Comment on Pata et al. Sclerobanding (Combined Rubber Band Ligation with 3% Polidocanol Foam Sclerotherapy) for the Treatment of Second- and Third-Degree Hemorrhoidal Disease: Feasibility and Short-Term Outcomes. J. Clin. Med. 2022, 11, 218.

Dr. Pata kindly tweeted the publication of the above-mentioned paper [...].

Genome-wide analysis of 944 133 individuals provides insights into the etiology of haemorrhoidal disease.

OBJECTIVE: Haemorrhoidal disease (HEM) affects a large and silently suffering fraction of the population but its aetiology, including suspected genetic predisposition, is poorly understood. We report the first genome-wide association study (GWAS) meta-analysis to identify genetic risk factors for HEM to date. DESIGN: We conducted a GWAS meta-analysis of 218 920 patients with HEM and 725 213 controls of European ancestry. Using GWAS summary statistics, we performed multiple genetic correlation analyses between HEM and other traits as well as calculated HEM polygenic risk scores (PRS) and evaluated their translational potential in independent datasets. Using functional annotation of GWAS results, we identified HEM candidate genes, which differential expression and coexpression in HEM tissues were evaluated employing RNA-seq analyses. The localisation of expressed proteins at selected loci was investigated by immunohistochemistry. RESULTS: We demonstrate modest heritability and genetic correlation of HEM with several other diseases from the GI, neuroaffective and cardiovascular domains. HEM PRS validated in 180 435 individuals from independent datasets allowed the identification of those at risk and correlated with younger age of onset and recurrent surgery. We identified 102 independent HEM risk loci harbouring genes whose expression is enriched in blood vessels and GI tissues, and in pathways associated with smooth muscles, epithelial and endothelial development and morphogenesis. Network transcriptomic analyses highlighted HEM gene coexpression modules that are relevant to the development and integrity of the musculoskeletal and epidermal systems, and the organisation of the extracellular matrix. CONCLUSION: HEM has a genetic component that predisposes to smooth muscle, epithelial and connective tissue dysfunction.

Learning Laparoscopic Surgery Skills With a 4K Ultra-High Definition 2D vs a Three-Dimensional HD Laparoscopic System: Results From a Prospective Randomized Trial.

Background. In minimally invasive surgery (MIS), the loss of stereoscopic depth perception in a two-dimensional (2D) representation is most challenging. Recently introduced 4K ultrahigh definition (UHD) 2D optical systems could potentially facilitate the learning and use of compensation mechanisms for the loss of depth perception. However, the role of the new 4K technology against three dimensional (3D) in learning and implementation of MIS remains unknown. The aim of this trial was to determine the influence of 4K UHD 2D vs 3D HD representation on the acquisition of MIS skills. Methods. This was a prospective randomized study involving 62 MIS-inexperienced study participants. We compared a laparoscopic 4K UHD 2D (system A) vs a laparoscopic 3D HD system (system B) for differences in learning MIS skills using the Lübeck Toolbox (LTB) video box trainer. We evaluated participants' performance regarding the repetitions required to reach the goal of each LTB task. Results. Comparing systems A and B, participants using the laparoscopic 3D system required fewer repetitions to achieve goals of LTB tasks No. 1 (P = .0048) and No. 3 (P = .0014). In contrast, for LTB tasks No. 2 and No. 4, no significant difference could be determined between both groups. Conclusion. Our results indicated that MIS basic skills can be learned quicker using a 3D HD system vs a 4K UHD 2D system. However, for MIS tasks in confined spaces, the learning speed with 4K UHD 2D imaging seems to be comparable to a 3D HD system.

Erratum to "Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE)" [Int. J. Surg. Protoc. 21 (2020) 13-20].

[This corrects the article DOI: 10.1016/j.isjp.2020.02.004.].

Testing Distinct Three-Dimensional Effects in Laparoscopy: A Prospective Randomized Trial Using the Lübecker Toolbox Curriculum.

