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Introduction: Sphincter-sparing radiotherapy or chemoradiation (RT/CRT) have become the standard treatments for most patients with anal cancer. Unfortunately, long-term survivors often suffer from severe bowel symptoms indicating sensory dysfunction. The aim of the present study was to characterize the sensory pathways of the brain-gut axis after radiotherapy for anal cancer., Method: Cortical evoked potentials (CEPs) were recorded during repeated, rapid balloon distensions of the rectum and anal canal in 13 patients with anal cancer treated with radiotherapy or chemoradiation and in 17 healthy volunteers. Latencies and amplitudes of rectal CEPs were compared between the groups. CEPs from both rectal and anal distensions were examined using single sweep spectral band analysis to determine the relative amplitude of five spectral bands as a proxy of neuronal processing., Results: Groups were comparable by age (62.4 ± 7.8 vs 58.9 ± 8.9, p < 0.32) and gender. Patients had a mean Wexner fecal incontinence score of 5.5 (±3.8) and median LARS Score of 29 (0-39). Rectal CEP latencies were prolonged in patients (F = 11.7; p < 0.001), whereas amplitudes were similar (F = 0.003; p = 0.96). Spectral analysis of CEPs from rectal distensions showed significant differences between groups in theta (4-8 Hz), alpha (8-12 Hz), beta (12-32 Hz) and gamma (32-70 Hz) bands (all p < 0.001) and CEPs from anal distensions showed significant differences in the alpha, beta and gamma bands (all p ≤ 0.002)., Conclusion: Patients treated with RT/CRT for anal cancer have impaired ano-rectal sensory pathways and abnormal cortical processing. This may play a central role for the pathogenesis of late proctopathy., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Sphincter-sparing radiotherapy or chemoradiation are standard treatments for patients with anal cancer. The ultimate treatment goal is full recovery from anal cancer with preserved anorectal function. Unfortunately, long-term survivors often suffer from severe anorectal symptoms. The aim of the present study was to characterize changes in anorectal physiology after radiotherapy for anal cancer., Method: We included 13 patients (10 women, age 63.4 ± 1.9) treated with radiotherapy or chemoradiation for anal cancer and 14 healthy volunteers (9 women, age 61.4 ± 1.5). Symptoms were assessed with scores for fecal incontinence and low anterior resection syndrome. Anorectal physiology was examined with anorectal manometry and the Functional Lumen Imaging Probe., Results: Patients had a median Wexner fecal incontinence score of 5 (0-13) and a median LARS score of 29 (0-39). Compared to healthy volunteers, patients had lower mean (±SE) anal -resting (38 ± 5 vs. 71 ± 6, p < .001) and -squeeze pressures (76 ± 11 vs. 165 ± 15, p < .001). Patients also had lower anal yield pressure (15.5 ± 1.3 mmHg vs. 28.0 ± 2.0 mmHg, p < .001), higher distensibility, and lower resistance to flow (reduced resistance ratio of the anal canal during distension, q = 5.09, p < .001). No differences were found in median (range) rectal volumes at first sensation (70.5 (15-131) vs. 57 (18-132) ml, p > .4), urge (103 (54-176) vs. 90 (32-212), p > .6) or maximum tolerable volume (173 (86-413) vs. 119.5 (54-269) ml, p > .10)., Conclusion: Patients treated with radiotherapy or chemoradiation for anal cancer have low anal resting and squeeze pressures as well as reduced resistance to distension and flow.

Introduction: Normal tissue morbidity sets the dose limit for radiotherapy (RT) in cancer treatment and has importance for quality of life for cancer survivors. A previous study of prostate cancer patients treated with RT generated clinical data for radiation-induced morbidity measured by anorectal physiological methods and validated questionnaires. Other studies have identified genetic predictors associated with late radiation-induced morbidity outcome. We have expanded biobank material aiming to validate single nucleotide polymorphisms (SNPs) and a gene expression classifier with endpoints on patient-reported outcomes and biomechanical properties of the anorectum from our cohort matching originally published endpoints., Materials and Methods: The present cohort of prostate cancer patients was treated with RT curative intent in 1999-2007. Nine SNPs associated with late radiation-induced morbidity were tested in 96 patients (rs2788612, rs1800629, rs264663, rs2682585, rs2268363, rs1801516, rs13035033, rs7120482 and rs17779457). A validated gene expression profile predictive of resistance to radiation-induced skin fibrosis was tested in 42 patients. An RT-induced anorectal dysfunction score (RT-ARD) served as a fibrosis-surrogate and a measure of overall radiation-induced morbidity., Results: The lowest p-value found in the genotype analyses was for SNP rs2682585 minor allele (A) in the FSHR gene and the RT-ARD score with odds ratios (OR) = 1.76; 95% CI (0.98-3.17) p = .06, which was out of concordance with original data showing a protective effect of the minor allele. The gene expression profile in patients classified as fibrosis-resistant was associated with high RT-ARD scores OR 4.18; 95% CI (1.1-16.6), p = .04 conflicting with the hypothesis that fibrosis-resistant patients would experience lower RT-ARD scores., Conclusions: We aimed to validate nine SNPs and a gene expression classifier in a cohort of prostate cancer patients with unique scoring of radiation-induced morbidity. One significant association was found, pointing to the opposite direction of originally published data. We conclude that the material was not able to validate previously published genetic predictors of radiation-induced morbidity.

