Analysis of factors that indicated surgery in 400 patients submitted to a complete diagnostic workup for obstructed defecation syndrome and rectal prolapse using a supervised machine learning algorithm.

BACKGROUND: Patient selection is extremely important in obstructed defecation syndrome (ODS) and rectal prolapse (RP) surgery. This study assessed factors that guided the indications for ODS and RP surgery and their specific role in our decision-making process using a machine learning approach. METHODS: This is a retrospective analysis of a long-term prospective observational study on female patients reporting symptoms of ODS who underwent a complete diagnostic workup from January 2010 to December 2021 at an academic tertiary referral center. Clinical, defecographic, and other functional tests data were assessed. A supervised machine learning algorithm using a classification tree model was performed and tested. RESULTS: A total of 400 patients were included. The factors associated with a significantly higher probability of undergoing surgery were follows: as symptoms, perineal splinting, anal or vaginal self-digitations, sensation of external RP, episodes of fecal incontinence and soiling; as physical examination features, evidence of internal and external RP, rectocele, enterocele, or anterior/middle pelvic organs prolapse; as defecographic findings, intra-anal and external RP, rectocele, incomplete rectocele emptying, enterocele, cystocele, and colpo-hysterocele. Surgery was less indicated in patients with dyssynergia, severe anxiety and depression. All these factors were included in a supervised machine learning algorithm. The model showed high accuracy on the test dataset (79%, p < 0.001). CONCLUSIONS: Symptoms assessment and physical examination proved to be fundamental, but other functional tests should also be considered. By adopting a machine learning model in further ODS and RP centers, indications for surgery could be more easily and reliably identified and shared.

Technical modifications for cost optimization in robot-assisted ventral mesh rectopexy: an initial experience.

BACKGROUND: Robot-assisted ventral mesh rectopexy is considered a valid option in the treatment of rectal prolapse. However, it involves higher costs than the laparoscopic approach. The aim of this study is to determine if less expensive robotic surgery for rectal prolapse can be safely performed. METHODS: This study was conducted on consecutive patients who underwent robot-assisted ventral mesh rectopexy at Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, from 7 November 2020 to 22 November 2021. The cost of hospitalization, surgical procedure, robotic materials, and operating room resources in patients undergoing robot-assisted ventral mesh rectopexy with the da Vinci Xi Surgical Systems was analyzed before and after technical modifications, including the reduction of robotic arms and instruments, and the execution of a double minimal peritoneal incision at the pouch of Douglas and sacral promontory (instead of the traditional inverted J incision). RESULTS: Twenty-two robot-assisted ventral mesh rectopexies were performed [21 females, 95.5%, median age 62.0 (54.8-70.0) years]. After an initial experience performing traditional robot-assisted ventral mesh rectopexy in four patients, we adopted technical modifications in other cases. No major complication or conversion to open surgery occurred. In total, mean cost of hospitalization, surgical procedure, robotic materials, and operating room resources was €6995.5 ± 1058.0, €5912.7 ± 877.0, €2797.6 ± 545.6, and €2608.3 ± 351.5, respectively. Technical modifications allowed a significant reduction in the overall cost of hospitalization (€6604.5 ± 589.5 versus €8755.0 ± 906.4, p = 0.001), number of robotic instruments (3.1 ± 0.2 versus 4.0 ± 0.8 units, p = 0.026), and operating room time (201 ± 26 versus 253 ± 16 min, p = 0.003). CONCLUSIONS: Considering our preliminary results, robot-assisted ventral mesh rectopexy with appropriate technical modifications can be cost-effective and safe.

Haemorrhoidal haemodynamic changes in patients with haemorrhoids treated using Doppler-guided dearterialization.

