Changing paradigm of sacral neuromodulation and external anal sphincter repair for faecal incontinence in specialist centres.

AIM: The aim of this study was to determine whether the paradigm of surgical intervention for faecal incontinence (FI) has changed between 2000 and 2013. METHOD: This was a multi-centre retrospective study of patients who had undergone either sacral neuromodulation (SNM) or delayed sphincter repair or sphincteroplasty (SR) as a primary surgical intervention for FI in five centres in Europe and one in the United States. The flow of patients according to the intervention, sustainability of the treatment at a minimum follow-up of 5 years, complications and requirement for further interventions were recorded. RESULTS: A total of 461 patients (median age 56 years, range 24-90 years, 41 men) had either SNM or SR as an index operation during the study period [SNM 284 (61.6%), SR 177 (38.4%)]. Among SNM patients, there were 169 revisional operations (change of battery and/or lead, re-siting or removal). At the time of last follow-up 203 patients (71.4%) continued to use SNM. Among SR patients, 30 (16.9%) had complications, most notably wound infection (22, 12.4%). During follow-up 32 patients (18.1%) crossed over to SNM. Comparing two 4-year periods (2000-2003 and 2007-2010), the proportion of patients operated on who had a circumferential sphincter defect of less than 90° was 48 (68%) and 45 (46%), respectively (P = 0.03), while those who had SNM as the primary intervention increased from 29% to 89% (P < 0.05). CONCLUSION: The paradigm of surgical intervention for FI has changed with increasing use of SNM.

European Society of Coloproctology Colorectal Robotic Surgery Training for the Trainers Course - the first pilot experience.

AIM: Currently, there is no established colorectal specific robotic surgery Train the Trainer (TTT) course. The aim was to develop and evaluate such a course which can then be further developed to be incorporated within the planned European Society of Coloproctology (ESCP)/European School of Coloproctology (ESC) robotic colorectal surgery training curriculum. METHOD: After identifying the need for such a course within a training programme, the course was developed by a subgroup of the ESCP/ESC. A scoping literature review was performed and the content and materials for the course were developed by a team consisting of two gastroenterologists with a combined experience of 30 years of facilitating TTT courses, a robotic surgeon and proctor with laparoscopic TTT faculty experience and experienced robotic and laparoscopic colorectal trainers. The course was evaluated by asking delegates to complete pre- and post-course questionnaires. RESULTS: There were eight delegates on the course from across Europe. Delegates increased their knowledge of each of the course learning objectives and identified learning points in order to change practice. The feedback from the delegates of the course was positive across several areas and all felt that they had achieved their own personal objectives in attending the course. CONCLUSION: This pilot robotic colorectal TTT course has achieved its aim and demonstrated many positives. There is a need for such a course and the evaluation processes have provided opportunities for reflection, which will allow the development/tailoring of future robotic colorectal TTT courses to help develop robotic training further.

European expert consensus on a structured approach to training robotic-assisted low anterior resection using performance metrics.

AIM: The aim was to develop and operationally define 'performance metrics' that characterize a reference approach to robotic-assisted low anterior resection (RA-LAR) and to obtain face and content validity through a consensus meeting. METHOD: Three senior colorectal surgeons with robotic experience and a senior behavioural scientist formed the Metrics Group. We used published guidelines, training materials, manufacturers' instructions and unedited videos of RA-LAR to deconstruct the operation into defined, measurable components - performance metrics (i.e. procedure phases, steps, errors and critical errors). The performance metrics were then subjected to detailed critique by 18 expert colorectal surgeons in a modified Delphi process. RESULTS: Performance metrics for RA-LAR had 15 procedure phases, 128 steps, 89 errors and 117 critical errors in women, 88 errors and 118 critical errors in men. After the modified Delphi process the final performance metrics consisted of 14 procedure phases, 129 steps, 88 errors and 115 critical errors in women, 87 errors and 116 critical errors in men. After discussion by the Delphi panel, all procedure phases received unanimous consensus apart from phase I (patient positioning and preparation, 83%) and phase IV (docking, 94%). CONCLUSION: A robotic rectal operation can be broken down into procedure phases, steps, with errors and critical errors, known as performance metrics. The face and content of these metrics have been validated by a large group of expert robotic colorectal surgeons from Europe. We consider the metrics essential for the development of a structured training curriculum and standardized procedural assessment for RA-LAR.

