CLASSICA: Validating artificial intelligence in classifying cancer in real time during surgery.

AIM: Treatment pathways for significant rectal polyps differ depending on the underlying pathology, but pre-excision profiling is imperfect. It has been demonstrated that differences in fluorescence perfusion signals following injection of indocyanine green (ICG) can be analysed mathematically and, with the assistance of artificial intelligence (AI), used to classify tumours endoscopically as benign or malignant. This study aims to validate this method of characterization across multiple clinical sites regarding its generalizability, usability and accuracy while developing clinical-grade software to enable it to become a useful method. METHODS: The CLASSICA study is a prospective, unblinded multicentre European observational study aimed to validate the use of AI analysis of ICG fluorescence for intra-operative tissue characterization. Six hundred patients undergoing transanal endoscopic evaluation of significant rectal polyps and tumours will be enrolled in at least five clinical sites across the European Union over a 4-year period. Video recordings will be analysed regarding dynamic fluorescence patterns centrally as software is developed to enable analysis with automatic classification to happen locally. AI-based classification and subsequently guided intervention will be compared with the current standard of care including biopsies, final specimen pathology and patient outcomes. DISCUSSION: CLASSICA will validate the use of AI in the analysis of ICG fluorescence for the purposes of classifying significant rectal polyps and tumours endoscopically. Follow-on studies will compare AI-guided targeted biopsy or, indeed, AI characterization alone with traditional biopsy and AI-guided local excision versus traditional excision with regard to marginal clearance and recurrence.

Increasing Operating Room Efficiency with Shop Floor Management: an Empirical, Code-Based, Retrospective Analysis.

With increasing economic pressure on health care, modern hospital management is focusing at industrial optimization techniques to improve efficiency while maintaining quality. Shop floor management, a technique of code-based, process-oriented guidance directly on site is a method of lean management intended to increase efficiency in the operating room. In the literature, there is only scant evidence that the introduction of this technique alone can increase efficiency. The aim of this retrospective study is to determine whether a single tool alone can significantly improve codes. We performed an empirical, retrospective analysis of a number of codes from 3800 operations during two periods of comparison: upon introduction of shop floor management, and one year thereafter. Data was extracted from the Hospital Information System and transferred to a database. There was no statistically significant change in the relevant codes chosen, whether specific to the operating room (turnover time, first patient in the room, waiting times for anesthesia and surgery (p = 0.637) or to planning stability (scheduled, cancelled (p = 0.505), unscheduled and total operations performed (p = 0.984)). There were absolute changes, such as a reduction in the turnover time from 17:37 min to 16:26 min, even though not statistically significant (p = 0.238). Implementation of shop floor management as a single intervention is not appropriate to achieve a significant, continuous improvement in codes. A combination with other techniques such as detailed process analyses is definitely required. This could be important additional information for units using Lean Health Care strategies.

[Transanal total mesorectal excision-Indications, technique and results]. / Transanale totale mesorektale Exzision ­ Indikation, Technik, Ergebnisse.

Total mesorectal excision (TME) has become the standard treatment for rectal cancer in the middle and lower third. Meanwhile, many international trials have confirmed the noninferiority of laparoscopic TME compared to the open technique. Nevertheless, in the presence of anatomical limitations, such as narrow, obese, male pelvises as well as large rectal tumors, the adequate resection of the lower third of the rectum according to oncological criteria, is still challenging even for specialized colorectal surgeons. Therefore, the implementation of innovative approaches, such as robotic-assisted and transanal TME (TaTME) should shed light on this anatomically complex region and guarantee an oncological radical resection and the best possible preservation of neural structures. The advantages of this technique have so far only been provided by retrospective cohort studies by large international centers. Therefore, international prospective randomized trials are currently recruiting patients to analyze the surgical and oncological outcome of TaTME compared to conventional techniques. This article describes the TaTME technique per se, the fields of application and the current data situation. Practical recommendations for the safe implementation of this operative procedure are also presented. The TaTME procedure is reserved for highly specialized colorectal centers with a high volume of rectal cancer cases and appropriate expertise in minimally invasive visceral surgery.Die totale mesorektale Exzision (TME) ist der Goldstandard im Kontext der multimodalen Behandlung des Rektumkarzinoms im mittleren und unteren Drittel. Der transanale Zugang ist eine Ergänzung des zunehmend laparoskopischen Vorgehens, welcher gerade bei anatomischen Limitationen bei der onkologisch adäquaten Resektion des distalen Rektums Abhilfe schaffen soll. Die Nichtunterlegenheit in chirurgischen und onkologischen Parametern wird gegenüber konventionellen (laparoskopisch/offen) Operationsmethoden derzeit intensiv beforscht. Eine sichere Implementation dieser herausfordernden Technik ist an ein modulares Trainingskurrikulum gebunden.

