Efficacy of biofeedback plus transanal stimulation in the management of pelvic floor dyssynergia: a randomized trial.

BACKGROUND: The therapy of pelvic floor dyssynergia is mostly conservative and is based on a high-fiber diet, physical activity and biofeedback training. Our aim was to compare the outcome of biofeedback (manometric-assisted pelvic relaxation and simulated defecation training) plus transanal electrostimulation with standard therapy (diet, exercise, laxatives). METHODS: Clinical, physiologic and quality of life [patient assessment of constipation quality of life (PAC-QOL)] measures, anorectal manometry and balloon expulsion test results were collected prospectively at baseline, at the end of the treatment and 6 months after treatment. Primary outcome was the modification of the Wexner score for defecation (WS) and the obstructed defecation score (ODS). Secondary outcomes were the modifications of anorectal manometry pattern and quality of life after treatment. RESULTS: The mean WS and ODS decreased significantly in the EMG biofeedback group: The WS decreased from 16.7 ± 4 to 10 ± 3.5 p < 0.0102, and the ODS decreased from 18.3 ± 5.5 to 5.7 ± 1.8, p < 0.0001. Besides, WS and ODS did not change significantly in the control group. The PAC-QOL score improved significantly from 61 ± 8.6 to 23 ± 4.8 (p < 0.0001) in the EMG biofeedback group; otherwise, the PAC-QOL score did not change significantly in the control group. CONCLUSIONS: Biofeedback therapy plus transanal electrostimulation provided sustained improvement in bowel symptoms and anorectal function in constipated subjects with dyssynergic defecation, whereas standard therapy was largely ineffective.

Complex anal fistula remains a challenge for colorectal surgeon.

AIM: Anal fistula is a common proctological problem to both patient and physician throughout surgical history. Several surgical and sphincter-sparing approaches have been described for the management of fistula-in-ano, aimed to minimize the recurrence and to preserve the continence. We aimed to systematically review the available studies relating to the surgical management of anal fistulas. MATERIAL AND METHODS: A Medline search was performed using the PubMed, Ovid, Embase, and Cochrane databases to identify articles reporting on fistula-in-ano management, aimed to find out the current techniques available, the new technologies, and their effectiveness in order to delineate a gold standard treatment algorithm. RESULTS: The management of low anal fistulas is usually straightforward, given that fistulotomy is quite effective, and if the fistula has been properly evaluated, continence disturbance is minimal. On the contrary, high complex fistulas are challenging, because cure and continence are directly competing priorities. CONCLUSIONS: Conventional fistula surgery techniques have their place, but new technologies such as fibrin glues, dermal collagen injection, the anal fistula plugs, and stem cell injection offer alternative approaches whose long-term efficacy needs to be further clarified in large long-term randomized trials.

Chronic blockade of CB(1) receptors reverses startle gating deficits and associated neurochemical alterations in rats reared in isolation.

BACKGROUND AND PURPOSE: Pharmacological interventions aimed at restoring the endocannabinoid system functionality have been proposed as potential tools in the treatment of schizophrenia. Based on our previous results suggesting a potential antipsychotic-like profile of the CB(1) receptor inverse agonist/antagonist, AM251, here we further investigated the effect of chronic AM251 administration on the alteration of the sensorimotor gating functions and endocannabinoid levels induced by isolation rearing in rats. EXPERIMENTAL APPROACH: Using the post-weaning social isolation rearing model, we studied its influence on sensorimotor gating functions through the PPI paradigm. The presence of alterations in the endocannabinoid levels as well as in dopamine and glutamate receptor densities was explored in specific brain regions following isolation rearing. The effect of chronic AM251 administration on PPI response and the associated biochemical alterations was assessed. KEY RESULTS: The disrupted PPI response in isolation-reared rats was paralleled by significant alterations in 2-AG content and dopamine and glutamate receptor densities in specific brain regions. Chronic AM251 completely restored normal PPI response in isolated rats. This behavioural recovery was paralleled by the normalization of 2-AG levels in all the brain areas analysed. Furthermore, AM251 partially antagonized isolation-induced changes in dopamine and glutamate receptors. CONCLUSIONS AND IMPLICATIONS: These results demonstrate the efficacy of chronic AM251 treatment in the recovery of isolation-induced disruption of PPI. Moreover, AM251 counteracted the imbalances in the endocannabinoid content, specifically 2-AG levels, and partially reversed the alterations in dopamine and glutamate systems associated with the disrupted behaviour. Together, these findings support the potential antipsychotic-like activity of CB(1) receptor blockade. LINKED ARTICLES: This article is part of a themed section on Cannabinoids. To view the other articles in this section visit http://dx.doi.org/10.1111/bph.2012.167.issue-8.