Training in colorectal surgery in Europe and 20 years of the European Board of Surgical Qualification coloproctology examination.

AIM: Training in colorectal surgery across Europe is not yet standardized. The European Board of Surgical Qualification (EBSQ) coloproctology examination has been held annually since 1998. The aims of this study were to illustrate the current situation of coloproctology specialization in Europe and to analyse the EBSQ examinations held over the last 20 years. METHOD: A survey, focused on current training and education in colorectal surgery in Europe, was conducted among all national representatives of the European Society of Coloproctology (ESCP) in 2018. Candidate demographics (1998-2018) and the results of the EBSQ examination (2007-2018) were analysed. RESULTS: In Europe, there are currently 26 national colorectal societies, 27 national annual colorectal meetings, 16 national specialized training programmes and 13 national colorectal fellowships. Six countries have board certification in colorectal surgery and five a dedicated examination. During the last 20 years, 475 candidates from 29 countries, of whom 88 (19%) were women, passed the EBSQ examination. The pass rate was higher in younger applicants (< 42 years, P = 0.01). The success rate was higher for candidates with academic experience (more than five publications or presentations) and with an academic title (thesis) (P = 0.01). CONCLUSION: Colorectal surgical training is still not standardized in Europe, although efforts have been made to recognize colorectal surgery as an independent speciality. The number of holders of the EBSQ Diploma has increased over the years, demonstrating the acceptance of the examination among European surgeons. Young candidates with an academic profile are the most successful.

Permacol™ collagen paste for cryptoglandular and Crohn's anal fistula.

BACKGROUND: Permacol™ collagen paste, an acellular crosslinked porcine dermal collagen matrix suspension, is a new treatment option for anal fistula. Data remain limited, however, and as yet only the results of one case of Crohn's fistula treated with Permacol™ paste has been reported. The aim of this study was to assess the use of Permacol™ collagen paste in patients with cryptoglandular and Crohn's perianal fistulae. METHODS: A prospective study was conducted on patients with anal fistula, treated with Permacol™ paste. Patients were followed at 1 week, 6 and 12 months, and on demand thereafter. The main focus was on fistula healing and postoperative continence. The former was defined as the absence of signs of recurrence on clinical examination, proctoscopy and rigid rectoscopy. Fecal incontinence was assessed before surgery and at each follow-up. RESULTS: Thirty patients (19 women, 11 men; mean age 46 years), 12 (40%) of whom had Crohn's disease were included. The average number of previous fistula operations was 6. All patients had ≥ 6 months of follow-up, and 24 patients (80%) had ≥ 12 months of follow-up. The healing rate in all patients was 57% (17 of 30 patients) at 6 months and 63% (15 of 24 patients) at 12 months. One patient reported a worsening of fecal incontinence at 12 months; 2 patients had adverse events (perianal pain: n = 1, fluid accumulation n = 1) requiring fistula drainage. Patient characteristics, healing, incontinence, and adverse events did not differ significantly between patients with and without Crohn's disease. CONCLUSIONS: Our data indicate that Permacol™ paste is a safe and moderately effective treatment for cryptoglandular and Crohn's fistulae.

Ventral rectopexy with biological mesh: short-term functional results.