Anastomotic leak after transanal total mesorectal excision: grading of severity and management aimed at preservation of the anastomosis.

AIM: The transanal approach to total mesorectal excision (TaTME) as an alternative to conventional anterior resection offers an improved view to otherwise restricted anatomical regions in obese and narrow male pelves and unfavourable tumour locations. Guidelines for the management of anastomotic leakage (AL) following low rectal resections are scarce. PATIENTS AND METHODS: Prospectively collected data of all consecutive patients undergoing TaTME between December 2014 and April 2017 in our centre were analysed retrospectively. Existing classification systems for AL were modified with regard to transanal anastomotic-preserving management. RESULTS: TaTME was performed in 66 patients with a median age of 56.2 years. The overall incidence of AL was 12.1% (n = 8). AL grading was differentiated in Grades I to V according to the severity of necrosis and abscess development. Two patients suffered from AL Grade II, one patient from Grade III, three patients from Grade IV and two patients from Grade V. Preservation of the anastomosis following AL was achieved by the damage control concept in six of eight patients (75%) with a median duration of hospital stay of 36 days. Two patients received a Hartmann procedure (Grades IV and V). CONCLUSION: Our study demonstrates that management of AL following TaTME is challenging but definitely amenable to strategies aimed at preserving the anastomosis by appropriate damage control. The modified classification system might serve as guidance for anastomosis-preserving management.

[Assessment of individualized treatment of rectal carcinoma]. / Bewertung der individualisierten Therapie des Rektumkarzinoms.

Individualized and tailored treatment plays a crucial role in the rating of special operation techniques or certain treatment strategies following defined quality criteria and indicators. Deviations from clearly defined recommendations in guidelines must therefore be justified, documented and evaluated as precisely as possible. The aim of this leading article is to examine the individualized treatment of rectal cancer based on existing evidence and to discuss its role in the light of routinely used treatment algorithms. In addition to a web-based literature search the current German national S3 guidelines on colorectal cancer were also included. In the treatment of cancer in the middle and lower third of the rectum, individual, patient and tumor-related parameters are of decisive importance from the pretreatment stage to the actual surgery up to aftercare and adjuvant therapy to enable interdisciplinary decision making for optimal treatment.

The adipofasciocutaneous gluteal fold perforator flap a versatile alternative choice for covering perineal defects.

AIM: Perineal defects following the resection of anorectal malignancies are a reconstructive challenge. Flaps based on the rectus abdominis muscle have several drawbacks. Regional perforator flaps may be a suitable alternative. We present our experience of using the gluteal fold flap (GFF) for reconstructing perineal and pelvic defects. METHODS: We used a retrospective chart review and follow-up examinations focusing on epidemiological, oncological (procedure and outcome), and therapy-related data. This included postoperative complications and their management, length of hospital stay, and time to heal. RESULTS: Twenty-two GFFs (unilateral n = 8; bilateral n = 7) were performed in 15 patients (nine women and six men; anal squamous cell carcinoma n = 8; rectal adenocarcinoma n = 7; mean age 65.5 + 8.2 years) with a mean follow-up time of 1 year. Of the cases, 73.3% were a recurrent disease. Microscopic tumor resection was achieved in all but one case (93.3%). Seven cases had no complications (46.7%). Surgical complications were classified according to the Clavien-Dindo system (grades I n = 2; II n = 2; IIIb n = 4). These were mainly wound healing disorders that did not affect mobilization or discharge. The time to discharge was 22 + 9.9 days. The oncological outcomes were as follows: 53.3% of the patients had no evidence of disease, 20% had metastatic disease, 20% had local recurrent disease, and one patient (6.7%) died of other causes. CONCLUSIONS: The GFF is a robust, reliable flap suitable for perineal and pelvic reconstruction. It can be raised quickly and easily, has an acceptable complication rate and donor site morbidity, and does not affect the abdominal wall.

Perforated Diverticulitis with Generalized Peritonitis: Low Stoma Rate Using a "Damage Control Strategy".