BACKGROUND: Arterial hyperflow to haemorrhoids has been implicated as a possible pathophysiological co-factor in haemorrhoidal disease. The purpose of this study was to investigate how transanal haemorrhoidal dearterialization (THD) can influence haemodynamic parameters at the level of the haemorrhoidal piles. METHODS: Patients with grade III haemorrhoids selected for THD between July and December 2018 were evaluated using endoanal ultrasonography and colour Doppler imaging at the level of internal haemorrhoids before and 1 year after the surgical procedure. Peak systolic velocity, pulsatility index, resistivity index, acceleration time, and end-diastolic velocity were measured, and preoperative and postoperative values compared. Symptom severity was measured using a symptom-based questionnaire (score range 0-20). RESULTS: Of 21 patients treated, 17 completed the study. Compared with preoperative values, postoperative peak systolic velocity (mean(s.d.) 18.7(1.1) versus 10.3(0.4) cm/s; P < 0.05), pulsatility index (5.5(0.3) versus 2.8(0.4); P < 0.050), and resistivity index (1.0(0.2) versus 0.8(0.5); P < 0.050) decreased significantly, whereas acceleration time increased significantly (65.6(3.6) versus 83.3(4.7) cm/s2; P < 0.050); end-diastolic velocity did not change (1.9(0.2) versus 2.0(0.4); P = 0.753). Symptoms disappeared or had improved significantly in all patients by 1 year after surgery. The mean(s.d.) total symptom severity score decreased from 15.8(1.1) to 1.2(1.6) (P < 0.001). CONCLUSION: THD affects the main haemodynamic parameters at the level of internal haemorrhoids and is associated with a decrease in arterial hyperflow.

Simple fistula-in-ano: is it all simple? A systematic review.

BACKGROUND: Simple anal fistula is one of the most common causes of proctological surgery and fistulotomy is considered the gold standard. This procedure, however, may cause complications. The aim of this systematic review was to assess the surgical treatment of simple anal fistula with traditional and sphincter-sparing techniques. METHODS: A literature research was performed using PubMed, Cochrane, and Google Scholar to identify studies on the surgical treatment of simple anal fistulas. Observational studies and randomized clinical trials were included. We assessed the risk of bias of included studies using the Jadad scale for randomized controlled trials, and the MINORS Scale for the remaining studies. RESULTS: The search returned 456 records, and 66 studies were found to be eligible. The quality of the studies was generally low. A total of 4883 patients with a simple anal fistula underwent a sphincter-cutting procedure, mainly fistulotomy, with a weighted average healing rate of 93.7%, while any postoperative continence impairment was reported in 12.7% of patients. Sphincter-sparing techniques were adopted to treat 602 patients affected by simple anal fistula, reaching a weighted average success rate of 77.7%, with no study reporting a significant postoperative incontinence rate. The postoperative onset of fecal incontinence and the recurrence of the disease reduced patients' quality of life and satisfaction. CONCLUSIONS: Surgical treatment of simple anal fistulas with sphincter-cutting procedures provides excellent cure rates, even if postoperative fecal incontinence is not a negligible risk. A sphincter-sparing procedure could be useful in selected patients.

Internet and social media use among patients with colorectal diseases (ISMAEL): a nationwide survey.

AIM: Social media are used daily by both healthcare workers and patients. Online platforms have the potential to provide patients with useful information, increase their engagement and potentially revolutionize the patient-physician relationship. This survey aimed to evaluate the impact of the Internet and social media (I&SM) on patients affected by colorectal and proctological diseases to define a pathway to develop an evidence-based communications strategy. METHOD: A 31-item anonymous electronic questionnaire was designed. It consisted of different sections concerning demographics and education, reason for the visit, knowledge of the diseases, frequency of I&SM use and patients' opinions about physicians' websites. RESULTS: Over a 5-month period, 37 centres and 105 surgeons took part in the survey, and a total of 5800 patients enrolled. Approximately half of them reported using the Internet daily, and 74.6% of the study population used it at least once per week. There was a correlation (P < 0.001) between those who used the Internet for work and those who had knowledge of both symptoms and the likely diagnosis before consultation. Patients who used the Internet daily were more likely to request a consultation within 6 months of symptom onset (P < 0.0001). Patients with anorectal diseases were more likely to know about their disease and symptoms before the visit (P < 0.001). CONCLUSION: Colorectal patients use I&SM to look for health-related information mainly after their medical visit. Surgeons and hospital networks should plan a tailored strategy to increase patient engagement, delivering appropriate information on social media.