Focus on abdominal rectopexy for full-thickness rectal prolapse: meta-analysis of literature.

BACKGROUND: Laparoscopic rectopexy to treat full-thickness rectal prolapse has proven short-term benefits, but there are few long-term follow-up and functional outcome data available. Using meta-analysis techniques, this study was designed to evaluate long-term results of open and laparoscopic abdominal procedures to treat full-thickness rectal prolapse in adults. METHODS: A literature review was performed using the National Library of Medicine's PubMed database. All articles on abdominal rectopexy patients with a follow-up longer than 16 months were considered. The primary end point was recurrence of rectal prolapse, and the secondary end points were improvement in incontinence and constipation. A random effect model was used to aggregate the studies reporting these outcomes, and heterogeneity was assessed. RESULTS: Eight comparative studies, consisting of a total of 467 patients (275 open and 192 laparoscopic), were included. Analysis of the data suggested that there is no significant difference in recurrence, incontinence and constipation improvement between laparoscopic abdominal rectopexy and open abdominal rectopexy. Considering non-comparative trials, the event rate for recurrence was similar in open and laparoscopic suture rectopexy studies and in open and laparoscopic mesh rectopexy trials. Improvement in constipation after the intervention was not statistically significant except for open mesh repair; postoperative improvement in incontinence was statistically significant after laparoscopic procedures and open mesh rectopexy. CONCLUSIONS: Laparoscopic abdominal rectopexy is a safe and feasible procedure, which may compare equally with the open technique with regard to recurrence, incontinence and constipation. However, large-scale randomized trials, with comparative, strong methodology, are still needed to identify outcome measures accurately.

Ligation of the intersphincteric fistula tract (LIFT) to treat anal fistula: early results from a prospective observational study.

BACKGROUND: Ligation of the intersphincteric tract (LIFT), a novel sphincter-saving technique, has been recently described with promising results. Literature data are still scant. In this prospective observational study, we present our experience with this technique. METHODS: Between October 2010 and April 2011, 18 patients with 'complex' fistulas underwent LIFT. All patients were enrolled in the study after a physical examination including digital examination and proctoscopy. For the purpose of this pilot study, fistulas were classified as complex if any of the following conditions were present: tract crossing more than 30% of the external sphincter, anterior fistula in a woman, recurrent fistula or pre-existing incontinence. Endpoints were healing time, presence of recurrence, faecal incontinence and surgical complications. RESULTS: Ten patients were men and 8 were women; mean age was 39 years; minimum follow-up was 4 months. Three patients required drainage seton insertion and delayed LIFT. After LIFT, 1 patient experienced haemorrhoidal thrombosis. At the end of the follow-up, 15 patients (83%) healed with no recurrence. Three patients had persistent symptoms and required further surgical treatment. We did not observe postoperative worsening of continence. CONCLUSIONS: Results from our pilot study indicate that this novel sphincter-saving approach is effective and safe for treating complex anal fistula.

New trends in nutritional status assessment of cancer patients.

BACKGROUND: Nutritional status assessment and support should be considered a valuable measure within the overall oncology strategy. Despite extensive research in the field of clinical nutrition, definite guidelines to base rational nutritional assessment and support in cancer patients are still debated. This review examines different approaches to nutritional status in cancer patients. DESIGN: The assessment of nutritional status is usually based on anthropometric measures, biochemical or laboratory tests, clinical indicators and dietary assessment. At present, body composition (BC) is rarely measured in the clinical setting because it is thought to be too unmanageable and time-consuming. However, using new technologies, the estimation of fat, lean and body fluids, that is significant in the management of nutrition therapies in oncology, has become easy. The present study evaluates the different methods of nutrition assessment today available, especially body composition (BC) measurements. Furthermore, nutrition assessment, relevance of nutritional support and choice of nutritional strategy, in surgical patients, are discussed. DISCUSSION: Given the clinical relevance of nutritional intervention in patients' quality of life, the nutritional status assessment has a key role in oncological and surgical practice and should include BC assessment in order to tailor nutritional treatment to patients' individual requirements. Furthermore, administration of the supplemented diet before and after surgery seemed to be the best strategy to reduce complications and length of hospital stay.

