Agreement between Opal and G-Walk Wearable Inertial Systems in Gait Analysis on Normal and Pathological Subjects.

Despite the growing use of different wearable inertial systems, increasingly diffused in clinical practice, there is still a lack of knowledge about the agreement between systems based also on different sensor configuration. Aim of the study has been the investigation of the agreement between Opal and G-Walk wearable inertial systems in gait analysis on normal and post stroke subjects. Although both systems are able to describe significant gait differences in the two populations, study results suggest that gait analysis evaluations carried out by different inertial systems does not give completely overlapping estimation about the different parameters and that this must be taken in correct account especially comparing results of clinical trials obtained by different systems and sensor's placements.

Development of a Prototype E-Textile Sock.

The aim of this work is to design and develop a sensorized sock in Electronic Textile (ET), SWEET-Sock. The device has been realized by three textile sensor placed in a specific points of plantar arch and an accelerometer unit, both embedded and connected by conductive thread. The sensors allows the acquisition of plantar pressure and acceleration signals deriving from the motion of the lower limbs. The detected biosignals have been condictionated by a voltage divider and then were acquired through a LilyPad Arduino microcontroller and transmitted using the Simblee BLE technology to a custom made mobile app. Data were afterwards uploaded through a smartphone on a dropbox cloud where a custom made MATLAB GUI platform has been developed for further digital signal processing of main biomechanical parameters of clinical interest in postural and gait analysis.

Immunopathological characterization of cryptoglandular anal fistula: a pilot study investigating its pathogenesis.

AIM: The pathogenesis of cryptoglandular anal fistula (AF) is still under debate. Tissue inflammation could play a primary role. The pathological process of epithelial mesenchymal transition (EMT) might be involved but has never been investigated. METHOD: In a prospective pilot study, 12 patients with an AF had a fistulectomy. The excised track was divided into proximal (intrasphincteric) and distal (extrasphincteric) parts which were subjected to standard histopathological examination. The cytokines IL-8 and IL-1beta were analysed as markers of inflammation, while EMT was evaluated by expression of TGF-beta, Vimentin, Zeb-1, Snail and E-cadherin. The mRNA and protein expression of these molecules was investigated by real-time PCR (RT-PCR), Western blot analysis and immunohistochemistry and was compared with that of the normal adjacent tissue. RESULTS: Chronic inflammation and granulation tissue and a stratified epithelium were evident on standard histopathological examination. The cytokine IL-8 was more expressed in the proximal than the distal part of the track (fold increase 4.34 vs 3.60), while the reverse was found for IL-1beta (fold increase 1.33 vs 2.01); both were more intensely expressed compared with the normal anal mucosa. EMT was demonstrated, in both proximal and distal parts of the track, with an increase of TGF-beta, Vimentin, Zeb-1 and Snail and a mean decrease of E-cadherin. Western blot analysis and immunohistochemistry confirmed the protein expression. CONCLUSION: The study suggests that chronic inflammation is present in cryptoglandular fistulas. The inflammatory pattern might be different in the proximal than in the distal part of the fistula track. The cytokines IL-1beta and IL-8 could play a possible role in fistula formation. The study demonstrates for the first time the potential importance of EMT in the pathogenesis of cryptoglandular AF.

Multicentre observational study of the Gatekeeper for faecal incontinence.

BACKGROUND: A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. METHODS: Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up. RESULTS: Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. CONCLUSION: Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up.

Implantation of SphinKeeper(TM): a new artificial anal sphincter.

INTRODUCTION: A new artificial anal sphincter, SphinKeeper(TM), was devised with the aim to treat fecal incontinence (FI) by implanting specifically designed self-expandable prostheses into the intersphincteric space. Preliminary data concerning the procedure feasibility and prosthesis localization at 3 months are presented. METHODS: SphinKeeper(TM) prostheses in the native state are dehydrated, thin, solid cylinder (length 29 mm, diameter 3 mm), changing their state (shorter--length 23 mm, thicker--diameter 7 mm--and softer, with shape memory) within 48 h of contact with fluids. In this study, 10 prostheses were implanted in each patient with FI under local anesthesia and under endoanal ultrasound (EAUS) guidance, into the upper-middle intersphincteric space of the anal canal by a specifically designed delivery system. EAUS was used postoperatively to assess prostheses dislocation. RESULTS: Ten patients (5 females; median age 58 years, range 20-75) were enrolled and treated with SphinKeeper(TM) implantation. Median duration of procedure (performed by endoanal ultrasound guidance) was 40 min (range 30-45). Neither intraoperative nor postoperative complications were reported after a 3-month follow-up. In one patient, a partial dislocation of a single prosthesis was documented by EAUS, causing anal discomfort which resolved after 1 week. CONCLUSION: SphinKeeper(TM) can be safely implanted in patients with FI of different etiology. Implantation was well tolerated with no dislodgment of implants at 3-month follow-up.