Background: Laparoscopic ventral mesh rectopexy for rectal prolapse has been widely used over the past decade to reduce postoperative functional bowel disorders. We aimed to compare changes in functional outcome 12 months after laparoscopic ventral mesh rectopexy versus laparoscopic posterior sutured rectopexy in patients with rectal prolapse., Methods: In this double-blind, randomised trial, consecutive patients aged 18 years or older at a single centre in Denmark with full-thickness rectal prolapse were randomly assigned (1:1) to either laparoscopic ventral mesh rectopexy or laparoscopic posterior sutured rectopexy by drawing numbers from opaque envelopes, in blocks of four for patients with or without preoperative constipation. Functional assessment was done preoperatively and 12 months postoperatively. The primary outcome was preoperative-to-postoperative change in obstructed defecation syndrome (ODS) score. Patients and those assessing the outcomes were masked to the procedure. The primary analysis was done in the per-protocol population. Safety outcomes were assessed in the entire cohort. The trial is registered with ClinicalTrials.gov, number NCT00946205., Findings: From Nov 1, 2006, to Jan 31, 2014, 75 consecutive patients were assigned to laparoscopic posterior sutured rectopexy (n=37) or laparoscopic ventral mesh rectopexy (n=38). Eight patients withdrew consent to follow-up, leaving 34 patients in the posterior sutured rectopexy group and 33 in the ventral mesh rectopexy groups for the primary analysis. The preoperative-to-postoperative reduction in ODS score was 1·97 (95% CI 0·01 to 3·93) in patients who received ventral mesh rectopexy and 2·18 (-0·14 to 4·49) in those who received posterior sutured rectopexy (difference -0·21 [-3·19 to 2·78]; p=0·890). Postoperative surgical complications of Clavien-Dindo grade II or worse were reported in one (3%) of 38 patients in the ventral mesh rectopexy group (ureteral injury resulting in urine leakage, and a psoas abscess) and one (3%) of 37 patients in the posterior sutured rectopexy group (haematoma and pelvic abscess). Two (5%) patients in the posterior sutured rectopexy group developed recurrence within 12 months compared with none in the ventral mesh rectopexy group (p=0·305)., Interpretation: Functional outcome measured by preoperative-to-postoperative change in ODS score was not significantly superior in patients who underwent ventral mesh rectopexy compared with those who had posterior sutured rectopexy. Additional, large, randomised, multicentre studies with long-term outcomes are warranted., Funding: None., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background and Objectives: Ultrasound-guided techniques for pudendal nerve block have been described at the level of the ischial spine and transperineally. Theoretically, however, blockade of the pudendal nerve inside Alcock canal with a small local anesthetic volume would minimize the risk of sacral plexus blockade and would anesthetize all 3 branches of the pudendal nerve before they ramify in the ischioanal fossa. This technical report describes a new ultrasound-guided technique to block the pudendal nerve. The technique indicates an easy and effective roadmap to target the pudendal nerve inside the Alcock canal by following the margin of the hip bone sonographically along the greater sciatic notch, the ischial spine, and the lesser sciatic notch., Methods: The technique was applied bilaterally in 3 patients with chronic perineal pain. The technique described was also used to locate the pudendal nerve within Alcock canal and inject dye bilaterally in 2 cadavers., Results: Complete pinprick anesthesia was obtained in the pudendal territory of the perineum in all 3 patients. Pain was effectively alleviated or reduced in all patients with no affection of the sacral plexus nerve branches. In the 2 cadavers, all 4 pudendal nerves were successfully targeted and colored., Conclusions: This new technique is based on easily recognizable sonoanatomical patterns. It probably implies no risk of sacral plexus blockade, and the pudendal nerve is anesthetized before any branches ramify from the main trunk. This promising new technique must be validated in future clinical trials.

Introduction: Sacral nerve stimulation (SNS) has been recognised as an effective treatment for faecal incontinence. Many unresolved questions could be answered when comparing large data-series from different centres providing prospective data., Aim: To present data, from an international two-centre SNS prospective database (SNSPD) on functional outcome and management of surgical complications in patients treated with SNS for faecal incontinence., Method: The SNSPD was designed in order to gather detailed pre- and perioperative information followed by a close follow-up in all patients undergoing SNS for bowel dysfunction. The SNSPD was open for inclusion of newly SNS implanted patients in May 2009, and closed on 31 December 2013. Two-centres Aarhus, Denmark, and Nantes, France, included and monitored all patients implanted due to bowel dysfunction according to database criteria., Results: In total, 164 faecal incontinent patients with a median follow-up of 22 (range 1-50) months were implanted. The Wexner incontinence score improved from 15 (range, 3-20) at baseline to 9 (range, 0-20) at latest follow-up (P < 0.001) and VAS impact on daily life improved from 85.5 (range, 3-100) to 20 (range, 0-100) (P < 0.001). Additional surgical intervention was required in 19.5 % during follow-up. Repositioning of the pacemaker due to pain or migration was the most common complication in 12.1 %. Infections leading to explantation occurred in 3.0 %.

Faecal incontinence, defined as the involuntary loss of solid or liquid stool, is a common problem affecting 0.8-8.3% of the adult population. Individuals suffering from faecal incontinence often live a restricted life with reduced quality of life. The present paper is a clinically oriented review of the pathophysiology, evaluation and treatment of faecal incontinence. First-line therapy should be conservative and usually include dietary adjustments, fibre supplement, constipating agents or mini enemas. Biofeedback therapy to improve external anal sphincter function can be offered but the evidence for long-term effect is poor. There is good evidence that colonic irrigation can reduce symptoms and improve quality of life, especially in patients with neurogenic faecal incontinence. Surgical interventions should only be considered if conservative measures fail. Sacral nerve stimulation is a minimally invasive procedure with high rate of success. Advanced surgical procedures should be restricted to highly selected patients and only performed at specialist centres. A stoma should be considered if other treatment modalities fail.

The course of the fistula tract in relation to the anal sphincter is identified by clinical examination under general anaesthesia using a fistula probe and injection of fluid into the external fistula opening. In the event of a complex fistula or in the case of fistula recurrence, this should be supplemented with an endoluminal ultrasound scan and/or an MRI scan. St. Mark's fistula chart should be used for the description. Simple fistulas are amenable to fistulotomy, whereas treatment of complex fistulas requires special expertise and management of all available treatment modalities to tailor the right operation to the individual patient. The given levels of evidence and grades of recommendations are according to the Oxford Centre for Evidence-based Medicine (www.cemb.net).