PURPOSE: Optimal surgical management of perforated diverticulitis of the sigmoid colon has yet to be clearly defined. The purpose of this study was to evaluate efficacy of a "Damage Control Strategy" (DCS). MATERIALS AND METHODS: Patients with perforated diverticulitis of the sigmoid colon complicated by generalized peritonitis (Hinchey III and IV) surgically treated according to a damage control strategy between May 2011 and February 2017 were enrolled in the present multicenter retrospective cohort study. Data were collected at three surgical centers. DCS comprises a two-stage concept: [1] limited resection of the perforated colon segment with oral and aboral blind closure during the emergency procedure and [2] definitive reconstruction at scheduled second laparotomy (anastomosis ∓ loop ileostomy or a Hartmann's procedure) after 24-48 h. RESULTS: Fifty-eight patients were included into the analysis [W:M 28:30, median age 70.1 years (30-92)]. Eleven patients (19%) initially presented with fecal peritonitis (Hinchey IV) and 47 patients with purulent peritonitis (Hinchey III). An anastomosis could be created during the second procedure in 48 patients (83%), 14 of those received an additional loop ileostomy. In the remaining ten patients (n = 17%), an end colostomy was created at second laparotomy. A fecal diversion was performed in five patients to treat anastomotic complications. Thus, altogether, 29 patients (50%) had stoma at the end of the hospital stay. The postoperative mortality was 9% (n = 5), and median postoperative hospital stay was 18.5 days (3-66). At the end of the follow-up, 44 of 53 surviving patients were stoma free (83%). CONCLUSION: The use of the Damage Control strategy leads to a comparatively low stoma rate in patients suffering from perforated diverticulitis with generalized peritonitis.

Damage control surgery in perforated diverticulitis: ongoing peritonitis at second surgery predicts a worse outcome.

PURPOSE: Damage control strategy (DCS) is a two-staged procedure for the treatment of perforated diverticular disease complicated by generalized peritonitis. The aim of this retrospective multicenter cohort study was to evaluate the prognostic impact of an ongoing peritonitis at the time of second surgery. METHODS: Consecutive patients who underwent DCS for perforated diverticular disease of the sigmoid colon with generalized peritonitis at four surgical centers were included. Damage control strategy is a two-stage emergency procedure: limited resection of the diseased colonic segment, closure of oral and aboral colon, and application of a negative pressure assisted abdominal closure system at the initial surgery followed by second laparotomy 48 h later. Therein, decision for definite reconstruction (anastomosis or Hartmann's procedure (HP)) is made. An ongoing peritonitis at second surgery was defined as presence of visible fibrinous, purulent, or fecal peritoneal fluid. Microbiologic findings from peritoneal smear at first surgery were collected and analyzed. RESULTS: Between 5/2011 and 7/2017, 74 patients underwent a DCS for perforated diverticular disease complicated by generalized peritonitis (female: 40, male: 34). At second surgery, 55% presented with ongoing peritonitis (OP). Patients with OP had higher rate of organ failure (32 vs. 9%, p = 0.024), higher Mannheim Peritonitis Index (25.2 vs. 18.9; p = 0.001), and increased operation time (105 vs. 84 min., p = 0.008) at first surgery. An anastomosis was constructed in all patients with no OP (nOP) at second surgery as opposed to 71% in the OP group (p < 0.001). Complication rate (44 vs. 24%, p = 0.092), mortality (12 vs. 0%, p = 0.061), overall number of surgeries (3.4 vs. 2.4, p = 0.017), enterostomy rate (76 vs. 36%, p = 0.001), and length of hospital stay (25 vs. 18.8 days, p = 0.03) were all increased in OP group. OP at second surgery occurred significantly more often in patients with Enterococcus infection (81 vs. 44%, p = 0.005) and with fungal infection (100 vs. 49%, p = 0.007). In a multivariate analysis, Enterococcus infection was associated with increased morbidity (67 vs. 21%, p < 0.001), enterostomy rate (81 vs. 48%, p = 0.017), and anastomotic leakage (29 vs. 6%, p = 0.042), whereas fungal peritonitis was associated with an increased mortality (43 vs. 4%, p = 0.014). CONCLUSION: Ongoing peritonitis after DCS is a predictor of a worse outcome in patients with perforated diverticulitis. Enterococcal and fungal infections have a negative impact on occurrence of OP and overall outcome.

[Ultrasonography of the prostate gland : From B­image through multiparametric ultrasound to targeted biopsy]. / Ultraschall der Prostata : Vom B­Bild über den multiparametrischen Ultraschall zur gezielten Biopsie.