BACKGROUND: The use of stereoscopic laparoscopic systems in minimally invasive surgery (MIS) allows a three-dimensional (3D) view of the surgical field, which improves hand-eye coordination. Depending on the stereo base used in the construction of the endoscopes, 3D systems may differ regarding the 3D effect. Our aim was to investigate the influence of different stereo bases on the 3D effect. METHODS: This was a prospective randomized study involving 42 MIS-inexperienced study participants. We evaluated two laparoscopic 3D systems with stereo bases of 2.5 mm (system A) and 3.8 mm (system B) for differences in learning MIS skills using the Lübeck Toolbox (LTB) video box trainer. We evaluated participants' performance regarding the times and repetitions required to reach each exercise's goal. After completing the final exercise ("suturing"), participants performed the exercise again using a two-dimensional (2D) representation. Additionally, we retrospectively compared our study results with a preliminary study from participants completing the LTB curriculum with a 2D system. RESULTS: The median number of repetitions until reaching the goals for LTB exercises 1, 2, 3, and 6 for system A were: 18 (range 7-53), 24 (range 8-46), 24 (range 13-51), and 21 (range 10-46), respectively, and for system B were: 12 (range 2-30), 16 (range 6-43), 17 (range 4-47), and 15 (range 6-29), respectively (p = not significant). Changing from a 3D to a 2D representation after completing the learning curve led to a longer average time required, from 95.22 to 119.3 s (p < 0.0001), for the last exercise (exercise 6; "suturing"). When comparing the results retrospectively with the learning curves acquired with the 2D system, there was a significant reduction in the number of repetitions required to reach the LTB exercise goals for exercises 1, 3, and 6 using the 3D system. CONCLUSION: Stereo bases of 2.5 and 3.8 mm provide acceptable bases for designing 3D systems. Additionally, our results indicated that MIS basic skills can be learned quicker using a 3D system versus a 2D system, and that when the 3D effect is eliminated, the corresponding compensatory mechanisms must be relearned.

Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE).

BACKGROUND: Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents' skills in performing their first MIS procedures on patients. METHOD: The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the Lübeck Toolbox curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint). DISCUSSION: The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.

[Surgical Management of Advanced Haemorrhoid Disease - What's the Deal?] / Operative Verfahrenswahl beim fortgeschrittenen Hämorrhoidalleiden ­ worauf kommt es an?

About 2 - 3 million patients suffer from haemorrhoid disease in Germany each year. Advanced haemorrhoid disease is assumed if an operation is planned. In Germany, approximately 50,000 operations per year are performed for haemorrhoids. Individual therapy and surgery are implemented after proctological examination. A wide variety of surgical procedures are available. These techniques will be described and illustrated. Individual comorbidities such as anticoagulation and will be discussed, together with options for teaching these surgical skills - in times of difficult recruitment.

Video Tutorials Increase Precision in Minimally Invasive Surgery Training - a Prospective Randomised Trial and Follow-up Study. / Video-Tutorials erhöhen die Präzision im minimalinvasiven Operationstraining ­ eine prospektiv randomisierte Studie und Nachuntersuchung.

BACKGROUND: Simulation-based practice has become increasingly important in minimally invasive surgery (MIS) training. Nevertheless, personnel resources for demonstration and mentoring simulation-based practice are limited. Video tutorials could be a useful tool to overcome this dilemma. However, the effect of video tutorials on MIS training and improvement of MIS skills is unclear. METHODS: A prospective randomised trial (n = 24 MIS novices) was conducted. A video-trainer with three different tasks (#1 - 3) was used for standardised goal-directed MIS training. The subjects were randomised to two groups with standard instructional videos (group A, n = 12) versus comprehensive video tutorials for each training task watched at specific times of repetition (group B, n = 12). Performance was analysed using the MISTELS score. At the beginning and following the curriculum, an MIS cholecystectomy (CHE) was performed on a porcine organ model and analysed using the GOALS score. After 18 weeks, participants performed 10 repetitions of tasks #1 - 3 for follow-up analysis. RESULTS: More participants completed tasks #1 and #2 in group B (83.3 and 75%) than in group A (66.7 and 50%, ns). For task #2, there was a significant improvement in precision in group B (p < 0.001). For the entire cohort, the GOALS-Scores were 12.9 before and 18.9 after the curriculum (p < 0.001), with no significant difference between groups. Upon follow-up, 84.2% (task#1), 26.3% (task#2) and 100% (task#3) of MIS novices were able to reach the defined goals (A vs. B ns). There was a trend for a better MISTELS score in group B upon follow-up. CONCLUSIONS: Standardised comprehensive video tutorials watched frequently throughout practice can significantly improve precision in MIC training. This aspect should be incorporated in MIS training.