Introduction: Anal cancer is a rare malignancy, but during the past three decades, its incidence has increased in both sexes. Approximately 90% of anal cancers are related to human papillomavirus infection. The primary treatment for anal cancer is radiotherapy or radio-chemotherapy. This quality of life (QoL) study aimed at obtaining in-depth knowledge about patients' experiences with anal cancer and its impact on their QoL., Methods: A literature study identified topics for qualitative interviews with six anal cancer patients who had received oncological treatment and were without recurrent disease. The interviews were analysed using a medical anthroo-logical approach focusing on patients' health-related phys-ical, psycho-sexual and social QoL., Results: The participants suffered from common sequelae of anal cancer treatment, mainly ano-genital pain, reduced sphincter function and sexual dysfunction. The participants employed a number of "normalisation techniques", including dissociation from other cancer patients, delimitation of the cancer to a perceived external and peripheral body part and fast resumption of their usual activities., Conclusion: Anal sphincter dysfunction and sexual problems after radiotherapy for anal cancer may have a major impact on patients' QoL. By maintaining normalcy, patients tried to distance themselves from this tabooed cancer disease., Funding: not relevant., Trial Registration: not relevant, but approval was obtained from the Danish Data Protection Agency.

Background: Patients treated with external beam radiotherapy (EBRT) may suffer from long-term anorectal adverse effects. The purpose of the present study was to assess long-term functional and structural anorectal changes in patients previously treated with EBRT for prostate cancer and to suggest the mechanism behind the development of the adverse effects., Material and Methods: Our previously proposed RT-induced anorectal dysfunction (RT-ARD) score, developed with the intention to survey anorectal dysfunction was used to identify patients with and without anorectal symptoms. Among 309 patients surveyed with the questionnaire, we chose 23 patients with the highest RT-ARD score and 19 patients with the lowest RT-ARD score. They were investigated by multimodal rectal sensory stimulation, standard anal physiological tests. Changes of the rectal mucosa were assessed by flexible sigmoidoscopy and graded by the Vienna Rectoscopy Score (VRS)., Results: The mean follow-up time was 3.8 (range, 2.8; 8.6) years in patients with high RT-ARD and 3.8 (range, 2.6; 5.9) in patients with low RT-ARD. Endoscopic evaluation revealed higher VRS scores in patients with high RT-ARD compared to patients with low RT-ARD (p = 0.002). Patients with high RT-ARD had increased rectal sensory response to distension manifested both as volume (p = 0.006) and cross-sectional area (p = 0.04), and they had reduced maximum anal resting pressure assessed by anal manometri (p = 0.02)., Conclusions: Long-term anorectal symptoms correlate to changes in anorectal biomechanical properties and rectal mucosal injury. Our data suggests that RT-induced long-term anorectal dysfunction is multifactorial caused by injury of the rectal mucosa and the internal anal sphincter combined with increased rectal sensitivity and reduced rectal functional capacity.

Objective: To investigate whether sacral nerve stimulation reduces irritable bowel syndrome (IBS)-specific symptoms by a randomized, controlled, crossover study., Background: IBS affects 3% to 22% of the population worldwide, but most patients continue to have symptoms despite treatment., Methods: Patients included from our tertiary center had diarrhea-predominant or mixed IBS, with a minimum baseline IBS symptom score (Gastrointestinal Syndrome Rating Scale-IBS questionnaire) of 40 points reduced by a minimum of 30% during the percutaneous nerve evaluation before permanent implantation. Patients were randomized (1:1) to have the stimulator ON or OFF for 1 month and then the opposite for another month. Investigators and patients were not informed of the setting. IBS-specific symptoms and quality of life were assessed through bowel diaries and validated questionnaires. Primary endpoint was the IBS-specific symptom score., Results: Twenty-one patients were randomized. Ten were eligible for analysis in each group. IBS-specific symptom scores were significantly reduced during stimulation: the median difference in the ON-OFF group was 12 (range, -22 to 44) and in the OFF-ON group -17.5 (range, -48 to -1) (P = 0.0009). IBS-specific quality-of-life scores improved significantly during stimulation: the median difference in the ON-OFF group was 16 (range, -24 to 69) and in the OFF-ON group -42.5 (range, -77 to 0) (P = 0.0003). At 1-year follow-up, the median IBS-specific symptom score (25; range, 13-65) was significantly lower than that at baseline (62; range, 45-80) (P = 0.0001)., Conclusions: Sacral nerve stimulation significantly reduces symptoms and improves quality of life of highly selected patients with IBS.

Purpose: Sacral neuromodulation (SNM) is an established treatment for fecal incontinence (FI). A recent study from our group found that the relationship between patient satisfaction and clinical outcome is complex and does not match the traditional used success criteria. Therefore, the ability to predict patient satisfaction must be given priority. The aim of the present study is to identify baseline factors predictive of patient satisfaction, with SNM, for idiopathic FI., Methods: We analyzed data from patients treated with SNM for idiopathic FI in Aarhus, Denmark, and Maastricht, The Netherlands. A questionnaire considering self-reported satisfaction was mailed to these patients and compared to baseline characteristics. Logistic regression was used to determine the predictive value of baseline demographic and diagnostic variables., Results: In total, 131 patients were included in the analysis. Patient satisfaction with the current treatment result was reported in 75 patients. Fifty-six patients were dissatisfied with SNM treatment, after median 46 months (range 11-122) with permanent implantation. Pudendal nerve terminal motor latency (PNTML) was the solely identified predictor for long-term patient satisfaction. A subgroup univariate-logistic regression analysis showed that PNTML ≤ 2.3 ms at the side of lead implantation was a statistically significant predictor for patient satisfaction (odds ratio (OR) 2.3, 95% confidence interval (CI) 1.01-5.24, p = 0.048)., Conclusion: Baseline PNTML measurement may be predictive of long-term satisfaction with SNM therapy for idiopathic FI. Further studies are needed to confirm this result.