Engineering approaches for drug delivery systems production and characterization.

To find and to test the therapeutic effectiveness (and the limited adverse effects) of a new drug is a long and expensive process. It has been estimated a period of ten years and an expense of the order of one billion USD are required. Meanwhile, even if a promising molecule has been identified, there is the need for operative methods for its delivery. The extreme case is given by gene therapy, in which molecules with tremendous in-vitro efficacy cannot be used in practice because of the lack in useful vector systems to deliver them. Most of the recent efforts in pharmaceutical sciences are focused on the development of novel drug delivery systems (DDSs). In this review, the work done recently on the development and testing of novel DDSs, with particular emphasis on the results obtained by European research, is summarized. In the first section of the review the DDSs are analyzed accordingly with their scale-size: starting from nano-scale (liposomes, nanoparticles), up to the micro-scale (microparticles), until the macroscopic world is reached (granules, matrix systems). In the following two sections, non-conventional testing methods (mechanical methods and bio-relevant dissolution methods) are presented; at last, the importance of mathematical modeling to describe drug release and related phenomena is reported.

Efficacy of Sphinkeeper™ implant in treating faecal incontinence.

The primary aim of this prospective study was to assess the efficacy of Sphinkeeper™ (SK) implantation in patients with faecal incontinence. Forty-two patients with faecal incontinence (14 with sphincter defects) underwent SK implantation and were followed up for a mean(s.d.) of 15·9(8·6) months. SK implantation was a safe and effective method that improved patients' quality of life. Implants and incontinence.

Fistulotomy and primary sphincteroplasty for anal fistula: long-term data on continence and patient satisfaction.

BACKGROUND: The aim of this study was to evaluate the safety and long-term efficacy of fistulotomy and primary sphincteroplasty (FIPS). Secondary endpoints were its impact on postoperative continence status and patients' satisfaction. METHODS: A retrospective study was conducted on patients with cryptoglandular anal fistula (AF) who had FIPS between June 2006 and May 2017. Patients were evaluated with standardized telephone interviews and clinical/instrumental assessment. Main outcome measures included fistula healing rate, continence status, and patient satisfaction. Incontinence was defined as an inability to hold either gas, liquid, or solid stools, as well as postdefecation soiling, and was measured by the Cleveland Clinic fecal incontinence score. Patient satisfaction was evaluated by an 11-point numeric rating scale. RESULTS: There were 203 patients (139 males; mean age: 48.7 years) who had FIPS. The overall healing rate was 93% (188 patients) with a mean follow-up period of 56 ± 31 months. Half of the total cohort (51%) had a complex fistula. Preoperatively, 8 (4%) patients complained of postdefecation soiling and 2 (1%) of gas incontinence. Postoperatively, 26 (13%) patients had continence impairment (de novo n = 24), mainly consisting of postdefecation soiling (10%). In univariate analysis, patients with recurrent (RR 6.153 95% CI 2.097-18.048; p = 0.002) or complex (RR 3.005 95% CI 1.203-7.506; p = 0.012) AF and those with secondary tracts (RR 8.190 95% CI 2.188-30.654; p = 0.004) or previous set on drainage (RR 5.286 95% CI 2.235-12.503; p = 0.0001) were at higher risk of incontinence. In multivariate analysis, no significant predictors were found, although fistula complexity approached statistical significance (RR 5.464 95% CI 0.944-31.623; p = 0.050). The mean patient satisfaction numeric rating scale was 9.3 ± 1.6. Lower satisfaction rates were found in patients with transphincteric (p = 0.011) or complex (p = 0.0001) AF, with secondary tracts (p = 0.041) or previous seton drainage (p = 0.008), and in those with postoperative continence impairment (p = 0.0001). Postoperative onset of incontinence was the only significant factor in multivariate analysis (p = 0.0001). CONCLUSIONS: FIPS should be considered a valid therapeutic option for selected AF. However, the risk of postoperative minor fecal incontinence exists, and should be discussed during preoperative patient counselling.