PURPOSE: Ventral mesh rectopexy (VMR) is an established, minimally invasive, nerve-sparing procedure for the treatment of various symptomatic morphological changes in the posterior pelvic compartment. We present the short-term functional outcome and patient satisfaction after laparoscopic and robotic VMR with biological mesh. METHODS: We analyzed data from 123 patients who underwent laparoscopic ventral mesh rectopexy (LVMR) or robotic ventral mesh rectopexy (RVMR) from August 2012 to January 2017. Included in these data were patient demographics, intra- and postoperative findings, Cleveland Clinic Constipation Score (CCCS), Obstructed Defecation Score Longo (ODS), Cleveland Clinic Incontinence Score (CCIS), and patient satisfaction as measured by visual analog scale (0-10). RESULTS: Improvements in CCCS, CCIS, and ODS were statistically significant at 6 and 12 months (p < 0.001). Patient satisfaction was excellent at 6 and 12 months (8.2/10 and 8.3/10, respectively). The overall complication rate was 14%, with a major complication rate of 2%. No mesh-related complications were observed. The need for surgical re-intervention because of relapse, symptom persistence or recurrence, or new symptoms was 3%. Outcome appears to be similar between LVMR and RVMR. CONCLUSIONS: Both LVMR and RVMR with biological mesh are safe and effective in reducing symptoms, as measured by CCCS, CCIS, and ODS, and patient satisfaction is high.

Effectiveness of sacral nerve stimulation in fecal incontinence after multimodal oncologic treatment for pelvic malignancies: a multicenter study with 2-year follow-up.

BACKGROUND: To assess whether sacral nerve stimulation (SNS) is an effective treatment for severe fecal incontinence (FI) after radiotherapy (RT)/chemoRT (CRT) in combination with pelvic surgery. METHODS: A multicenter study was conducted on patients with FI that developed after multimodal therapy for pelvic tumors and was refractory to non-operative management, who were treated with SNS between November 2009 and November 2012. Data were prospectively collected and retrospectively analyzed. Cleveland Clinic FI score (CCFIS), FI episodes per week, FI Quality of Life (FIQoL), anorectal manometry and pudendal nerve terminal motor latency were evaluated before and after SNS. RESULTS: Eleven patients (seven females, mean age 67.3 ± 4.8 years) were evaluated in the study period. Multimodal treatments included surgery and CRT (four rectal, two cervical and one prostate cancers), surgery and RT (one cervical and two endometrial cancers) and CRT (one anal cancer). The mean radiation dose was 5.3 Gy, and mean interval between the end of RT and onset of FI was 43.7 ± 23 months. Before SNS, the mean CCFIS and the mean number of FI episodes per week were 15.7 ± 2.8 and 12.3 ± 4.2, respectively. At 12-month follow-up, mean CCFIS improved to 3.6 ± 1.8 (p = 0.003) and the mean number of FI episodes decreased to 2.0 ± 1.9 per week (p = 0.003). These results persisted at 24-month follow-up. Significant improvement was also observed for each of the four domains of FIQoL at 12- and 24-month follow-up. Anorectal manometry values did not change significantly at follow-up. CONCLUSIONS: SNS is feasible and may be an effective therapeutic option for FI after multimodal treatment of pelvic malignancies.

Social media use in German visceral surgeons: a cross-sectional study of a national cohort.

AIM: Engagement in social media is increasing. Medical professionals have been adapting LinkedIn, a professional networking site, and Twitter, a microblogging service, for a number of uses. This development has been described for a number of medical specialties, but there remains a paucity of European data. A study was undertaken to measure the engagement and activity of German visceral surgeons on social media platforms. METHOD: Visceral surgeons were identified from 15 regional Associations of Statutory Health Insurance Physicians (Kassenärztliche Vereinigungen) opt-in registers. A manual search was subsequently performed across key professional social media platforms. The presence of a profile and key markers of use were recorded. RESULTS: In total, 575 visceral surgeons were identified. 523 (93%) were men. 183 (31%) surgeons engaged in professional social media. 22 (3.8%) used Twitter, producing a mean of 16.43 tweets with a mean of 7.57 followers. 137 (24%) surgeons had a profile on LinkedIn with a mean of 46.36 connections. Female surgeons were less connected on LinkedIn (P < 0.005). 60 (10%) used Xing, with a mean of 27.95 connections. There were no significant differences in use of social media between surgeons from Eastern and Western Germany (P = 0.262) or male and female surgeons (P = 0.399). CONCLUSIONS: German visceral surgeons are less engaged and less active on social media than previously examined cohorts. Loco-regional, cultural, demographic and regulatory matters may have a significant influence on uptake. If this surgical cohort wishes to have a wider international presence then education on the potential benefits of these tools may be needed.