Background: Irritable bowel syndrome (IBS) is among the most common gastrointestinal disorders worldwide. In selected patients with severe diarrhoea-predominant or mixed IBS subtypes sacral nerve stimulation (SNS) alleviates IBS-specific symptoms and improves quality of life. The mode of action, however, remains unknown. The present study aimed to evaluate the effect of SNS on small intestinal motility in IBS patients., Methods: Twenty patients treated with SNS for severe diarrhoea-predominant or mixed IBS were included in a randomised, controlled, crossover study. The neurostimulator was turned ON or OFF for the first one month and then to the opposite setting for the next month. Gastrointestinal transit patterns were investigated with the Motility Tracking System-1 (MTS-1) at the end of each the ON and OFF period. Primary endpoint was change in the velocity of the magnetic pill within the small intestine. Statistical testing was performed with Wilcoxon's rank sum test and Fisher's exact test., Results: The median velocity of the magnetic pill through the small intestine in the fasting state was not significantly different between periods with and without SNS (Group ON-OFF: median change 0 m/h (range -1.07, 0.63), Group OFF-ON: median change 0.27 m/h (range -0.59, 1.12)) (p = 0.25). Neither, was the median velocity of the magnetic pill through the small intestine in the postprandial state significantly different between periods with and without SNS (Group ON-OFF: median change -0.13 m/h (range -0.46, 0.23), Group OFF-ON: median change 0.015 m/h (range -0.48, 0.59)) (p = 0.14)., Conclusion: Even though SNS may reduce symptoms of diarrhoea-predominant and mixed IBS, it has no detectable effect on small intestinal transit patterns., Trial Registration: Clinical.trials.gov, (NCT00919672).

Objective: This study aimed to evaluate the outcome of sacral nerve stimulation (SNS) for fecal incontinence at 5 years after implantation and to identify predictors of sustained efficacy., Background: There is a lack of knowledge about the long-term outcome of SNS for fecal incontinence., Methods: Prospectively collected data from patients who underwent implantation of an SNS device between 2001 and 2006 were reviewed., Results: One hundred and one patients were available for outcome evaluation at 5 years. Sixty of 101 patients [42.6% on intention-to-treat (ITT) and 55.6% per protocol (PP)] reported a favorable outcome, 41 patients (ITT 29.1%; PP 38.0%) reported an unfavorable outcome, of whom 24 patients (ITT 17.0%; PP 22.2%) had their device explanted or permanently switched off before 5 years. Wexner incontinence scores improved significantly from a baseline median of 16 (range 6-20) to a median of 6 (range 0-20) at 3 months (P < 0.0001), and the improvement compared with baseline was maintained throughout the 5-year follow-ups (P < 0.0001).Age was a negative predictive factor [odds ratio (OR): 0.96 each year increase, 95% confidence interval (CI): 0.92-0.99; P = 0.016]. Positive predictors included improvement of urge incontinence episodes during percutaneous nerve evaluation (OR: 10.8; 95% CI: 1.72-132; P = 0.036), improvement of incontinence scores at 6 months from baseline (OR: 6.29; 95% CI: 1.33-34.3; P = 0.025), particularly improvement of incontinence scores from 3 to 6 months (OR: 41.5; 95% CI: 3.51-811; P = 0.007). Overall, 521 reportable events were recorded from 94 patients (93.1%)., Conclusions: On an ITT analysis, 42.6% of patients reported favorable outcomes at 60 months. Patient's age, improvement of urge incontinence during PNE, and sustained efficacy during the first 6 months after implantation are some of the predictors identified.

Purpose: To develop and validate a scoring system for evaluation of long term anorectal dysfunction following radiotherapy for prostate cancer., Materials and Methods: Patients treated for prostate cancer with radiotherapy filled in questionnaires on anorectal function and quality of life. Items for the condensed anorectal dysfunction score (RT-ARD) were identified and weighted by binomial regression analysis. The score was tested in a separate patient material by receiver operating characteristic (ROC) analysis and correlations to quality of life domains., Results: A total of 309 patients participated in the study. The items selected were "incontinence for solid stool", "ability to defer defecation", "unproductive call to stool", "clustering of stool", and "mucus in stool." Patients were grouped into three categories according to the RT-ARD score; 0-8 (no RT-ARD), 9-23 (minor RT-ARD), 24-45 (major RT-ARD). ROC analyses revealed high sensitivity (91%) and specificity (85%) for major RT-ARD. The prediction model demonstrated a perfect fit in 60%, moderate fit in 36% and no fit in 4%. There was good correlation between the RT-ARD score and quality of life., Conclusions: The RT-ARD score is a validated and simple instrument for evaluation of anorectal dysfunction following radiotherapy for prostate cancer, and the RT-ARD score correlates to the patient's quality of life., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

These guidelines provide a review of diagnosis, conservative and surgical treatment of haemorrhoids with primary focus on the surgical treatment. In symptomatic hemorrhoids it is recommended, that conservative treatment is used as basic treatment regardless of grading. The vast majority of grade II haemorrhoids are treated conservatively, but surgery may be considered in a few cases with pronounced symptoms. In these cases chirurgia minor, Doppler guided dearterilization procedures or stapled haemorrhoidopexy are recommended. In grade III and IV Doppler guided dearterilization procedures, stapled haemorrhoidopexy (Grade III) or conventional Milligan Morgan haemorrhoidectomy are recommended.