Contemporary surgical practice in the management of anal fistula: results from an international survey.

BACKGROUND: Management of anal fistula (AF) remains challenging with many controversies. The purpose of this study was to explore current surgical practice in the management of AF with a focus on technical variations among surgeons. METHODS: An online survey was conducted by inviting all surgeons and physicians on the membership directory of European Society of Coloproctology and American Society of Colon and Rectal Surgeons. An invitation was extended to others via social media. The survey had 74 questions exploring diagnostic and surgical techniques. RESULTS: In March 2018, 3572 physicians on membership directory were invited to take part in the study 510 of whom (14%) responded to the survey. Of these respondents, 492 (96%) were surgeons. Respondents were mostly colorectal surgeons (84%) at consultant level (84%), age ≥ 40 years (64%), practicing in academic (53%) or teaching (30%) hospitals, from the USA (36%) and Europe (34%). About 80% considered fistulotomy as the gold standard treatment for simple fistulas. Endorectal advancement flap was performed using partial- (42%) or full-thickness (44%) flaps. Up to 38% of surgeons performed ligation of the intersphincteric fistula tract (LIFT) sometimes with technical variations. Geographic and demographic differences were found in both the diagnostic and therapeutic approaches to AF. Declared rates of recurrence and fecal incontinence with these techniques were variable and did not correlate with surgeons' experience. Only 1-4% of surgeons were confident in performing the most novel sphincter-preserving techniques in patients with Crohn's disease. CONCLUSIONS: Profound technical variations exist in surgical management of AF, making it difficult to reproduce and compare treatment outcomes among different centers.

Estrogen receptor ß controls proliferation of enteric glia and differentiation of neurons in the myenteric plexus after damage.

Injury to the enteric nervous system (ENS) can cause several gastrointestinal (GI) disorders including achalasia, irritable bowel syndrome, and gastroparesis. Recently, a subpopulation of enteric glial cells with neuronal stem/progenitor properties (ENSCs) has been identified in the adult ENS. ENSCs have the ability of reconstituting the enteric neuronal pool after damage of the myenteric plexus. Since the estrogen receptor ß (ERß) is expressed in enteric glial cells and neurons, we investigated whether a selective ERß agonist, LY3201, can influence neuronal and glial cell differentiation. Myenteric ganglia from the murine muscularis externa were isolated and cultured in either glial cell medium or neuronal medium. In glial cell medium, the number of glial progenitor cells (Sox10+) was increased by fourfold in the presence of LY3201. In the neuronal medium supplemented with an antimitotic agent to block glial cell proliferation, LY3201 elicited a 2.7-fold increase in the number of neurons (neurofilament+ or HuC/D+). In addition, the effect of LY3201 was evaluated in vivo in two murine models of enteric neuronal damage and loss, namely, high-fat diet and topical application of the cationic detergent benzalkonium chloride (BAC) on the intestinal serosa, respectively. In both models, treatment with LY3201 significantly increased the recovery of neurons after damage. Thus, LY3201 was able to stimulate glial-to-neuron cell differentiation in vitro and promoted neurogenesis in the damaged myenteric plexus in vivo. Overall, our study suggests that selective ERß agonists may represent a therapeutic tool to treat patients suffering from GI disorders, caused by excessive neuronal/glial cell damage.

Th17-type cytokines, IL-6 and TNF-α synergistically activate STAT3 and NF-kB to promote colorectal cancer cell growth.