Influence of Anastomotic Leak After Elective Colorectal Cancer Resection on Survival and Local Recurrence: A Propensity Score Analysis.

BACKGROUND: The occurrence of anastomotic leakage is still a life-threatening complication for patients after colorectal surgery. In literature not only an impact on the short-term outcome but also on long-term survival and local recurrence of colorectal cancer patients is discussed. OBJECTIVE: This study aimed to investigate the impact of anastomotic leakage on long-term survival and local recurrence. DESIGN: A total of 1122 patients with resections for colorectal cancer were analyzed. In 94 patients (8.4%) there was clinical proof of anastomotic leakage. A reference group was defined as the 1028 patients without anastomotic leakage using 1:1 propensity score-matching according to the following criteria: age, sex, International Union Against Cancer stage, Karnofsky index, tumor site, and grading, as well as adjuvant chemotherapy. A calculation of overall survival, disease-free survival, and local recurrence rate was performed for both groups. SETTINGS: The study was conducted using a retrospective matched-pairs analysis, based on a prospectively maintained institutional colorectal cancer database. PATIENTS: Ninety-four patients with anastomotic leakage and 94 matched control subjects from a total of 1122 patients with resections for colorectal cancer were studied. MAIN OUTCOME MEASURES: Overall survival, disease-free survival, and local recurrence rate for patients with colorectal cancer with and without anastomotic leakage were measured. RESULTS: The propensity score matching successfully created 2 groups with no significant differences in the matching criteria. Survival analysis disclosed no significant differences between the groups in terms of overall survival, disease-free survival, and local recurrence rate. Univariate analysis identified age, Karnofsky index, International Union Against Cancer stage, and lymph node metastasis as significant prognostic factors. Multivariable analysis of these variates revealed age and positive lymph nodes as independent predictors of overall survival and disease-free survival. LIMITATIONS: The study was limited by nature of being a retrospective analysis and monocentric study. CONCLUSIONS: This matched-pairs analysis, comparing patients with colorectal cancer with and without anastomotic leakage, revealed no significant differences in overall survival, disease-free survival, and local recurrence rate. Contrary results in the literature might be caused by nonbalanced settings in nonmatched collectives. See Video Abstract at http://links.lww.com/DCR/A811.

Conception of the Lübeck Toolbox curriculum for basic minimally invasive surgery skills.