Background and Objective: : Stimulation amplitude used in sacral nerve stimulation (SNS) is at or just above the sensory threshold (ST). This randomized, blinded crossover study aimed to document if stimulation at 75% or 50% of the ST would be as effective as stimulation at the ST for fecal incontinence (FI)., Method: : FI patients treated with SNS, who were satisfied with current treatment results and had a minimum symptom reduction of 75%, were eligible. Patients were randomized into 3 periods of 4-week stimulation: ST, 75% of the ST, and 50% of the ST. Patients completed a bowel habit diary and questionnaires on bowel functions and patient satisfaction at the study baseline and in each study period., Results: : Nineteen patients (18 females) with a mean follow-up of 51.7 ± 29.9 months were included from January to April 2010. The mean FI episodes per 3 weeks decreased from pre-SNS therapy 33.6 ± 31.6 to 1.1 ± 2.2 at the study baseline (P < 0.001). Decreasing the stimulation amplitude to as low as 50% of the ST did not affect the overall number of incontinent episodes (P = 0.078). The Wexner incontinence score dropped from 16.5 ± 2.5 for pre-SNS therapy to 7.4 ± 3.1 at the study baseline (P < 0.001). Decreasing the stimulation amplitude to ST, 75% of the ST or 50% of the ST, did not change the Wexner score when compared with the study baseline (P = 0.581). In general, patient satisfaction was high at the study baseline and did not deteriorate as the stimulation amplitude was decreased to 50% of the ST (P = 0.932)., Conclusions: : Subsensory stimulation as low as 50% of the ST is as effective as stimulation at or above the ST. The study was approved by the Regional Committee on Biomedical Research Ethics, Denmark, and registered at ClinicalTrials.gov (NCT01130870).

The treatment of transsphincteric anal fistulas in Crohn's disease is a balance between the elimination of the sepsis and the functional outcome. Loose setons can be used as a preoperative drainage or chronic treatment. Fibrin glue and the anal fistula plug are methods with excellent functional outcomes, but the success rate varies. The endorectal advancement flap is considered to be the gold standard. Ligation of the intersphincteric fistula tract is promising. Proctectomy or proctocolectomy in combination with transposition flaps may be necessary. A success rate of 66-70% has been reported.

Background: There is a lack of knowledge on the incidence and management of suboptimal therapeutic effect and the complications associated with sacral nerve stimulation for fecal incontinence and constipation., Objective: This study aimed to review current literature on postoperative issues and to propose a treatment algorithm., Data Source: PubMed, MEDLINE, and EMBASE were searched using the keywords "sacral nerve stimulation," "sacral neuromodulation," "fecal incontinence," and "constipation" for English-language articles published from January 1980 to August 2010. A further search was conducted on a wider literature using the keywords "complication," "adverse effect," "treatment failure," "equipment failure," "infection," "foreign-body migration," "reoperation," "pain," and "algorithm.", Study Selection: Four hundred sixty-one titles were identified, and after a title and abstract review, 135 were subjected to full article review; 89 were finally included in this review. Five articles were added by manual search and consensus., Results: Forty-eight studies were identified as cohort studies reporting on postoperative issues, including 1661 patients who underwent percutaneous nerve evaluation and 1600 patients who proceeded to sacral nerve stimulation therapy. Pooled data showed that the most common problem during percutaneous nerve evaluation was lead displacement (5.3%). The incidence of suboptimal outcome, pain, and infection after implantation was 12.1%, 13.0%, and 3.9%., Limitations: There was significant underreporting of untoward events, because 60% of the studies did not report complications during percutaneous nerve evaluation, and suboptimal outcome after implantation was not disclosed in 44% of the studies., Conclusions: The incidence of untoward events associated with sacral nerve stimulation appears to be low. However, there is a significant underreporting of the incidence. Using the information from the structured and systematic literature review, we formulated a clinically relevant guideline for reporting and managing postoperative issues. The guideline can provide a framework for clinical practice.

Purpose: In anal cancer, colostomy-free survival is a measure of anal sphincter preservation after treatment with radiotherapy or chemoradiotherapy. Failure to control anal cancer and complications of treatment are alternative indications for colostomy. However, no data exist on cause-specific colostomy rates. We examined this in a cohort study., Patients and Methods: Through national registries and review of medical records, we identified patients with anal cancer diagnosed from 1995 to 2003 who had curative-intent radiotherapy or chemoradiotherapy in four Danish centers. We computed cumulative incidence of tumor-related colostomy and therapy-related colostomy, treating colostomy and death as competing events. Follow-up started at completion of radiotherapy and continued throughout 2008. We used competing risk regression to compute hazard ratios (HRs) to compare the cumulative incidence of cause-specific colostomies between age, sex, tumor size, chemotherapy, and local excision before radiotherapy., Results: We included 235 patients with anal cancer. The 5-year cumulative incidences of tumor-related and therapy-related colostomy were 26% (95% CI, 21% to 32%) and 8% (95% CI, 5% to 12%), respectively. Tumor size greater than 6 cm versus less than 4 cm was a risk factor for tumor-related colostomy (adjusted HR, 3.8; 95% CI, 1.7 to 8.1), and local excision before radiotherapy was a risk factor for therapy-related colostomy (adjusted HR, 4.5; 95% CI, 1.5 to 13.5)., Conclusion: After curative-intent radiotherapy or chemoradiotherapy, one third of patients had a colostomy, of which one third were related to therapy. Large tumor size was associated with a higher risk of tumor-related colostomy, whereas history of prior excision was associated with an increased incidence of therapy-related colostomy.

Faecal incontinence should primarily be managed in a conservative way, and if this is not sufficient different options for minimally invasive surgery should be considered. Dietary regimens, fibers, constipating agents, enemas, biofeedback and colonic irrigation may be tried as first-line therapy. Posterior tibial nerve stimulation and injections of bulging agents can be offered, but the evidence is still not convincing. Sacral nerve stimulation is a well documented treatment for faecal incontinence. Magnetic anal sphincter implantation should be considered only in highly selected patients.

