about anastomotic leak. The risk for anastomotic leak after rectal cancer surgery was investigated. Preoperative, intraoperative, and postoperative factors were extracted and used to compare anastomotic leak rates. All variables demonstrating a p value < 0.1 in the univariate analysis were entered into a multivariate logistic regression model to determine the risk factors for anastomotic leak. RESULTS: Twenty-six centers provided individual data on 9735 patients. Selected preoperative covariates (time before surgery, age, gender, smoking, previous abdominal surgery, BMI, diabetes, ASA, hemoglobin level, TNM classification stage, anastomotic distance) were used as independent factors in a logistic regression model with anastomotic leak as dependent variable. With a threshold value of the receiver operating characteristics (ROC) curve corresponding to 0.0791 in the training set, the area under the ROC curve (AUC) was 0.585 (p < 0.0001). Sensitivity and specificity of the model's probability > 0.0791 to identify anastomotic leak were 79.1% and 32.9%, respectively. Accuracy of the threshold value was confirmed in the validation set with 77.8% sensitivity and 35.2% specificity. CONCLUSIONS: We trust that, with further refinement using prospective data, this nomogram based on preoperative risk factors may assist surgeons in decision making. The score is now available online ( http://www.real-score.org ).

Individual participant data pooled-analysis of risk factors for recurrence after neoadjuvant radiotherapy and transanal local excision of rectal cancer: the PARTTLE study.

BACKGROUND: An organ-preserving strategy may be a valid alternative in the treatment of selected patients with rectal cancer after neoadjuvant radiotherapy. Preoperative assessment of the risk for tumor recurrence is a key component of surgical planning. The aim of the present study was to increase the current knowledge on the risk factors for tumor recurrence. METHODS: The present study included individual participant data of published studies on rectal cancer surgery. The literature was reviewed according to according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses of Individual Participant Data checklist (PRISMA-IPD) guidelines. Series of patients, whose data were collected prospectively, having neoadjuvant radiotherapy followed by transanal local excision for rectal cancer were reviewed. Three independent series of univariate/multivariate binary logistic regression models were estimated for the risk of local, systemic and overall recurrence, respectively. RESULTS: We identified 15 studies, and 7 centers provided individual data on 517 patients. The multivariate analysis showed higher local and overall recurrences for ypT3 stage (OR 4.79; 95% CI 2.25-10.16 and OR 6.43 95% CI 3.33-12.42), tumor size after radiotherapy > 10 mm (OR 5.86 95% CI 2.33-14.74 and OR 3.14 95% CI 1.68-5.87), and lack of combined chemotherapy (OR 3.68 95% CI 1.78-7.62 and OR 2.09 95% CI 1.10-3.97), while ypT3 was the only factor correlated with systemic recurrence (OR 5.93). The analysis of survival curves shows that the overall survival is associated with ypT and not with cT. CONCLUSIONS: Local excision should be offered with caution after neoadjuvant chemoradiotherapy to selected patients with rectal cancers, who achieved a good response to neoadjuvant chemoradiotherapy.

Single-incision laparoscopic cholecystectomy is responsible for increased adverse events: results of a meta-analysis of randomized controlled trials.

BACKGROUND: Over the last decade, single-incision laparoscopic cholecystectomy (SLC) has gained popularity, although it is not evident if benefits of this procedure overcome the potential increased risk. Aim of the study is to compare the outcome of SLC with conventional multi-incision laparoscopic cholecystectomy (MLC) in a meta-analysis of randomized controlled trials only. METHODS: A systematic Medline, Embase, and Cochrane Central Register of Controlled Trials literature search of articles on SLC and MLC for any indication was performed in June 2017. The main outcomes measured were overall adverse events, pain score (VAS), cosmetic results, quality of life, and incisional hernias. Linear regression was used to model the effect of each procedure on the different outcomes. RESULTS: Forty-six trials were included and data from 5141 participants were analysed; 2444 underwent SLC and 2697 MLC, respectively. Mortality reported was nil in both treatment groups. Overall adverse events were higher in the SLC group (RR 1.41; p < 0.001) compared to MLC group, as well severe adverse events (RR 2.06; p < 0.001) and even mild adverse events (RR 1.23; p = 0.041). This was confirmed also when only trials including 4-port techniques (RR 1.37, p = 0.004) or 3-port techniques were considered (RR 1.89, p = 0.020). The pain score showed a standardized mean difference (SMD) of - 0.36 (p < 0.001) in favour of SLC. Cosmetic outcome by time point scored a SMD of 1.49 (p < 0.001) in favour of SLC. Incisional hernias occurred more frequently (RR 2.97, p = 0.005) in the SLC group. CONCLUSIONS: Despite SLC offers a better cosmetic outcome and reduction of pain, the consistent higher rate of adverse events, both severe and mild, together with the higher rate of incisional hernias, should suggest to reconsider the application of single incision techniques when performing cholecystectomy with the existing technology.