Colorectal cancers (CRCs) often show a dense infiltrate of cytokine-producing immune/inflammatory cells. The exact contribution of each immune cell subset and cytokine in the activation of the intracellular pathways sustaining CRC cell growth is not understood. Herein, we isolate tumor-infiltrating leukocytes (TILs) and lamina propria mononuclear cells (LPMCs) from the tumor area and the macroscopically unaffected, adjacent, colonic mucosa of patients who underwent resection for sporadic CRC and show that the culture supernatants of TILs, but not of LPMCs, potently enhance the growth of human CRC cell lines through the activation of the oncogenic transcription factors signal transducer and activator of transcription 3 (STAT3) and nuclear factor-kappa B (NF-kB). Characterization of immune cell complexity of TILs and LPMCs reveals no differences in the percentages of T cells, natural killer T cells, natural killer (NK) cells, macrophages and B cells. However, T cells from TILs show a functional switch compared with those from LPMCs to produce large amounts of T helper type 17 (Th17)-related cytokines (that is, interleukin-17A (IL-17A), IL-17F, IL-21 and IL-22), tumor necrosis factor-α (TNF-α) and IL-6. Individual neutralization of IL-17A, IL-17F, IL-21, IL-22, TNF-α or IL-6 does not change TIL-derived supernatant-driven STAT3 and NF-kB activation, as well as their proproliferative effect in CRC cells. In contrast, simultaneous neutralization of both IL-17A and TNF-α, which abrogates NF-kB signaling, and IL-22 and IL-6, which abrogates STAT3 signaling, reduces the mitogenic effect of supernatants in CRC cells. IL-17A, IL-21, IL-22, TNF-α and IL-6 are also produced in excess in the early colonic lesions in a mouse model of sporadic CRC, associated with enhanced STAT3/NF-kB activation. Mice therapeutically given BP-1-102, an orally bioavailable compound targeting STAT3/NF-kB activation and cross-talk, exhibit reduced colon tumorigenesis and diminished expression of STAT3/NF-kB-activating cytokines in the neoplastic areas. These data suggest that strategies aimed at the cotargeting of STAT3/NF-kB activation and interaction between them might represent an attractive and novel approach to combat CRC.

A functional role for Smad7 in sustaining colon cancer cell growth and survival.

Initially identified as an inhibitor of transforming growth factor (TGF)-ß mainly owing to its ability to bind TGF-ß receptor type I and abrogate TGF-ß-driven signaling, Smad7 can interact with additional intracellular proteins and regulate TGF-ß-independent pathways, thus having a key role in the control of neoplastic processes in various organs. Genome-wide association studies have shown that common alleles of Smad7 influence the risk of colorectal cancer (CRC), even though the contribution of Smad7 in colon carcinogenesis is not fully understood. In this study, we assessed the expression and role of Smad7 in human and mouse models of sporadic CRC. We document a significant increase of Smad7 in human CRC relative to the surrounding nontumor tissues and show that silencing of Smad7 inhibits the growth of CRC cell lines both in vitro and in vivo after transplantation into immunodeficient mice. Knockdown of Smad7 results in enhanced phosphorylation of the cyclin-dependent kinase (CDK)2, accumulation of CRC cells in S phase and enhanced cell death. Smad7-deficient CRC cells have lower levels of CDC25A, a phosphatase that dephosphorylates CDK2, and hyperphosphorylated eukaryotic initiation factor 2 (eIF2)α, a negative regulator of CDC25 protein translation. Consistently, knockdown of Smad7 associates with inactivation of eIF2α, lower CDC25A expression and diminished fraction of proliferating cells in human CRC explants, and reduces the number of intestinal tumors in Apc(min/+) mice. Altogether, these data support a role for Smad7 in sustaining colon tumorigenesis.

Appraising failure of surgical and percutaneous revascularization: long term outcomes from an observational registry.