Purpose of Review: Anorectal dysfunction constitutes a major problem in patients surviving rectal cancer. In this review, the current options for management of fecal incontinence after treatment for rectal cancer are discussed., Recent Findings: First line therapy should be conservative measures aimed at symptomatic control. Dietary regiments, fibers, constipating agents and enemas may be tried. Biofeedback is an option to strengthen the external anal sphincter, improve rectal sensitivity and coordinate pelvic floor muscles. Colonic irrigation has been successful to reduce symptoms and improve quality of life. Surgical interventions may be considered if conservative management fails. Sacral nerve stimulation is a successful minimal invasive procedure for the treatment of fecal incontinence; however, evidence of the method after treatment for rectal cancer is still limited. Complex surgical procedures should be limited to only highly selected patients. A stoma should be considered when other treatment modalities have failed., Summary: Systematic evaluation of the postoperative anorectal function in patients treated for rectal cancer should be a standard practice at every follow-up. An individually tailored treatment should be offered to the severely affected patients to minimize their symptoms. The evidence on the most commonly used treatments is sparse, therefore, further randomized controlled studies are needed.

Objective: This study aimed to test the hypothesis that sacral nerve stimulation affects afferent vagal projections to the central nervous system associated with frontal cortex activation in patients with fecal incontinence., Patients: Nine women and one man received temporary sacral nerve stimulation with permanent electrodes as a treatment for fecal incontinence., Interventions: We used positron emission tomography to record indices of regional cerebral blood flow before and after 30 minutes of continuous stimulation. We repeated this procedure after 2 weeks of continued stimulation, before and 30 minutes after arrest of the stimulation., Results: The initial stimulation activated a region of the contralateral frontal cortex that normally is active during focused attention. After 2 weeks of stimulation, this activation had been replaced by activity in parts of the ipsilateral caudate nucleus, a region of the brain thought to be specifically involved in learning and reward processing., Conclusions: Sacral nerve stimulation induces changes in cerebral activity consistent with an effect on afferent projections of the vagus. The initial activation of the frontal cortex may reflect focused attention, whereas the subsequent activation of the caudate nucleus may reflect recruitment of mechanisms involved in learning and reward processing. These changes may contribute to the improved continence, which is an acquired result of the stimulation.

Background: Complex fistulas and persistent perineal sinuses as a result of perianal Crohn's disease remain a major therapeutic challenge. A muscle transposition may promote wound healing by filling the perineal cavity and increasing tissue oxygenation. We aimed to evaluate the outcomes of the treatment at our institution over 8 years., Methods: A retrospective review was performed for patients who underwent gracilis muscle transposition for complex perianal Crohn's disease between 1999 and 2007. Data collected included patients' demographic data, previous treatments (medical and surgical), and outcome of the operation. A structured telephone interview was conducted to evaluate medium- to long-term outcomes of the treatment., Results: Eighteen patients (8 men and 10 women, median age 33 years, range 17-59 years) underwent a gracilis muscle transposition between 1999 and 2007. Fourteen patients had a complex fistula, and 4 patients had a persistent nonhealing perineal sinus. Gracilis muscle transposition healed the perineum of 11 patients (61%) at a median follow-up of 10 months (range 1-88 months). The success rate for complex fistulas was 64% and that for persistent nonhealing perineal sinuses was 50%. Eight graft site infections and delayed healing were noted. There were no donor-site problems or major complication. Healing was maintained in 8 of 9 patients who were available for medium- to long-term follow-up (median 64 months, range 23-123 months), with high patient satisfaction., Conclusions: Gracilis transposition is a viable option as a treatment for complex perianal Crohn's disease. Efficacy was maintained in nearly 90% of patients in the medium to long term.

Background: Faecal incontinence (FI) after radiotherapy is a known phenomenon, but has received little attention to date. This article aimed to review current knowledge on faecal incontinence related to radiotherapy for prostate cancer., Methods: PubMed was searched for English-language articles published from January 1966 to December 2009 using the primary keywords 'faecal incontinence', 'prostate cancer' and 'radiotherapy'. Prospective, retrospective and controlled trials reporting FI as a complication of radiotherapy for prostate cancer were included. The retrieved titles and abstracts were screened permissively and evaluated as to whether they satisfied the predefined inclusion and exclusion criteria., Results: Nine hundred and ninety four articles were identified from the search. After step-wise review, 213 papers were selected for full article review of which 40 were selected for this review. The incidence of faecal incontinence following radiotherapy for prostate cancer varied from 1.6% to 58%. The mechanism of faecal incontinence was not entirely clear but it is most likely due to injury to the nerve plexus of the rectal muscular layer. Correlation between rectal dose-volume parameters and incidence is equivocal, although some studies suggest parameters confined to the lower rectum and/or anal canal may be of value to predict the extent of the injury and could be used as constraints in the dose planning process., Conclusions: Interpretation of data is limited due to lack of large cohort studies with data on pre-treatment continence status and because variable instruments have been used to assess the severity of the condition. Well-designed prospective studies are needed to investigate dosimetric parameters focusing on the anal canal and sphincter apparatus. Considering the spatial distribution of radiation to the rectum may identify a more direct linkage between radiation damage and faecal incontinence., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Temporary sacral nerve stimulation for faecal incontinence caused by pelvic radiation injuries was successful in 7 of 13 patients (54%). The improvement of total incontinence episodes during the temporary stimulation period was a median of 83% (range 25-93%). This may be a viable treatment option for radiation-induced faecal incontinence., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Purpose: Sacral nerve stimulation is an emerging treatment for patients with severe constipation. There has been no substantial report to date on suboptimal outcomes and complications. We report our experience of more than 6 years by focusing on incidents and the management of reportable events., Methods: A retrospective review was performed on patients who underwent sacral nerve stimulation for constipation between August 2002 and September 2008. Collected data included patients' demographic data, type and management of suboptimal outcomes and complications, and stimulation parameters at the time of reportable events., Results: Thirty-eight patients (32 women; mean age, 45.6 y; SD, 11.8; range, 21-66) received a permanent stimulator after a successful test period. The mean treatment duration was 25.7 months (SD, 20.4; range, 0-70). Twenty-two patients (58%) experienced at least one reportable event attributable to the treatment. The total of 58 reportable events were noted, including lack or loss of efficacy, pain, and undesired change of sensation. Reprogramming successfully managed 28 reportable events (48%), 19 events (33%) required surgical interventions, and 3 adverse events led to discontinuation of the treatment., Conclusions: Nearly 60% of patients who received sacral nerve stimulation for constipation experienced at least one reportable event. Although the events were often resolved by reprogramming, more than one-third required surgical intervention or discontinuation of therapy. Patients undergoing sacral nerve stimulation for constipation need to be informed of these possibilities. A systematic assessment is needed to identify the cause and optimize the management of reportable events.