Transanal Endoscopic Operation under spinal anaesthesia.

BACKGROUND: Transanal Endoscopic Operation (TEO(®) ) for rectal benign lesions and early rectal cancer may provide better oncological outcomes than flexible endoscopy. The major advantage of flexible endoscopy is that it does not require general anaesthesia. This prospective observational study assessed the feasibility and safety of TEO(®) performed under spinal anaesthesia. METHODS: The study population comprised eligible consecutive patients who underwent TEO(®) under spinal anaesthesia with curative or palliative intent for rectal neoplasms larger than 20 mm in diameter or for recurrent lesions of any size. The primary endpoints were feasibility and safety; secondary endpoints were postoperative pain, as measured on a visual analogue scale, heart rate, systolic and diastolic BP, opioid requested, postoperative nausea or vomiting, and urinary retention. RESULTS: The study included 50 patients (median age 70 years; 29 men and 21 women). No intraoperative complications occurred. The median duration of operation was 60 (range 20-165) min. No opioids were requested during the perioperative or postoperative period. The median postoperative pain score was 0 at 4, 8, 24 and 48 h after surgery. There were no significant fluctuations in heart rate, systolic and diastolic BP up to 48 h after the procedure (P = 0·379, P = 0·386 and P = 0·617 respectively). Postoperative nausea and vomiting occurred in one patient, and urinary retention in four. CONCLUSION: TEO(®) under spinal anaesthesia was safe and feasible with no conversions to general anaesthesia.

Transanal endoscopic microsurgery for giant circumferential rectal adenomas.

AIM: Transanal endoscopic microsurgery (TEM) was originally invented by Buess et al. (Chirurg, 1984, 55, 677-80) for the treatment of infraperitoneal rectal adenomas. Its indications have progressively expanded to include larger and more advanced lesions. The aim of the study was to report the results of TEM used for the treatment of circumferential rectal lesions. METHOD: We retrospectively reviewed the medical records of 17 consecutive patients [median age 69 (32-89) years; nine men] who underwent TEM for a circumferential rectal lesion in our department between September 2010 and January 2015. RESULTS: The median distance from the anal verge was 4 (3-11) cm, the median longitudinal extent was 7 (3-10) cm and the median surface area was 75 (40-255) cm(2) . An end-to-end anastomosis without proximal bowel mobilization was completed endoscopically in all cases. The median operating time was 120 (40-240) min. Persistent, endoscopically uncontrollable endoluminal bleeding in one patient was successfully treated with a second TEM procedure. One patient underwent preoperative radiotherapy for adenocarcinoma detected at the preoperative assessment. Surgical histology showed a pT3 cancer in one patient who refused further surgery, a pT2 cancer in two who subsequently underwent abdominoperineal resection, a pT1 cancer in four and a ypT0 in one patient. All are at present free of disease. No patients developed faecal incontinence or urinary or sexual dysfunction. Four patients required endoscopic balloon dilatation for stenosis. CONCLUSION: Transanal endoscopic microsurgery is a feasible and safe technique for large circumferential lesions with a satisfactory outcome. Preoperative staging may be inaccurate.

Perineal stapled prolapse resection for full-thickness external rectal prolapse: a multicentre prospective study.

AIM: Many different surgical techniques have been reported for the surgical treatment of full-thickness external rectal prolapse. Perianal stapled prolapse resection (PSP) is a relatively newly reported technique for full thickness external rectal prolapse. The aim of this prospective multicentre study was to evaluate the results of this procedure. METHOD: Consecutive patients who underwent a PSP resection for full-thickness external rectal prolapse at five centres were recruited to the study. Median operating time, hospital stay, complications, recurrence and functional results according to the Wexner Incontinence Scale and obstructive defaecation syndrome score were recorded. RESULTS: There were 27 patients treated by PSP. The median Wexner incontinence score improved from 10 presurgery to 5 after surgery (P < 0.001); the median obstructed defaecation syndrome score improved from 12 presurgery to 5 (range 4-10) after surgery (P < 0.001). A laparoscopically assisted procedure was performed in three patients (11.1%). The median number of cartridges used was six (range four to nine). The median operating time was 48 min. Early complications occurred in six patients (22.2%) and late complications in two (7.4%). The median length of hospital stay was 5 days. The recurrence rate at a median follow-up of 30.3 months was 14.8%. CONCLUSION: PSP appears to be an easy, fast and safe procedure. Early functional results are good. The recurrence rate compares favourably with other perineal procedures like the Delorme or the Altemeier operations. Long-term functional results need to be investigated further.