Short-term outcomes of laparoscopic ventral rectopexy for obstructed defecation in patients with overt pelvic structural abnormalities-a Chinese pilot study.

AIM: As laparoscopic ventral rectopexy (LVR) gained increasing popularity in the past decade, studies from non-western area remain rare. The aim of this pilot study is to evaluate the efficacy and safety of LVR for obstructed defecation (OD) in Chinese patients with overt pelvic structural abnormalities. METHODS: A series of 19 consecutive patients is presented undergoing LVR for OD. All patients showed various forms of pelvic structural abnormalities which were verified by dynamic defecography exam. Data was prospectively recorded and the functional outcomes were evaluated using the Cleveland Clinic Constipation Score (CCCS) and Patients Assessment of Constipation Quality of Life Score (PAC-QoL). RESULTS: Pelvic structural abnormalities of the 19 patients included external rectal prolapse (ER) in 10.5% (2/19), high grade internal rectal prolapse (IR) in 57.8% (11/19), rectocele in 52.6% (10/19), enterocele in 15.7% (3/19), cystocele/vaginal prolapse in 15.7 (3/19), descending perineum (DP) in 63.5% (12/19). 89.4% patients (17/19) showed at least two co-existed abnormalities and 15.7% (3/19) showed multicompartmental abnormalities. The mean follow-up was 9 months (range 1-18). No mesh-related complication was observed. At last available follow-up (LAFU), improvement of OD symptom was observed in 15 (78.9%) patients, the mean scores of CCCS decreased from 17 to 10 (p < 0.05), all four subsets of PAC-QoL scores improved, and three of them (physical discomfort, worries and concerns, satisfaction) showed statistical significance (p < 0.05). CONCLUSION: Laparoscopic ventral rectopexy appears to be a safe and effective procedure for obstructed defecation in Chinese patients with overt pelvic structural abnormalities in short-term follow-up.

Sacral nerve stimulation for faecal incontinence in patients with sacral malformation.

INTRODUCTION: Sacral nerve stimulation (SNS) is a common and effective treatment for faecal incontinence (FI), but accessibility of the sacral nerves is mandatory. In some cases, electrode placement fails for unknown reasons. A frequent cause could be sacral malformations, which have a high incidence (up to 24.1%) and can be unsuspected. METHODS AND RESULTS: We report two patients with FI consequent to congenital anorectal malformation and associated sacral malformation. Despite partial sacral agenesis, SNS was feasible in both. They benefitted greatly from SNS, with an improved ability to postpone the urge up to at least 15 min, reduced incontinence episodes (at least 50%), and significantly better quality of life. CONCLUSION: SNS may be feasible in patients with FI, even in the presence of sacral malformation. However, clinicians should be aware of the attendant technical difficulties. Preoperative imaging, preferably with MRI of the sacrum, is advisable. If the sacral spinal nerves are inaccessible technically, pudendal nerve stimulation could be considered, if anatomy permits.

Surface anatomical landmarks for the location of posterior sacral foramina in sacral nerve stimulation.

BACKGROUND: Sacral nerve stimulation is a common treatment for various pelvic floor disorders. It consists of the percutaneous introduction of electrodes through the posterior sacral foramina for therapeutic stimulation of the target sacral spinal nerve. The aim of our study was to determine the surface anatomical landmarks of the sacrum to facilitate identification of the posterior sacral foramina. METHODS: This study was conducted on 20 human cadavers. The cadavers were placed in a prone position, and all the soft tissues of the sacral region were removed to allow exposure of the osseous structures. Different measurements were taken in relation to the posterior sacral foramina, the posterior superior iliac spine (PSIS) and the median sacral crest (MSC). A median coefficient of variation (CV) was determined. RESULTS: The diameter of the second sacral foramen showed the greatest variability. The distances between each individual foramen and the MSC had an acceptable variability (CV < 20%). In contrast, the distance between foramina had a high variability. The distance between PSIS and the second posterior sacral foramen was also found to have an acceptable variability (CV < 20%). However, the angle formed by an horizontal line between PSIS and a line between PSIS and S2 foramina had high variability. CONCLUSIONS: We found that the distance between sacral foramina and MSC is relatively constant while the distance between foramina and the relations between foramina and PSIS is highly variable. Detailed knowledge of the anatomy may facilitate electrode placement and is complementary to the regular use of fluoroscopy.