The organization and infrastructure of clinical research in Denmark is currently in focus due to an ongoing review of Clinical Science performed by the National Ministry of Health. This review describes the background and philosophy for the integration of clinical research into practice and vice versa. This process is catalyzed by activities within the clinical research unit and the foundation is the clinical databases and biobanks. Understanding these mechanisms is fundamental for the quality of care in the Danish health care system and needs a national supportive strategy.

Purpose: Sacral nerve stimulation is one of many new surgical modalities for fecal incontinence. Short-term results from sacral nerve stimulation have been more encouraging than those from other modalities. The aim of this study was to report the outcome of percutaneous nerve evaluation tests and sacral nerve stimulation for the treatment of fecal incontinence from a single center covering a period of 6 years since the procedure was introduced., Methods: All of the candidates for a percutaneous nerve evaluation test and sacral nerve stimulation seen at our anal physiology unit between March 2001 and March 2007 were included in the study., Results: A total of 177 patients with fecal incontinence (160 females), median age 59.5 (range, 27-88) years, underwent a percutaneous nerve evaluation test. Of these patients, 142 (80%) had a positive test, including 21 of 25 (84%) patients who required a repeat percutaneous nerve evaluation test. Because of a functional failure, 16 patients underwent a revision of the permanent electrode, 7 of whom (44%) were satisfied with the functional result after the revision. Of 126 patients, 15 (12%) have undergone an explantation, with an infection rate of only 1.6%. Overall, after a median follow-up of 24 (range, 3-72) months, the median Wexner incontinence score decreased from 16 (range, 6-20) to 10 (range, 0-20) (P < .0001). In the 10 patients who underwent at least 6 years of treatment, the effect was sustained, as the median Wexner incontinence score decreased from 20 (range, 12-20) to 7 (range, 2-11) (P < .0001)., Conclusion: Sacral nerve stimulation is a simple, safe, and minimally invasive technique with low morbidity and excellent results, which appear to be maintained for the first 6 years after the procedure. For patients who underwent the treatment, median Wexner incontinence score decreased significantly after a median follow-up of 24 (range, 3-72) months. Twelve percent were explanted. The infection rate was 1.6%.

Introduction: Sacral nerve stimulation has become an established treatment for patients with fecal incontinence. However, the mechanism of its action remains obscure. We aim to assess whether sacral nerve stimulation improves patients' ability to retain rectal content., Methods: Patients who had been treated successfully with sacral nerve stimulation underwent four retention tests during which the stimulator was turned either on or off. Both the patients and investigators were blinded to the status of the stimulator. The retention test results were assessed for interassessment agreement and for any differences between the on and off phases. Wexner scores, anorectal physiology tests, and patients' perceptions of stimulator settings were also recorded., Results: Nineteen patients (16 women; mean age, 57.5 years) took part in the study. Retention tests showed moderate interassessment agreement (weighted Cohen's kappa index, 0.45). There were no sharp differences in retained volume between the stimulator's on and off phases (median 50 (range, 0-300) mL vs. 50 (range, 0-300) mL; P = 0.85)., Conclusion: Sacral nerve stimulation does not alter patients' ability to retain rectal content. Further studies are needed to investigate the mechanism of sacral nerve stimulation.

Purpose: This study was designed to evaluate the effect of temporary sacral nerve stimulation in patients with diarrhea-predominant irritable bowel syndrome., Methods: Symptoms of diarrhea-predominant irritable bowel syndrome and disease-specific quality of life was evaluated in six patients before and during percutaneous sacral nerve evaluation test. Primary end points were differences between total irritable bowel syndrome symptom score and total quality of life score before and during stimulation. Secondary end points were differences between the variable domains., Results: Percutaneous sacral nerve evaluation test was performed in five women and one man (median age, 33 (range, 26-54) years). The irritable bowel syndrome symptom score decreased from 48.9 to 28.3 (P = 0.004). Pain, bloating, and diarrhea were significantly reduced from 7.9, 13.5, and 17.3 to 4.4, 7.2, and 10.6, respectively (P = 0.02, P = 0.01, P = 0.03). The irritable bowel syndrome quality of life score decreased from 99.3 to 59.6 (P = 0.009). Daily activities, emotional distress, eating habits, and fatigue were significantly reduced from 26.9, 22.2, 15.2, and 23.2 to 16.9, 13.3, 8, and 14.4, respectively (P = 0.02, P = 0.02, P = 0.02, P = 0.007). Two weeks after cessation of stimulation, the patients had symptoms as before stimulation., Conclusions: Temporary sacral nerve stimulation provides a significant reduction in diarrhea-predominant irritable bowel symptoms and improves quality of life. Further studies with permanent implantation and double-blind crossover ON-and-OFF-stimulation to evaluate the impact of placebo effect are needed.