PURPOSE: Difficulties at the beginning of the learning curve in minimally invasive surgery (MIS) can well be overcome by simulation outside the operating room. Despite a great number of available devices, standardized, structured, and validated training curricula for video simulators are scarce. METHODS: The Lübeck Toolbox (LTB) video trainer provides six training modules and online video tutorials. Proficiency levels for the tasks were defined by performance analysis of MIS experts (n = 15). Mean values of the best performed repetitions were set as benchmarks for a validation study with n = 30 MIS novices and the learning curves calculated. The novices performed a cholecystectomy on a pig organ model before and after the curriculum which were analyzed using the GOALS score. RESULTS: Benchmarks defined by expert performance for the task Nos. 1 to 6 were 72 s (± 8) (Pack Your Luggage), 49 s (± 9) (Weaving), 66 s (± 10) (Chinese Jump Rope), 89 s (± 28) (Triangle Cut), 138 s (± 44) (Hammer Cut), and 98 (± 22) (Suturing). The median numbers of required repetitions by the novices to reach the proficiency level were n = 42 (7-80), n = 26 (9-55), n = 32 (14-77), n = 44 (15-59), n = 19 (6-68), and n = 26 (15-60). These values were all located at the beginning of the plateau phase of the learning curves. GOALS score improved significantly after completion of the curriculum (18.0 (± 2.6) vs. 10.9 (± 1.6), p < 0.0001). CONCLUSION: The LTB curriculum constitutes a new highly standardized and proficiency level-based training program for basic skills in MIS. Transferability of the task content to a (sub)-realistic environment could be demonstrated. Still, future trials will have to further validate the effectiveness of the LTB curriculum.

[Implementation of a Laparoscopic Simulation Training in Undergraduate Medical Education - The Lübeck Toolbox-Curriculum]. / Implementierung eines laparoskopischen Simulationstrainings in der studentischen Lehre ­ das Lübecker Toolbox-Curriculum.

BACKGROUND: Simulation-based training has become increasingly relevant in minimally invasive surgery (MIS). It is unclear whether or not the established Lübeck Toolbox (LTB) Curriculum for the acquisition of basic MIS skills can be implemented to supplement standard undergraduate education in surgery and how it would be accepted. MATERIALS UND METHODS: Since 04/2015, students at the medical school of the University of Lübeck have had the option to complete the highly standardized and validated LTB Curriculum. It consists of six subsequent tasks with pre-defined learning goals. Video tutorials allow for a self-educating approach. The individual training progress is documented continuously as scheduled by the curriculum. The program was evaluated in a standardized manner using an established online platform for the evaluation of university courses at the University of Lübeck. RESULTS: Between 04/2015 and 07/2016, 63 students completed the LTB Curriculum. The general interest in a surgical specialty rose from an average of 1.61 (SD 0.78) before to 1.12 after the curriculum. The numbers of required repetitions for the training tasks 1 - 6 were median 24 (6 - 79), 23 (5 - 61), 7 (5 - 33), 15 (5 - 59), 16 (5 - 50), and 18 (7 - 48), respectively. None of the 63 students terminated the curriculum prematurely. On average, 4.35 (SD 1.58) hours per week were spent training with an overall duration of 4.1 (SD 1.2) weeks required to go through the LTB Curriculum. Evaluation results showed an overall rating of 1.0 (SD 0.17). The average learning progress, didactics and structure of the curriculum were rated as 1.0 (SD 0.24), 1.14 (SD 0.36), and 1.0 (SD 0.24), respectively. The relevance for the following study years and the future professional activity was reported to be 1.2 (SD 0.45) on average. CONCLUSION: As an addition to the regular undergraduate program, the Lübeck Toolbox Curriculum was well accepted by many students. Evaluation showed exceedingly positive results. Furthermore, the data suggest that the LTB Curriculum may increase the interest in a surgical specialty among medical students. This aspect seems to be relevant in times where surgeons should make every effort to recruit young doctors for surgical residency.

Cold-Plasma Coagulation on the Surface of the Small Bowel Is Safe in Pigs.