Anal vector volume analysis: an effective tool in the management of pelvic floor disorders.

INTRODUCTION: Different trials have investigated the role of conventional anal manometry in the diagnosis of pelvic floor disorders. The aim of the present study is to define the role and the effectiveness of vector anal manometry and vector asymmetry index scoring in the assessment of pelvic floor disorders i.e. fecal incontinence and obstructed defecation. METHODS: Between 2005 and 2007, 387 patients underwent clinical and manometric evaluation in the Department of Surgery, University Hospital Tor Vergata, Rome, Italy, and were included in the present prospective cohort study. All the patients underwent clinical examination, Wexner incontinence scoring, and anal vector manometry and were classified into three groups. Group I included patients with normal resting anal pressure values (195 patients). Groups II and III consisted of patients with resting anal pressure higher and lower than normal values, respectively (90 and 102 patients, respectively). All patients were classified into asymmetric and non-asymmetric according to the vector asymmetry index using a cut-off of 20%. We investigated the correlation between anal asymmetry and pelvic floor disorders, i.e. fecal incontinence due to sphincter injury, rectal prolapse, and obstructed defecation. RESULTS: In Group III, the number of asymmetric patients was significantly higher than non-asymmetric ones (P < 0.0001). Asymmetry values were significantly higher in group III than in groups I and II considering squeeze (P < 0.0001) or resting pressures (P < 0.0001). Furthermore, there was a statistically significant association between anal asymmetry and both anal incontinence (P < 0.0001) and rectal prolapse (P = 0.0270). No such association was found between anal asymmetry and obstructed defecation. CONCLUSION: Anal vector manometry using vector analysis of resting and squeeze pressures is complementary to endoanal ultrasonography, as it provides information on anal sphincter function and integrity. The vector asymmetry index >20% correlates with fecal incontinence due to anal sphincter lesions. Therefore, anal vector manometry may be useful as an independent method of screening for pregnant women at risk of sphincter injury and for patients undergoing anorectal surgery with risk factors for incontinence, like previous anorectal surgery or a history of two or more previous vaginal deliveries.

Reduced brachial flow-mediated vasodilation in young adult ex extremely low birth weight preterm: a condition predictive of increased cardiovascular risk?

BACKGROUND: Sporadic data present in literature report how preterm birth and low birth weight constitute the risk factors for the development of cardiovascular diseases in later life. AIM: To assess the presence of potential alterations to endothelial function in young adults born preterm at extremely low birth weight (<1000 g; ex ELBW). METHOD: Thirty-two ex-ELBW subjects (10 males [M] and 22 females [F], aged 17-28 years, mean [+/- DS] 20.1 +/- 2.5 years) were compared with 32 healthy, age-matched subjects born at term (C, 9 M and 23 F). EXCLUSION CRITERIA: 1) pathological conditions known to affect endothelial function; 2) administration of drugs known to affect endothelial function. Endothelial function was assessed by non-invasive finger plethysmography, previously validated by the US Food and Drug Administration (Endopath; Itamar Medical Ltd., Cesarea, Israel). RESULTS: Endothelial function was significantly reduced in ex-ELBW subjects compared to C (1.94 +/- 0.37 vs. 2.68 +/- 0.41, p < 0.0001). Moreover, this function correlated significantly with gestational age (r = 0.56, p < 0.0009) and birth weight (r = 0.63, p < 0.0001). CONCLUSIONS: The results obtained reveal a significant decrease in endothelial function of ex-ELBW subjects compared to controls, underlining a probable correlation with preterm birth and low birth weight. Taken together, these results suggest that an ELBW may underlie the onset of early circulatory dysfunction predictive of increased cardiovascular risk.