AIM: Many randomized trials have compared coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) in terms of efficacy, but data comparing outcomes of patients in which these two techniques have failed are lacking. METHODS: We included patients undergoing PCI at our center between July 2002 and December 2004. Subjects were distinguished in 2 groups: those with at least one occluded or stenotic saphenous vein graft (CABG failure), and those with at least one stent with angiographically documented restenosis (PCI failure). The primary endpoint was the long-term rate of major adverse clinical events. RESULTS: Two hundred and thirthy four patients were included, with a medium follow up of 61±13 months; 134 were assigned to the CABG failure group, and 104 to the PCI failure group, sharing high rates of baseline risk factors. At long term rates of death were higher in post CABG group (22.1% vs. 9.9%; P=0.015, RR 2.24 C.I. 95% 1.14-4.40) while death rates in patients with diagnosis of diabetes mellitus (24.0% vs. 23.5%; P=0.969, RR 1.020 C.I. 95% 0.38-2.74) were not different CONCLUSION: PCI can be safely offered to both these kinds of patients: as recently demonstrated post CABG outcomes seem to be more favorable in patients with diabetes mellitus.

'Distal Doppler-guided dearterialization' is highly effective in treating haemorrhoids by transanal haemorrhoidal dearterialization.

AIM: Transanal haemorrhoidal dearterialization (THD® Doppler) is a surgical procedure involving Doppler-guided ligation of haemorrhoidal arteries to reduce arterial flow. With proximal Doppler-guided dearterialization, arterial ligation is achieved by introducing the proctoscope completely into the anal canal and lower rectum. In the present study, distal Doppler-guided dearterialization (DDD) is performed in the distal 2 cm of the lower rectum. Immediate and short-term results were evaluated. METHOD: One hundred patients with bleeding haemorrhoids, with or without muco-haemorrhoidal prolapse, underwent THD® Doppler procedure, using DDD of the haemorrhoidal arteries 2 cm above the anorectal junction. Mucopexy was performed in patients with haemorrhoidal prolapse. RESULTS: The operation time was 20 ± 7 min for dearterialization alone (10 patients), and 30 ± 10 min when mucopexy was added (90 patients). Morbidity included: transient haemorrhoidal thrombosis (two patients); urinary retention (five patients); submucosal abscess (one patient). No patient complained of faecal incontinence. At a median follow-up of 7.3 (3-17) months, all patients reported an improvement in symptoms. No patients reported bleeding. CONCLUSION: DDD of the haemorrhoidal arteries could be a simplified and more effective method of applying THD.

Gore Bio-A® Fistula Plug: a new sphincter-sparing procedure for complex anal fistula.

AIM: The surgical treatment of a complex anal fistula remains controversial, although 'sphincter-saving' operations are desirable. The Gore Bio-A® Fistula Plug is a new bioprosthetic plug that has been proposed for the treatment of complex anal fistula. This study reports preliminary data following implantation of this plug. METHOD: Eleven patients with a complex anal fistula underwent insertion of Gore Bio-A® Fistula Plugs. The disc diameter and number of tubes in the plug were adapted to the fistula to allow accommodation of the disc into a submucosal pocket, and the excess tubes were trimmed. During the follow-up period, patients underwent clinical and physical examinations and three-dimensional endoanal ultrasound. RESULTS: Fistulas were high anterior transphincteric in five patients and high posterior transphincteric in six patients. All patients had a loose seton placement before plug insertion. Two, three and four tubes were inserted into the fistula plug in seven, three and one patient, respectively. The median follow-up period was 5 months. No patient reported any faecal incontinence. There was no case of early plug dislodgement. Treatment success was noted for eight (72.7%) of 11 patients at the last follow-up appointment. CONCLUSION: Implanting a Gore Bio-A® Fistula Plug is a simple, minimally invasive, safe and potentially effective procedure to treat complex anal fistula. Patient selection is fundamental for success.

Sacral nerve stimulation in faecal incontinence associated with an anal sphincter lesion: a systematic review.