Prognosis of patients with colonic carcinoma before, during and after implementation of complete mesocolic excision.

BACKGROUND: The implementation of complete mesocolic excision (CME) for colonic cancer was accompanied by other important changes, including more patients with early diagnosis by screening and the introduction of adjuvant chemotherapy in patients with stage III disease. The contribution of CME remains unclear. METHODS: In this observational study, data from patients with stage I-III colonic carcinoma were analysed by comparing five time intervals: 1978-1984 (pre-CME), 1985-1994 (CME development), 1995-2002 (CME implementation), 2003-2009 (CME) and 2010-2014 (CME), with a special focus on indicators of process and outcome quality. RESULTS: During the observed periods, the median age of patients increased (from 65 to 67 years), there were more right-sided carcinomas (from 17·0 to 32·4 per cent), more stage I disease (from 14·0 to 27·7 per cent) and fewer patients with regional lymph node metastases (from 42·7 to 32·0 per cent). The proportion of patients with pN0 disease and at least 12 examined regional lymph nodes increased (from 84·8 to 100 per cent) as did the R0 resection rate (from 97·0 to 100 per cent). Overall morbidity increased, whereas the in-hospital mortality rate was stable (range 1·8-3·7 per cent). Use of adjuvant chemotherapy in stage III colonic carcinoma increased from 0 to 79 per cent. The improvement in outcome quality was more evident in stage III than in stage I-II tumours. In stage III, the 5-year locoregional recurrence rate decreased from 14·8 to 4·1 per cent (P = 0·046) and the 5-year cancer-related survival rate increased from 61·7 to 80·9 per cent (P = 0·010). CONCLUSION: With CME, the quality indicators of process and outcome quality improved, especially in stage III colonic carcinoma. Adjuvant chemotherapy in stage III and multidisciplinary approaches in patients with metachronous distant metastases contributed to further outcome improvement.

Sacral malformations: use of imaging to optimise sacral nerve stimulation.

INTRODUCTION: The success of sacral nerve stimulation, a common treatment for pelvic floor disorders, depends on correct placement of the electrodes through the sacral foramina. When the bony anatomy and topography of the sacrum and sacral spinal nerves are intact, this is easily achieved; where sacral anomalies exist, it can be challenging. A better understanding of common sacral malformations can improve the success of sacral nerve stimulation (SNS) electrode placement. MATERIAL AND METHODS: We reviewed 998 consecutive MRI scans performed to investigate low back pain in patients who had undergone CT and/or X-ray. RESULTS: Congenital sacral malformations were found in 24.1%, the most common being sacral meningeal cysts (16%) and spina bifida occulta (9.9%). Others were lumbosacral transitional vertebrae (2.5%), anterior occult meningocele (0.5%), partial sacral agenesis (0.2%) and vertebral dysplasia of S1 (0.2%). CONCLUSION: This radiologic review uncovered a high incidence of sacral malformations, and most were asymptomatic. All surgeons who perform SNS should have a basic understanding of sacral malformations, their incidence and effect on foraminal anatomy. Imaging will aid procedural planning.

Sacral neuromodulation for persistent faecal incontinence after laparoscopic ventral rectopexy for high-grade internal rectal prolapse.