Haemorrhoidectomy with Ligasure vs conventional excisional techniques: meta-analysis of randomized controlled trials.

OBJECTIVE: To compare the use of LigaSure devices with conventional excisional techniques, circular stapling and use of Harmonic Scalpel in patients with symptomatic haemorrhoids and to review literature on LigaSure technology (Valleylab Inc. USA). METHOD: A literature review was performed using the National Library of Medicine's Pubmed Database using the keywords Ligasure, haemorrhoidectomy, vessel sealing technology. Randomized trials comparing LigaSure with other techniques of excisional haemorrhoidectomy with valid end points were reviewed in the present article and included in a quantitative meta-analysis. RESULTS: There was no significant difference in the proportion of patients cured after Ligasure haemorrhoidectomy or other excisional techniques (P > 0.05). Patients treated with LigaSure had a significantly shorter operative time (P < 0.001), postoperative pain VAS Score (P < 0.001), wound healing time and time-off from work (P < 0.001), than the patients submitted to excisional techniques. Postoperative bleeding did not significantly differ between the two groups (P = 0.056); however, the surgeons observed a reduction of intra- and postoperative bleeding using LigaSure. In comparison to the circular stapler and Harmonic Scalpel the authors found similar postoperative outcomes and a slightly favourable trend for LigaSure regarding postoperative complications, ease of handling and length of the procedure. CONCLUSION: Our meta-analysis shows that Ligasure haemorrhoidectomy is a fast procedure characterized by limited postoperative pain, short hospitalization, fast wound healing and convalescence.

A modification of primary closure for the treatment of pilonidal disease in day-care setting.

AIM: The best surgical technique for treating sacrococcygeal pilonidal disease (PD) is still controversial. We evaluated the outcome of a modified primary closure for the treatment of pilonidal sinus. METHOD: One hundred and fifty-two consecutive patients with PD, who underwent excision and primary closure under local anaesthesia according to our method, participated in this prospective study. The duration of operation and of hospitalization, postoperative pain, time to first mobilization, postoperative complications, time to resumption of work were assessed. RESULTS: The median operative time was 30 min (range: 15-40); the median postoperative pain visual analogue scale score was 1 (range 0-3). All patients were mobilized between 2 and 4 h after surgery and discharged within 10 h. Postoperative complications included eight small debridements of an infected wound (5.3%) and one case of wound dehiscence (0.6%). No recurrence was detected during a median follow-up of 22 months (range: 10-34 months). CONCLUSION: The low complication rate, near total absence of wound dehiscence, the compliance of the patients, the type of anaesthesia and the patient satisfaction makes this method effective. A randomized trial with long-term follow-up is warranted.

Botulinum toxin for recurrent anal fissure following lateral internal sphincterotomy.

BACKGROUND: The aim of the study was to evaluate the efficacy of botulinum toxin injection in the treatment of recurrent anal fissure following lateral internal sphincterotomy. METHODS: Eighty patients were treated with botulinum toxin (30 units Botox or 90 units Dysport), injected into two sites of the internal sphincter. Clinical and manometric results were recorded before and after treatment. If symptoms persisted at 2 months, the examiners could decide to re-treat the patient. The same preparation of serotype A of botulinum neurotoxin was used for reinjection. RESULTS: One month after injection there was complete healing in 54 patients (68 per cent). Eight patients (10 per cent) reported mild incontinence of flatus that had disappeared spontaneously within 2 months. At 2 months, 59 patients (74 per cent) had a healing scar. After reinjection, 11 of 21 re-treated patients reported mild incontinence to flatus that lasted for a few weeks and resolved spontaneously. Anorectal manometry at 1 month demonstrated a significant reduction in both resting anal pressure and maximum voluntary squeeze pressure (P < 0.001). There were no relapses during a mean value of 57.9 months of follow-up. CONCLUSION: Botulinum toxin is efficacious in patients with recurrent anal fissure following lateral internal sphincterotomy.

Randomized clinical trial of LigaSure and conventional diathermy haemorrhoidectomy.