Fistulotomy or fistulectomy and primary sphincteroplasty for anal fistula (FIPS): a systematic review.

There is still no clear consensus about surgical treatment of anal fistulas. Fistulotomy or fistulectomy and primary sphincter reconstruction is still regarded with skepticism. The aim of this systematic review was to evaluate the evidence in the literature supporting the use of this technique in the treatment of complex anal fistulas. MEDLINE, EMBASE and Cochrane Library databases were searched for the period between 1985 and 2015. The studies selected were peer-reviewed articles, with no limitations concerning the study cohort size, length of the follow-up or language. Technical notes, commentaries, letters and meeting abstracts were excluded. The major endpoints were the technique adopted, clinical efficacy, changes at anorectal manometry and assessment of quality of life after the procedure. Fourteen reports (666 patients) satisfied the inclusion criteria. The quality of the studies was low. Some differences about the surgical technique emerged; however, after a weighted average duration of follow-up of 28.9 months, the overall success rate was 93.2 %, with a low morbidity rate. The overall postoperative worsening continence rate was 12.4 % (mainly post-defecation soiling). In almost all cases, the anorectal manometry parameters remained unchanged. The quality of life, when evaluated, improved significantly. Fistulotomy or fistulectomy and primary sphincteroplasty could be a therapeutic option for complex anal fistula. Success rates were very high and the risk of postoperative fecal incontinence was lower than after simple fistulotomy. Well-designed trials are needed to support the inclusion of this technique in a treatment algorithm for the management of complex anal fistulas.

Cauda equina syndrome: evaluation of the clinical outcome.

AIM: Cauda equina syndrome is a rare but highly impairing syndrome involving lower limbs as well as urinary, defecatory and sexual function. In the literature the most investigated sphincter dysfunction is the urinary. Bowel and sexual function are often overlooked since they become more relevant after the acute phase. PATIENTS AND METHODS: Eight consecutive male patients affected by cauda equina syndrome with sphincter dysfunction due to herniated disc disease of lumbar spine were treated between 2007 and 2009. Five patients were followed-up for at least two years. Sexual function was evaluated by IIEF-5 questionnaire; bowel function was investigated by means of clinical and instrumental investigation and manometry. RESULTS: Although little clinical improved, patients still complained severe symptoms at first year follow-up while all but one improved significantly in the following year. At two years follow-up only the patient whose cauda equina syndrome was misdiagnosed and surgically treated late respect to the onset of the syndrome, complained a persistent severe sexual and bowel dysfunction. CONCLUSIONS: Our results show that a long-term follow-up is mandatory to evaluate the real outcome of surgical managed cauda equine syndrome because short-term evaluation could be misleading about the residual capacity of late neurologic improving. Despite the relatively low number of cases evaluated, our results confirm that early diagnosing and treating the syndrome are relevant for the final outcome.

'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.

Assessment of haemorrhoidal artery network using colour duplex imaging and clinical implications.

BACKGROUND: Dearterialization should reduce arterial overflow to haemorrhoids. The purpose of this study was to assess the topography of haemorrhoidal arteries. METHODS: Fifty patients with haemorrhoidal disease were studied. Using endorectal ultrasonography, six sectors were identified within the lower rectal circumference. Starting from the highest level (6 cm above the anorectal junction), the same procedure was repeated every 1 cm until the lowest level was reached (1 cm above the anorectal junction). Colour duplex imaging examinations identified haemorrhoidal arteries related to the rectal wall layers, and the arterial depth was calculated. RESULTS: Haemorrhoidal arteries were detected in 64·3, 66·0, 66·0, 98·3, 99·3 and 99·7 per cent of the sectors 6, 5, 4, 3, 2 and 1 cm above the anorectal junction respectively (P < 0·001). Most of the haemorrhoidal arteries were external to the rectal wall at 6 and 5 cm (97·9 and 90·9 per cent), intramuscular at 4 cm (55·0 per cent), and within the submucosa at 3, 2 and 1 cm above the anorectal junction (67·1, 96·6 and 100 per cent) (P < 0·001). The mean arterial depth decreased significantly from 8·3 mm at 6 cm to 1·9 mm at 1 cm above the anorectal junction (P < 0·001). CONCLUSION: This study demonstrated that the vast majority of haemorrhoidal arteries lie within the rectal submucosa at the lowest 2 cm above the anorectal junction. This should therefore be the best site for performing haemorrhoidal dearterialization.