AIM: Internal rectal prolapse is recognized as an aetiological factor in faecal incontinence. Patients found to have a high-grade internal rectal prolapse on routine proctography are offered a laparoscopic ventral rectopexy after failed maximum medical therapy. Despite adequate anatomical repair, faecal incontinence persists in a number of patients. The aim of this study was to evaluate the outcome of sacral neuromodulation in this group of patients. METHOD: Between August 2009 and January 2012, 52 patients who underwent a laparoscopic ventral rectopexy for faecal incontinence associated with high-grade internal rectal prolapse had persistent symptoms of faecal incontinence and were offered sacral neuromodulation. Symptoms were evaluated before and after the procedure using the Fecal Incontinence Severity Index (FISI) and the Gastrointestinal Quality of Life Index (GIQLI). RESULTS: Temporary test stimulation was successful in 47 (94%) of the patients who then underwent implantation of a permanent pulse generator. The median FISI score 1 year after sacral neuromodulation was lower than the median score before [34 (28-59) vs. 19 (0-49); P < 0.01], indicating a significant improvement in faecal continence. Quality of life (GIQLI) was significantly better after starting sacral neuromodulation [78 (31-107) vs. 96 (55-129); P < 0.01]. CONCLUSION: Patients may benefit from sacral neuromodulation for persisting faecal incontinence after laparoscopic ventral rectopexy.

Long-term outcomes of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) has proven short- to medium-term effectiveness for the treatment of faecal incontinence (FI); fewer long-term outcomes have been presented and usually in small series. Here, the long-term effectiveness of SNS was evaluated in a large European cohort of patients with a minimum of 5 years' follow-up. METHODS: Prospectively registered data from patients with FI who had received SNS for at least 5 years from ten European centres were collated by survey. Daily stool diaries, and Cleveland Clinic and St Mark's incontinence scores were evaluated at baseline, after implantation and at the last follow-up. SNS was considered successful when at least 50 per cent symptom improvement was maintained at last follow-up. RESULTS: A total of 407 patients underwent temporary stimulation, of whom 272 (66·8 per cent) had an impulse generator implanted; 228 (56·0 per cent) were available for long-term follow-up at a median of 84 (i.q.r. 70-113) months. Significant reductions in the number of FI episodes per week (from median 7 to 0·25) and summative symptom scores (median Cleveland Clinic score from 16 to 7, St Mark's score from 19 to 6) were recorded after implantation (all P < 0·001) and maintained in long-term follow-up. In per-protocol analysis, long-term success was maintained in 71·3 per cent of patients and full continence was achieved in 50·0 per cent; respective values based on intention-to-treat analysis were 47·7 and 33·4 per cent. Predictive analyses determined no significant association between pretreatment variables and successful outcomes. Risk of long-term failure correlated with minor symptom score improvement during the temporary test phase. CONCLUSION: SNS remains an effective treatment for FI in the long term for approximately half of the patients starting therapy.

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement.

AIM: In Europe during the last decade sacral nerve stimulation (SNS) or sacral neuromodulation (SNM) has been used to treat faecal incontinence (FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/SNM for FI and constipation. METHOD: A systematic literature search of SNS for FI and constipation was conducted using PubMed. A set of questions derived from the search and expert opinion were answered on-line on two occasions by an international panel of specialists from Europe. A 1-day face-to-face meeting of the experts finalized the discussion. RESULTS: Three hundred and ninety-three articles were identified from the literature search, of which 147 fulfilled the inclusion criteria. Twenty-two specialists in FI and constipation from Europe participated. Agreement was achieved on 43 (86%) of 50 domains including the set-up of service, patient selection, baseline investigations, operative technique and programming of the device. The median of agreement was 95% (35-100%). CONCLUSION: Consensus was achieved on the majority of domains of SNS/SNM for FI and constipation. This should serve as a benchmark for safe and quality practice of SNS/SNM in Europe.

Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence.

BACKGROUND: Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms. METHODS: In a prospective multicenter trial, 136 patients with FI received the NASHA Dx bulking agent. Treatment success defined as a reduction in number of FI episodes by 50% or more compared with baseline (Responder50 ). Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life Scale (FIQL), and adverse events were also evaluated. KEY RESULTS: Successful decrease in symptoms was achieved in 52% of patients at 6 months and this was sustained at 12 months (57%) and 36 months (52%). Mean CCFIS decreased from 14 at baseline to 11 at 36 months (p < 0.001). Quality-of-life scores for all four domains improved significantly between baseline and 36 months of follow-up. Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort. CONCLUSIONS & INFERENCES: Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3 years.