BACKGROUND: The aim of this randomized prospective trial was to compare LigaSure and conventional diathermy haemorrhoidectomy. METHODS: Two hundred and eighty-four patients with grade III or IV haemorrhoids were randomized to LigaSure or diathermy (Milligan-Morgan) haemorrhoidectomy as a day-case procedure. Operating time, postoperative pain score, hospital stay, postoperative complications, wound healing time and time to return to normal activities were assessed. Thirty-four patients were lost to follow-up. RESULTS: The mean operating time for LigaSure haemorrhoidectomy was significantly shorter than that for diathermy (P = 0.011). Patients treated with LigaSure had significantly less postoperative pain (measured on a visual analogue scale; P = 0.010), a shorter wound healing time (defined as time to absence of swelling; P = 0.012) and less time off work (P = 0.010) than patients who had diathermy. Neither postoperative complications nor mean hospital stay (day-case surgery) were significantly different. CONCLUSION: LigaSure haemorrhoidectomy demonstrates simplicity, reproducibility, a low complication rate, fast wound healing, a quick return to work and reduced postoperative pain.

Randomized clinical trial comparing botulinum toxin injections with 0.2 per cent nitroglycerin ointment for chronic anal fissure.

BACKGROUND: In recent years treatment of chronic anal fissure has shifted from surgical to medical. This study compared the ability of two non-surgical treatments-botulinum toxin injections and nitroglycerin ointment-to induce healing in patients with idiopathic anal fissure. METHODS: One hundred adults were assigned randomly to receive treatment with either type A botulinum toxin (30 units Botox or 90 units Dysport) injected into the internal anal sphincter or 0.2 per cent nitroglycerin ointment applied three times daily for 8 weeks. RESULTS: After 2 months, the fissures were healed in 46 (92 per cent) of 50 patients in the botulinum toxin group and in 35 (70 per cent) of 50 in the nitroglycerin group (P=0.009). Three patients in the botulinum toxin group and 17 in the nitroglycerin group reported adverse effects (P<0.001). Those treated with botulinum toxin had mild incontinence to flatus that lasted 3 weeks after treatment but disappeared spontaneously, whereas nitroglycerin treatment was associated with transient, moderate-to-severe headaches. Nineteen patients who did not have a response to the assigned treatment crossed over to the other therapy. CONCLUSION: Although treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery for patients with chronic anal fissure, botulinum toxin is the more effective option.

Management of bladder, prostatic and pelvic floor disorders.

Since its introduction in the late 1970s for the treatment of strabismus and blepharospasm, botulinum toxin (BoNT) has been increasingly used in the interventional treatment of several other disorders characterized by excessive or inappropriate muscle contractions. Over the years, the number of primary clinical publications has grown exponentially, and still continues to increase. It has been shown that BoNT blocks cholinergic nerve endings in the autonomic nervous system but does not block non-adrenergic non-cholinergic responses mediated by nitric oxide (NO). The present paper reviews a number of recent clinical indications for urological and pelvic floor dysfunctions, such as overactive and neurogenic bladder, non-bacterial prostatitis, benign prostatic hyperplasia, chronic anal fissure, or conditions associated to hyperactivity of the puborectalis muscle during straining. These indications provide a new promising palette of indications for future usage of BoNT in clinical practice.

Outlet type constipation in Parkinson's disease: results of botulinum toxin treatment.

BACKGROUND: Constipation is one of the most common autonomic dysfunctions observed in Parkinson's disease. AIM: To investigate the efficacy of injections of botulinum toxin in improving rectal emptying in these patients. METHODS: Eighteen Parkinson's disease patients with outlet constipation were included in the study. The patients were treated with type A botulinum toxin, injected into two sites on either side of the puborectalis muscle under ultrasonographic guidance. RESULTS: Symptomatic improvement was noted in 10 patients, at 2 months evaluation. In these subjects, anorectal manometry demonstrated decreased tone during straining from 96.2 +/- 17.1 to 45.9 +/- 16.2 mmHg at 1 month evaluation (P = 0.00001) and to 56.1 +/- 10.7 mmHg at 2 months (P = 0.00001). Pressure during straining was lower than resting anal pressure at the same times in all patients. Defecography after the treatment showed improvement in anorectal angle during straining, which increased from 99.1 +/- 8.4 degrees to 121.7 +/- 12.7 degrees (P = 0.00001) at 2 months. CONCLUSIONS: Botulinum toxin injections may be a useful treatment for Parkinson's disease patients affected by outlet-obstruction constipation. The treatment is safe and simple. However, because the effects of the toxin wear off within 3 months of administration, repeated injections could be necessary to maintain the clinical improvement.