AIM: The long-term results of sphincteroplasty for faecal incontinence due to an anal sphincter lesion have been disappointing. Initially sacral nerve stimulation was used only in faecal incontinence of neurogenic origin but subsequently the indications have been extended to other conditions. The aim of this review was to evaluate sacral nerve stimulation for incontinence in the presence of a sphincter defect. METHOD: The MEDLINE, Embase and Cochrane Library databases for the period between 1995 and 2011 were searched for studies in English, with no limitations concerning the study size or the length of follow-up. The major endpoints were clinical efficacy, changes in anorectal manometry and quality of life. RESULTS: Ten reports (119 patients) satisfied the inclusion criteria. The quality of the studies was low (nine were retrospective, one was prospective). All reported a lesion of the external anal and/or internal anal sphincter on endoanal ultrasound. A definitive implant was performed on 106 (89%) of the 119 patients who underwent a peripheral nerve evaluation test. The weighted average number of incontinent episodes per week decreased from 12.1 to 2.3, the weighted average Cleveland Clinic Score decreased from 16.5 to 3.8, and the ability to defer defaecation, when evaluated, increased significantly. The features at anorectal manometry did not change. The quality of life improved significantly in almost all studies. CONCLUSION: Sacral nerve stimulation could be a therapeutic option for faecal incontinence in patients with an anal sphincter lesion. However, the quality of the published studies is low. A randomized clinical trial comparing sacral nerve stimulation with other classical surgical procedures at long-term follow-up, although beset with difficulties, should be conducted.

Novel bulking agent for faecal incontinence.

BACKGROUND: Various injectable bulking agents have been used for the treatment of faecal incontinence (FI). However, encouraging early results are not maintained over time. This study aimed to assess short- and medium-term results of a new bulking agent for the treatment of FI. METHODS: The Gatekeeper(™) prosthesis comprises a thin solid polyacrylonitrile cylinder that becomes thicker, shorter and softer within 24 h after implantation. Fourteen patients with FI underwent treatment with Gatekeeper(™) under local anaesthesia. Four prostheses were implanted in the intersphincteric space in each patient, under endoanal ultrasound guidance. Number of episodes of major FI, Cleveland Clinic FI score (CCFIS), Vaizey score, anorectal manometry, endoanal ultrasonography (EUS), health status and quality of life (Short Form 36 and Faecal Incontinence Quality of Life questionnaires) were assessed before and after treatment. RESULTS: Mean(s.d.) follow-up was 33·5(12·4) months. There were no complications. There was a significant decrease in major FI episodes from 7·1(7·4) per week at baseline to 1·4(4·0), 1·0(3·2) and 0·4(0·6) per week respectively at 1-month, 3-month and last follow-up (P = 0·002). CCFIS improved significantly from 12·7(3·3) to 4·1(3·0), 3·9(2·6) and 5·1(3·0) respectively (P < 0·001), and Vaizey score from 15·4(3·3) to 7·1(3·9), 4·7(3·0) and 6·9(5·0) respectively (P = 0·010). Soiling and ability to postpone defaecation improved significantly, and patients reported significant improvement in health status and quality of life. At follow-up, manometric parameters had not changed and EUS did not demonstrate any prosthesis dislocation. CONCLUSION: The Gatekeeper(™) anal implant seemed safe, reliable and effective. Initial clinical improvement was maintained over time, and follow-up data were encouraging.

Driving abilities in frontotemporal dementia patients.

OBJECTIVE: To evaluate driving competency and the relationship between neuropsychiatric symptoms and driving behavior in frontotemporal dementia (FTD) patients. METHODS: Fifteen patients with a diagnosis of FTD and 15 healthy controls were administered a driving simulation task. Measures of driving performance and neuropsychiatric symptoms were assessed. RESULTS: The FTD patients received more speeding tickets, ran more stop signs and were involved in more off-road crashes and collisions than the controls. The patients' overall average speed was significantly higher. Driving performance was correlated with agitated behavior. CONCLUSIONS: Behavioral changes characteristic of FTD patients have an impact on their driving skills leading to inappropriate driving behavior.