Acute appendicitis can be treated with single-incision laparoscopy: a systematic review of randomized controlled trials.

AIM: Single-incision laparoscopic surgery (SILS) has been proposed as the next step in minimally invasive surgery for appendicectomy. Previous reviews have summarized the results of low-evidence comparative studies, suggesting that the two approaches are comparable in terms of outcomes but showing the need for randomized controlled trials (RCTs). This review offers a meta-analyses of RCTs on this topic to evaluate the safety and efficacy of single-incision laparoscopic appendectomy (SILA). METHOD: A comprehensive research of electronic databases was performed. Primary outcomes (overall and access-specific morbidity) were designated as safety issues. Secondary outcomes were pain, cosmesis, operative time, conversion rate and length of hospital stay. RESULTS: After exclusions, five RCTs satisfied the inclusion criteria. They included a total of 761 patients [379 SILA and 382 conventional three-port laparoscopic appendectomies (CLA)]. No significant differences were found in overall morbidity, early wound morbidity or length of stay between SILA and CLA. Cosmesis and pain were not comparable due to different scales and time records. Conclusions on the incisional hernia rate were not reliable due to short follow-up periods. CONCLUSION: SILA can be considered an acceptable alternative to CLA in the treatment of acute appendicitis, but an economic evaluation of the various techniques for single access must be performed before its widespread clinical introduction. Better-designed RCTs are necessary to define a population in which SILA could have major benefits.

Randomized clinical trial comparing survival after D1 or D2 gastrectomy for gastric cancer.

BACKGROUND: It is still unclear whether D2 lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively. The aim of this multicentre randomized trial was to compare D2 and D1 lymphadenectomy in the treatment of gastric cancer. METHODS: Between June 1998 and December 2006, patients with gastric adenocarcinoma were assigned randomly to either D1 or D2 gastrectomy. Intraoperative randomization was implemented centrally by telephone. Primary outcome was overall survival; secondary endpoints were disease-specific survival, morbidity and postoperative mortality. RESULTS: A total of 267 eligible patients were allocated to either D1 (133 patients) or D2 (134) resection. Morbidity (12.0 versus 17.9 per cent respectively; P = 0.183) and operative mortality (3.0 versus 2.2 per cent; P = 0.725) rates did not differ significantly between the groups. Median follow-up was 8.8 (range 4.5-13.1) years for surviving patients and 2.4 (0.2-11.9) years for those who died, and was not different in the two treatment arms. There was no difference in the overall 5-year survival rate (66.5 versus 64.2 per cent for D1 and D2 lymphadenectomy respectively; P = 0.695). Subgroup analyses showed a 5-year disease-specific survival benefit for patients with pathological tumour (pT) 1 disease in the D1 group (98 per cent versus 83 per cent for the D2 group; P = 0.015), and for patients with pT2-4 status and positive lymph nodes in the D2 group (59 per cent versus 38 per cent for the D1 group; P = 0.055). CONCLUSION: No difference was found in overall 5-year survival between D1 and D2 resection. Subgroup analyses suggest that D2 lymphadenectomy may be a better choice in patients with advanced disease and lymph node metastases. REGISTRATION NUMBER: ISRCTN11154654 (http://www.controlled-trials.com).

Value of staging squamous cell carcinoma of the anal margin and canal using the sentinel lymph node procedure: an update of the series and a review of the literature.

BACKGROUND: Inguinal metastases in patients affected by anal cancer are an independent prognostic factor for local failure and overall mortality. Since 2001, sentinel lymph node biopsy was applied in these patients. This original study reports an update of personal and previous published series, which were compared with Literature to value the incidence of inguinal metastases T-stage related and the overall incidence of false negative inguinal metastases at sentinel node. METHODS: In all, 63 patients diagnosed with anal cancer submitted to inguinal sentinel node. Furthermore a research in the Pub Med database was performed to find papers regarding this technique. RESULTS: In our series, detection rate was 98.4%. Inguinal metastases were evidentiated in 13 patients (20.6%). Our median follow-up was 35 months. In our series, no false negative nodes were observed. CONCLUSION: Sentinel node technique in the detection of inguinal metastases in patients affected by anal cancer should be considered as a standard of care. It is indicated for all T stages in order to select patients to be submitted to inguinal radiotherapy, avoiding related morbidity in negative ones. An overall 3.7% rate of false negative must be considered acceptable.