Management of bladder, prostatic and pelvic floor disorders with botulinum neurotoxin.

Since its introduction in the late 1970s for the treatment of strabismus and blepharospasm, botulinum toxin (BoNT) has been increasingly used in the interventional treatment of several other disorders characterized by excessive or inappropriate muscle contractions. The use of this pluripotential agent has extended to a plethora of conditions including: focal dystonia; spasticity; inappropriate contraction in most sphincters of the body such as those associated with spasmodic dysphonia, esophageal achalasia, chronic anal fissure, and vaginismus; eye movement disorders; other hyperkinetic disorders including tics and tremors; autonomic disorders such as hyperhidrosis; genitourinary disorders such as overactive and neurogenic bladder, non-bacterial prostatitis and benign prostatic hyperplasia; and aesthetically undesirable hyperfunctional facial lines. In addition, BoNT is being investigated for the control of the pain, and for the management of tension or migraine headaches and myofascial pain syndrome. BoNT injections have several advantages over drugs and surgical therapies in the management of intractable or chronic disease. Systemic pharmacologic effects are rare; permanent destruction of tissue does not occur. Graded degrees of relaxation may be achieved by varying the dose injected; most adverse effects are transient. Finally, patient acceptance is high. In this paper, clinical experience over the last years with BoNT in urological impaired patients will be illustrated. Moreover, this paper presents current data on the use of BoNT to treat pelvic floor disorders.

Is the chronologic age a contra-indication for surgical palliation of unresectable periampullary neoplasms?

METHODS: Early and late results of surgical palliation for unresectable periampullary neoplasms were evaluated in 24 patients older than 70 years and compared with the same results obtained from 33 younger patients. The two groups of patients were comparable, except for age. Biliary bypass associated to gastric bypass was the most common performed procedure. RESULTS: No significant differences in the results (morbidity, mortality, and outcome) were found in the two groups of patients. In addition, the results of palliative surgery in the elderly were compared with those obtained from a comparable group of 35 patients palliated with endoscopic stent insertion: surgical palliation resulted in better long-term results. CONCLUSIONS: This study provides evidence that the chronologic age is not a contra-indication for surgical palliation of periampullary neoplasms and that surgery provides a better quality of residual life.

Botulinum neurotoxin to treat chronic anal fissure: results of a randomized "Botox vs. Dysport" controlled trial.

BACKGROUND: Botulinum neurotoxin induces healing in patients with idiopathic fissure. The optimal dosage is not well established. AIM: To compare the efficacy and tolerability of two different formulations of type A botulinum neurotoxin, and to provide more evidence with regard to the choice of dosage regimens. METHODS: Symptomatic adults with chronic anal fissure were enrolled in a randomized study. The outcome of each group was evaluated clinically, and by comparing the pressure of the anal sphincters before and after treatment. RESULTS: Fifty patients received injections of 50 units of Botox formulation (group I), and 50 patients received injections of 150 units of Dysport toxin (group II). One month after injection, 11 patients in group I and eight in group II had mild incontinence of flatus. At the 2-month evaluation point, 46 patients in group I and 47 patients in group II had a healing scar. In group I patients, the mean resting anal pressure was 41.8% lower, and the maximum voluntary squeeze pressure was 20.2% lower, than the baseline value. In group II patients, the resting anal pressure and maximum voluntary squeeze pressure were 60.0 +/- 12.0 mmHg and 71.0 +/- 30.0 mmHg, respectively. There were no relapses during an average of about 21 months of follow-up. CONCLUSIONS: Botulinum neurotoxin may be considered an effective treatment in patients with chronic anal fissure. The efficacy and tolerability of the two different formulations of botulinum neurotoxin were indistinguishable.