INTRODUCTION: Surgical treatment in patients with peritoneal carcinomatosis is often limited by the extent of small bowel involvement. We investigated the results of the application of cold-plasma coagulation on the surface of the small bowel. METHODS: After permission by the federal government of Schleswig-Holstein, 8 female pigs underwent a laparoscopy and cold-plasma coagulation on the small bowel with different energy levels. Cold plasma is generated by high-frequency energy that is directed through helium gas. After 12 to 18 days a laparotomy was done and the abdomen was inspected for peritonitis, fistula, or other pathology. RESULTS: Perioperative morbidity was low with transient diarrhea in 1 pig and loss of appetite for 1 day in another pig. We saw 1 interenteric fistula that was clinically not apparent after accidently prolonged application of cold-plasma coagulation (6 seconds instead of 2 seconds) with the highest energy level of 100 W. We did not observe any mortality. The depth of necrosis after application of different energy levels was dependent on the generator energy. We observed statistically significant differences between the different energy levels (20 W vs 10 W [P = .014], 75 W vs 50 W [P = .011]). The comparison of the necrosis depths after the application of 100 W and 75 W almost reached statistical significance (P = .059). We observed distinct interenteric adhesions as a result of the coagulation. DISCUSSION: The application of cold-plasma coagulation on the surface of vital bowel in pigs is safe. We would recommend against the use of the highest energy level of 100 W before more clinical data are available.

Stage-specific frequency and prognostic significance of aneuploidy in patients with sporadic colorectal cancer--a meta-analysis and current overview.

PURPOSE: Aneuploidy has long been suggested as an independent prognostic marker for colorectal cancer (CRC) patients and could thus aid for individualized medicine. However, due to a large spectrum of deviating studies, expert panels do not recommend ploidy assessment. In order to clarify a potential bias of stage-specific frequency of aneuploidy, we now conducted a meta-analysis combined with a systematic review regarding aneuploidy and prognosis. METHODS: A systematic, web-based search process retrieved 1935 studies published in English between 1990 and 2011. The defined endpoint for the meta-analysis was an increase in aneuploidy frequency between early- (Dukes A, B and UICC I, II; n = 3632 samples) and late-stage (Dukes C, D and UICC III, IV; n = 3440 samples) colorectal carcinomas. RESULTS: Of 1935 studies initially identified, 17 image (2130 patients) and 20 (7023 patients) flow cytometric studies were analyzed in detail. The meta-analysis (7072 patients) revealed late-stage CRC to be more frequently aneuploid than early-stage CRC (odds ratio 1.51, 95 % CI 1.37-1.67; p = 0.0007). Independent of tumor stage, the overall range of aneuploidy was 39 to 81 % (median 58 %), and altogether, 21 (54.1 %) studies described a significant prognostic impact of aneuploidy for overall, disease-specific, and recurrence-free survival, respectively. CONCLUSIONS: A substantial number of studies showed a prognostic importance of aneuploidy in CRC. Furthermore, the higher frequency of aneuploidy in late-stage CRC implies an increase in genomic instability with CRC progression, indicating aneuploidy to be also a stage-specific prognostic marker.

Colorectal neoplasia in IBD--a single-center analysis of patients undergoing proctocolectomy.

PURPOSE: The risk, prevention, and treatment of colorectal neoplasia in inflammatory bowel disease (IBD) are still a matter of debate. The aim of this study was to analyze the occurrence of colorectal neoplasia in IBD patients who underwent proctocolectomy. METHODS: The study population comprised of 123 IBD patients who underwent proctocolectomy because of neoplasia, therapy refractivity, or complications between January 2000 and July 2011. RESULTS: One hundred fourteen (92.7%) patients were pre-operatively diagnosed with ulcerative colitis, 5 (4.1%) with colitis indeterminata, and 4 (3.3%) with colonic Crohn's disease. Colectomy was indicated in 39 (31.7%) patients because of a neoplasia, in 68 (55.3%) because of a refractory course of the disease, and in 16 (13.0%) because of complications. Neoplasia was found in 36 patients on a histopathologic evaluation of the colectomy specimens. Ten (8.1%) patients post-operatively showed a pre-operatively not described advanced neoplasia. In three (2.4%) of these patients, the detection of advanced neoplasia (two high-grade intraepithelial neoplasias (IENs), one carcinoma) was a complete de novo finding. Carcinoma had not been diagnosed pre-operatively in six (4.9%) patients. A multifocal distribution of neoplasia was seen in 66.7% of patients with neoplasia. The median duration of disease was 15.5 years in case of neoplasia opposed to 6.0 years in those without neoplasia detection. CONCLUSION: Our data demonstrate a high rate of pre-operatively undetected high-grade IENs and carcinoma and a frequent multifocal occurrence in IBD patients with long-standing inflammation of the colon. This should be kept in mind for treatment decisions particularly in patients with a chronic refractory course of the disease.