BACKGROUND: Prostate cancer is the most frequent cancer in men. The diagnosis is normally achieved by a systematic prostate biopsy; however, this is a randomized approach by which a substantial number of significant carcinomas go undetected. For this reason, in recent years imaging techniques have been continuously developed, which enable visualization and therefore targeted biopsies. STANDARD PROCEDURE: The use of systematic biopsies is a standard procedure for the detection of prostate cancer. The quality of biopsies can be increased if the prostate is examined for the presence of suspected cancerous alterations during the biopsy. This can be carried out using multiparametric transrectral ultrasound. PERFORMANCE: Multiparametric ultrasound within the framework of a targeted biopsy increases the detection rate of significant prostate carcinomas with a simultaneous decrease in detection of insignificant carcinomas; however, the diagnostic reliability and the evidence level of multiparametric transrectal ultrasound are not yet sufficiently high to be able to replace a systematic biopsy. CONCLUSION: In the hands of a well-trained examiner multiparametric transrectal ultrasound represents a good method for detection of prostate carcinomas. With the progression in technical developments of ultrasound technology, the detection rate will presumably be further increased.

Conservative management of distal leg necrosis in lung transplant recipients.

Critical limb ischemia (CLI) with distal leg necrosis in lung transplant recipients (LTR) is associated with a high risk for systemic infection and sepsis. Optimal management of CLI has not been defined so far in LTR. In immunocompetent individuals with leg necrosis, surgical amputation would be indicated and standard care. We report on the outcome of four conservatively managed LTR with distal leg necrosis due to peripheral arterial disease (PAD) with medial calcification of the distal limb vessels. Time interval from lung transplantation to CLI ranged from four years (n = 1) to more than a decade (n = 3). In all cases a multimodal therapy with heparin, acetylsalicylic acid, iloprost and antibiotic therapy was performed, in addition to a trial of catheter-based revascularization. Surgical amputation of necrosis was not undertaken due to fear of wound healing difficulties under long-term immunosuppression and impaired tissue perfusion. Intensive wound care and selective debridement were performed. Two patients developed progressive gangrene followed by auto-amputation during a follow-up of 43 and 49 months with continued ambulation and two patients died of unrelated causes 9 and 12 months after diagnosis of CLI. In conclusion, we report a conservative treatment strategy for distal leg necrosis in LTR without surgical amputation and recommend this approach based on our experience.

[Training course transanal total mesorectal excision (TaTME) : Concept and establishment of a training course for safe application]. / Trainingskurs transanale totale mesorektale Exzision (TaTME) : Konzept und Realisation eines Trainingskurses zur sicheren Anwendung.

BACKGROUND: In recent years the video endoscopy-assisted transanal approach to total mesorectal excision (TME) combined with the conventional laparoscopic technique was developed as an alternative indication for treatment of low rectal cancer (TaTME). OBJECTIVE: The concept and results of the first German TaTME hands-on cadaver course with subsequent live surgery are presented. MATERIAL AND METHODS: The 2­day training course was structured into an anatomical and a clinical surgery part. The participants could learn from basics to live surgery and shared their experiences during presentations about currently available data, rationale and technique of TaTME with special emphasis on technical failures and pitfalls. The supervised simulator training and TaTME exercises at three cadaver work stations were proctored by experienced surgeons. On day 2 the participants observed two cases of TaTME at the moderated live surgery session. RESULTS: The step-up learning curve for the transanal approach could be clearly observed in each team from warm-up to hands-on training sessions. In the practical session the participants could train the milestones of the transanal approach on cadavers, including the pitfalls. Finally, the participants observed live surgery on two patients with low rectal tumors on day 2 of the course. CONCLUSION: A step-up training course on cadavers is indispensable regarding implementation of techniques, such as TaTME into clinical practice. Coordinated clinical guest demonstrations provide translation of theoretical basic principles and practical skills from the cadaver course to real patient treatment. Participants should be encouraged to report their cases to registered trials or registries.

Results of the Gore Bio-A fistula plug implantation in the treatment of anal fistula: a multicentre study.

BACKGROUND: The aim of this prospective study was to determine the efficiency of the Gore Bio-A synthetic plug in the treatment of anal fistulas. METHODS: A synthetic bioabsorbable anal fistula plug was implanted in 60 patients. All fistulas were transsphincteric and cryptoglandular in origin. RESULTS: The healing rate after 1 year of follow-up was 52 % (31 out of 60 patients). No patient was lost to follow-up. The treatment had no effect on the incontinence score. The plug dislodgement rate was 10 % (6 out of 60 patients). Thirty-four per cent of the patients (16 out of 47) required reoperation. The average operating time was 32 ± 10.2 min, and the average length of hospital stay was 3.3 ± 1.8 days. CONCLUSIONS: Synthetic plugs may be an alternative to bioprosthetic fistula plugs in the treatment of transsphincteric anal fistulas. This method might have better success rates than treatment with bioprosthetic fistula plugs.

Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial.

AIM: Novel minimally invasive techniques aimed to reposition the haemorrhoidal zone have been established for prolapsing haemorrhoids. We present a prospective randomized controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries (DG-HAL) in patients with symptomatic Grade III haemorrhoids. The trial was registered as ClinicalTrials.gov identifier NCT02372981. METHOD: All consecutive patients with symptomatic Grade III haemorrhoids were randomly allocated to one of the two study arms: (i) Group A, DG-HAL with mucopexy or (ii) Group B, mucopexy alone. End-points were postoperative pain, faecal incontinence, bleeding, residual prolapse and alterations of the vascularization of the anorectal vascular plexus. Vascularization of the anorectal vascular plexus was assessed by transperineal contrast enhanced ultrasound. Patients recorded their symptoms in a diary maintained for a month. RESULTS: Forty patients were recruited and randomized to the two study groups. Patients in Group A had less pain in the first two postoperative weeks. At the 12-month follow-up, two patients in Group A (10%) and one in Group B (5%) showed recurrent Grade III haemorrhoids (P = 0.274). No significant morphological changes were observed in the transperineal ultrasound findings between the preoperative assessment and the assessment at 1 and 6 months in either group (P > 0.05). CONCLUSION: Mucopexy techniques for treating prolapsing haemorrhoids are effective, but DG-HAL does not add significantly to the results achieved by mucopexy. Repositioning the haemorrhoidal zone is the key to success, and mucopexy should be placed at the sites of the largest visible prolapse.

Strain Elastography of Breast and Prostata Cancer: Similarities and Differences.

UNLABELLED: Typically both breast and prostate cancer present as tissue with decreased elasticity. Palpation is the oldest technique of tumor detection in both organs and is based on this principle. Thus an operator can grade a palpable mass as suspicious for cancer. Strain elastography as modern ultrasound technique allows the visualization of tissue elasticity in a color coded elastogram and can be understood as technical finger. The following article shows similarities and differences of ultrasound strain elastography in the diagnosis of breast and prostate cancer. KEY POINTS: • In prostata cancer elastography, in breast cancer B-mode is the primary sonographic search modality. • The diagnostic value of the search modalities change with increasing age.• A cut-off value for a strain ratio is hard to obtain in the elastography of the prostata, because there is no stabile reference tissue in the prostata.

[Bevacizumab as first-line therapy in metastatic renal cell carcinoma: Progression-free survival for 3 years]. / Metastasiertes Nierenzellkarzinom unter Bevacizumab als Erstlinientherapie : Progressionsfreies Überleben seit 3 Jahren.

We report the case of a 72-year-old woman who was diagnosed in 2006 with renal cell cancer (RCC) and had undergone consecutive tumor nephrectomy (clear-cell RCC, Fuhrmann grade II, stage pT3a, R0). Over the years, the patient underwent several surgical and radiological interventions due to various metastatic lesions. This case report describes the 3-year progression-free survival in a patient who underwent first-line therapy with the monoclonal antibody bevacizumab. Except for hypertension, the patient does not suffer currently from any other side effects of bevacizumab therapy.

Exogenous Lipocalin 2 Ameliorates Acute Rejection in a Mouse Model of Renal Transplantation.

Lipocalin 2 (Lcn2) is rapidly produced by damaged nephron epithelia and is one of the most promising new markers of renal injury, delayed graft function and acute allograft rejection (AR); however, the functional importance of Lcn2 in renal transplantation is largely unknown. To understand the role of Lcn2 in renal AR, kidneys from Balb/c mice were transplanted into C57Bl/6 mice and vice versa and analyzed for morphological and physiological outcomes of AR at posttransplantation days 3, 5, and 7. The allografts showed a steady increase in intensity of interstitial infiltration, tubulitis and periarterial aggregation of lymphocytes associated with a substantial elevation in serum levels of creatinine, urea and Lcn2. Perioperative administration of recombinant Lcn2:siderophore:Fe complex (rLcn2) to recipients resulted in functional and morphological amelioration of the allograft at day 7 almost as efficiently as daily immunosuppression with cyclosporine A (CsA). No significant differences were observed in various donor-recipient combinations (C57Bl/6 wild-type and Lcn2(-/-) , Balb/c donors and recipients). Histochemical analyses of the allografts showed reduced cell death in recipients treated with rLcn2 or CsA. These results demonstrate that Lcn2 plays an important role in reducing the extent of kidney AR and indicate the therapeutic potential of Lcn2 in transplantation.