A novel biomarker-based analysis reliably predicts nodal metastases in anal carcinoma: preliminary evidence of therapeutic impact.

AIM: Routine prophylactic inguinal irradiation in anal cancer may cause significant toxicity associated with overtreatment bias. The aim of this study was to determine the risk of regional node metastases in anal carcinoma by identifying predictive molecular biomarkers. METHOD: Clinicohistopathological data from 50 pretreatment anal carcinoma biopsies were collected. Immunohistochemical analyses with antibodies against Ki67, p53, epidermal growth factor receptor (EGFR) and YKL-40 were performed. Statistical correlations between biomarkers and clinicopathological features and outcomes were studied. Sentinel lymph node biopsy was performed in a subset of 36 patients. RESULTS: All patients had undergone synchronous radiochemotherapy; tumour recurrence had developed in 26%, and 16% had died. YKL-40 tumour expression correlated with lymph node metastasis, whereas no inguinal node metastases were found in any of the (14%) patients presenting with a YKL-40/EGFR-negative tumour. YKL-40 expression and node metastasis were both significantly associated with shorter overall and disease-free survival. Tumour grade significantly correlated with disease-free survival only. HIV, tumour histological type, Ki67, p53 and EGFR were not associated with outcome. CONCLUSION: YKL-40 expression in anal carcinoma is correlated with a poor outcome and can predict lymph node metastases. The combined absence of YKL-40 and EGFR expression in a first biopsy of anal carcinoma reliably selects a subset of patients without inguinal metastases. Such patients could be spared sentinel lymph node biopsy and/or inguinal radiotherapy.

Transanal endoscopic microsurgery.

The aim of oncologic surgery is radical cancer treatment with preservation of function and quality of life. Almost 30 years ago, transanal endoscopic microsurgery (TEM) revolutionised the technique and outcomes of transanal surgery, first becoming the standard of treatment for large rectal adenomas, then offering a possibly curative treatment for early rectal cancer, and finally generating discussion on its potential role in combination with neoadjuvant therapies for the treatment of more invasive cancer. TEM afforded the advantage of combining a less invasive transanal approach with low recurrence rates thanks to enhanced visualization of the surgical field, which allows more precise dissection. We describe the current indications, the preoperative work-up, the surgical technique (with the aid of a video), postoperative management and results obtained in an over 20-year-long experience. Designed as an accurate means to allow excision of benign rectal neoplasms with a very low morbidity rate, TEM today is indicated as a curative treatment of malignant neoplasms that are histologically confirmed as pT1 sm1 carcinomas. T1 sm2-3 and T2 lesions should at present be included in prospective trials. Accurate preoperative staging is essential for optimal selection of patients. Patients with clear indication for TEM should be referred to specialized medical centres experienced with the technique.

Magnetic air capsule robotic system: proof of concept of a novel approach for painless colonoscopy.

BACKGROUND: Despite being considered the most effective method for colorectal cancer diagnosis, colonoscopy take-up as a mass-screening procedure is limited mainly due to invasiveness, patient discomfort, fear of pain, and the need for sedation. In an effort to mitigate some of the disadvantages associated with colonoscopy, this work provides a preliminary assessment of a novel endoscopic device consisting in a softly tethered capsule for painless colonoscopy under robotic magnetic steering. METHODS: The proposed platform consists of the endoscopic device, a robotic unit, and a control box. In contrast to the traditional insertion method (i.e., pushing from behind), a "front-wheel" propulsion approach is proposed. A compliant tether connecting the device to an external box is used to provide insufflation, passing a flexible operative tool, enabling lens cleaning, and operating the vision module. To assess the diagnostic and treatment ability of the platform, 12 users were asked to find and remove artificially implanted beads as polyp surrogates in an ex vivo model. In vivo testing consisted of a qualitative study of the platform in pigs, focusing on active locomotion, diagnostic and therapeutic capabilities, safety, and usability. RESULTS: The mean percentage of beads identified by each user during ex vivo trials was 85 ± 11%. All the identified beads were removed successfully using the polypectomy loop. The mean completion time for accomplishing the entire procedure was 678 ± 179 s. No immediate mucosal damage, acute complications such as perforation, or delayed adverse consequences were observed following application of the proposed method in vivo. CONCLUSIONS: Use of the proposed platform in ex vivo and preliminary animal studies indicates that it is safe and operates effectively in a manner similar to a standard colonoscope. These studies served to demonstrate the platform's added advantages of reduced size, front-wheel drive strategy, and robotic control over locomotion and orientation.