Conversion of laparoscopic surgery for perforated peptic ulcer: a single-center study.

PURPOSE: A perforated peptic ulcer can be managed laparoscopically in selected patients. The purpose of this study was to evaluate whether conversion of emergency laparoscopy is inferior to primary median laparotomy in terms of postoperative morbidity and mortality. METHODS: We analyzed patients who underwent laparoscopic or open surgery for a perforated peptic ulcer at the Department of Surgery, University of Schleswig-Holstein, Campus Luebeck between January, 1996 and December, 2010. Perforations were graded according to the Boey classification, a preoperative risk-scoring system. RESULTS: Conversion to laparotomy was necessary in 20 of the 45 patients who underwent laparoscopic surgery (CG); therefore, laparoscopic operations were completed in 25 patients (LG). The third patient cohort comprised 139 patients who underwent primary laparotomy (OG). Overall minor morbidity was significantly lower (p = 0.048) in the LG patients than in the OG patients, whereas no significant differences were found in major morbidity and mortality, particularly between the OG and CG. CONCLUSION: Patients' suitability for laparoscopic management should be decided on according to Boey's clinical scoring system. Our findings demonstrated that conversion from laparoscopy to laparotomy was not associated with elevated postoperative morbidity or mortality versus initial laparotomy. Therefore, emergency operations may be commenced laparoscopically in selected patients, especially considering the postoperative advantages of this approach.

Laparoscopic versus open reversal of a Hartmann procedure: a single-center study.

PURPOSE: Re-anastomosis after a Hartmann procedure is associated with a higher morbidity and mortality than other elective colorectal operations. The goal of this comparative study was to evaluate whether laparoscopic reversal is a justified operative approach, although the initial operation is most often an emergency laparotomy. METHODS: A retrospective analysis was conducted on data collected on all 70 patients who underwent laparoscopic and open reversal of a Hartmann procedure at the Department of Surgery, University of Schleswig-Holstein, Campus Lübeck, between January 1999 and December 2011. Together with general demographic data, the analysis included the indication for the initial Hartmann procedure, time to reversal, intraoperative findings, the choice of operative method, operating time, postoperative pain control, return of normal bowel function, length of hospital stay, and peri- and postoperative morbidity and mortality. RESULTS: In most patients, the Hartmann procedure was performed after a perforated sigmoid diverticulitis. We were not able to find any statistically significant differences with respect to gender, body mass index (BMI) and American Society of Anesthesiologists classification between the laparoscopic group (LG) (N = 24 patients) and the open group (OG) (N = 46). In the LG, patients were significantly younger (p = 0.019). The median operating time was 210 min (75-245) in the LG, which was significantly longer than in the OG (166 min; 66-230). The statistical analysis of the duration of postoperative analgesic therapy (LG 7 days; OG 12 days), return to normal diet (LG 3 days; OG 4 days), return of normal bowel function (LG 3 days; OG 4 days) and length of hospital stay (LOS) (LG 10 days; OG 15 days) detected significant differences in advantage for the LG. Unplanned return to theatre during index admission was only necessary in the OG (N = 7, 15.2 %). With a median follow-up of 8 months (range 1-20), we observed a comparable number of minor complications in both groups but a significantly higher number of major complications in the OG (N = 27, 58.7%) (p = 0.001). Conversion occurred in three cases (12.5%). There was no mortality in either of the two groups. CONCLUSIONS: This study was able to demonstrate the feasibility of the laparoscopic approach. In terms of postoperative results it should be seen as equivalent to the open procedure. However, the laparoscopic approach requires profound surgical expertise. The indication should be made after a careful risk/benefit analysis for each individual patient.