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.

Anorectal physiology is not changed following transanal haemorrhoidal dearterialization for haemorrhoidal disease: clinical, manometric and endosonographic features.

AIM: The effect of transanal haemorrhoidal dearterialization (THD) on continence and anorectal physiology has not yet been demonstrated. METHOD: Twenty patients suffering from 3rd degree haemorrhoids were enrolled and underwent THD, including both dearterialization and mucopexy. Clinical assessment, anorectal manometry, rectal volumetry and endoanal ultrasound were performed preoperatively and at 6 months postoperatively. RESULTS: Postoperatively two and six patients had transient rectal pain and tenesmus, respectively. No patient reported faecal urgency or minor or major incontinence. All patients remained able to discriminate gas from faeces. No significant variation of the mean values of anal manometric and rectal volumetric parameters was recorded at 6 months of follow-up compared with preoperative values. At 6 months both internal and external sphincters were endosonographically intact. CONCLUSION: THD does not cause trauma to the anal canal and rectum.

Transanal haemorrhoidal dearterialization (THD) for selected fourth-degree haemorrhoids.

BACKGROUND: Traditional treatment of fourth-degree haemorrhoidal disease (HD) is conventional haemorrhoidectomy and is frequently associated with significant pain and morbidity. In recent years, the use of transanal haemorrhoidal dearterialization (THD) for the treatment of HD has increased. The procedure aims to decrease the arterial blood flow to the haemorrhoids. Moreover, since a rectal mucopexy to treat the prolapsing component has become part of the THD technique, this treatment is also indicated for more advanced HD. The aim of this study was to assess the possible role of THD in the treatment of fourth-degree HD. METHODS: All patients with non-fibrotic fourth-degree HD were offered the THD procedure with mucopexy. Excision of skin tags was added to THD and mucopexy, when needed. A specific score was used to assess HD severity, ranging from 0 (no HD) to 20 (worst HD). The mean preoperative score was 18.1 ± 1.8. RESULTS: Thirty-five consecutive patients (mean age 50.4 ± 13.8 years; 19 men) with fourth-degree HD were prospectively enroled. An average of 6 arteries were identified and transfixed. Mucopexy was achieved with a 3-6 sector plication of rectal mucosa. Mean operating time was 33 ± 12 min. No intraoperative complications were recorded. Postoperative morbidity included 3 (8.6%) haemorrhoidal thromboses (1 requiring surgery) and 2 (5.7%) episodes of bleeding (1 requiring surgical haemostasis). Five patients (14.3%) had urinary retention requiring catheterization. At a median follow-up of 10 months (range 2-28 months), symptoms had resolved or significantly improved in 33 (94%) patients. Nine patients (25.7%) reported irregular bleeding, 3 patients (8.6%) mild anal pain, 4 patients (11.4%) transient anal burning and 4 patients (11.4%) tenesmus. Ten patients (28.6%) experienced some degree of residual prolapse, significant only in 2 (5.7%) who required further surgery. There was no anorectal stenosis, and no faecal incontinence was reported. At a median follow-up of 10 months, the symptomatic score was 2.5 ± 2.5 (P < 0.005). CONCLUSION: Transanal haemorrhoidal dearterialization seems to be a safe and effective treatment for fourth-degree HD providing a significant improvement of symptoms for the majority of patients. When present, persisting symptoms are mostly transient, occasional or limited in severity, and only a very few patients require further intervention. Larger series and longer follow-up to further assess the role of THD in this challenging group of pts.

Sacral neuromodulation in the treatment of defecation disorders.

A large number of patients present with fecal incontinence due to idiopathic pelvic neuropathy or lesions of pelvic nerves, iatrogenic or secondary to other pelvic diseases or dysfunctions, involving sacral nerves. On the other hand, in many patients, constipation could be related to a peripheral neuropathy impairing normal defecation. Sacral neuromodulation (SNM) has been demonstrated as an effective approach in neuropathic defecation disorders. Its application is usually safe and easy, with a limited rate of complications or adverse events. The surgical procedure is made under local anesthesia. SNM effectiveness can be reliably tested during a short term period (up to 30 days) before the decision for a permanent implant. Results in most series show significant clinical improvement, with reduction in the number of incontinence episodes, decrease of incontinence score and improvement in patients' quality of life. A few reports suggest a potential and interesting application of SNM in constipation. Findings from anorectal manometry and other physiology examinations are not conclusive in order to define SNM mechanisms of actions and suggest that a multifactorial effect "modulates" the deficient neuromuscular system causing the defecation disorders.