Purpose: Adjuvant radiotherapy in the treatment of rectal cancer has been shown to increase long-term morbidity causing severe anorectal dysfunction with physiologic changes whose interaction remains poorly understood. This study examines long-term anorectal morbidity from adjuvant postoperative radiotherapy., Methods: In a prospective study, patients with Dukes B or C rectal carcinoma were randomized to postoperative radiotherapy or no adjuvant treatment after anterior resection. The long-term effect of radiotherapy on anorectal function in a subset of surviving patients was assessed from a questionnaire on subjective symptoms and from physiology laboratory evaluation and flexible sigmoidoscopy., Results: Twelve of 15 patients (80 percent) treated with radiotherapy had increased bowel frequency compared with 3 of the 13 patients (23 percent) who did not have radiation therapy (P = 0.003). The former group had loose or liquid stool more often (60 vs. 23 percent, P = 0.05), had fecal incontinence more often (60 vs. 8 percent, P = 0.004), and wore pad more often (47 vs. 0 percent, P = 0.004). They also experienced fecal urgency and were unable to differentiate stool from gas more often. Endoscopy revealed a pale and atrophied mucosa and telangiectasias in the irradiated patients. Anorectal physiology showed a reduced rectal capacity (146 vs. 215 ml, P = 0.03) and maximum squeeze pressure (59 vs. 93 cm H2O, P = 0.003) in the radiotherapy group. Impedance planimetry demonstrated a reduced rectal distensibility in these patients (P < 0.0001)., Conclusions: Adjuvant postoperative radiotherapy after anterior resection causes severe long-term anorectal dysfunction, which is mainly the result of a weakened, less sensitive anal sphincter and an undistensible rectum with reduced capacity.

Radiotherapy of malignancies in the pelvis is associated with both early and late intestinal reactions with subsequent alterations in rectal function because this part of the intestine often is included in the radiation field. This report presents data on morphometry of the zero-stress and no-load states as well as residual strains and opening angles of the rectum in mice with early and late radiation injury and in age-matched sham-irradiated control groups. In blood vessels and esophagus, cross-sections at the zero-stress state are not closed rings, but open sectors. The rectal zero-stress state is demonstrated by cutting the rectum into rings and cutting the rings into sectors; each sector is characterized by an opening angle. The opening angle was between 50 degrees and 200 degrees and differed between groups (P < 0.01). Young mice had 25-50% smaller opening angles than the older mice. The irradiated groups had 25-75% smaller opening angles than the normal groups. The residual strain analysis showed mucosal compression and serosal tension in the no-load state. Both at the serosal and mucosal surfaces, variation was found between groups (P < 0.01). The no-load state wall thickness-to-mucosal circumferential length ratio varied along the axis of the organ (P < 0.01) and between groups (P < 0.01). The early irradiated group had higher values than the control group. Furthermore, proximal to the irradiated zone the late irradiated group had significantly higher values compared to the normal group, indicating a higher stress level proximal to the irradiated zone. The zero-stress state must be taken into account when studying pathophysiological problems in which the stresses and strains are important, eg, the storage function of the rectum. Radiation therapy and age remodeled the morphometry and zero-stress state of rectum.

The aim of the present study was to assess and quantify changes in the structural components of the rectal wall after irradiation with varying single doses of x-rays. A total of 70 CDF1/Bom male mice were irradiated at a selective 1.5 cm of the distal rectum with varying single doses of 0-30 Gy. At 32 weeks postirradiation the mice were sacrificed and the rectum was removed. Sampling of the specimens was based on unbiased stereological principles using systematic random sampling. Vertical tissue sections were used to estimate mucosal surface area density and to measure the thickness and volume fraction of the different intestinal wall layers. The surface area density decreased with increasing dose (p<0.02) due to pronounced injury of the crypts and mucosal morphology. The thickness and the volume fraction of the submucosa were significantly increased in the 20, 25 and 30 Gy treatment groups (p<0.0001 and p<0.0001), whereas the thicknesses of the mucosa, the lamina muscularis propria and the serosa did not change after irradiation. It is concluded that irradiation causes histopathological changes in the rectal mucosa and submucosa, and changes in the thickness of the submucosal intestinal layer. These changes were found to be dose-dependent.

Phantom breast syndrome following mastectomy has been reported by other authors. However, the temporal course, character and extent of this phenomena have not been elucidated. In a prospective study we have investigated the incidence, clinical picture and temporal course of phantom breast syndrome. One hundred and twenty women who started postoperative control or treatment at the Oncology Department over a one-year period were interviewed by a standard questionnaire three weeks after the operation. One year later 110 patients and six years later 68 patients were interviewed again. The incidence of phantom pain and non-painful phantom sensations was respectively 13.3% and 15.0%, respectively three weeks after the mastectomy. 12.7% and 11.8% after one year, and 17.4% and 11.8% after six years. A significant relationship between preoperative pain and phantom breast syndrome was found, but neither age, cancer treatment or postoperative sequelae seemed to affect the occurrence of phantom breast syndrome. Scar pain was found to persist in 30.9% of the patients six years after the operation. The present incidence of phantom-related phenomena is close to the incidence reported by others. However, persistent phantom pain after mastectomy may be more common than usually expected. Also, the persistence of scar pain seems to be more common than generally expected.

Unlabelled: Phantom breast syndrome after mastectomy has already been reported by us and other authors. The temporal course, character, and extent of these phenomena, however, have not yet been elucidated., Objective: To investigate in a prospective study the incidence, clinical picture, and temporal course of phantom breast syndrome during a 6-year period., Design: One-hundred twenty women who embarked on consecutive postoperative control or treatment at our department during a 1-year period were interviewed by a standard questionnaire 3 weeks after the operation. Of these, 110 patients were interviewed 1 year later and 69 were interviewed again 6 years later., Patients: The median age at the first interview was 54 years (Quartile (Q)1 = 45 years; Q3 = 62 years) and at the third interview 6 years later, 60 years (Q1 = 51 years; Q3 = 68 years)., Results: The incidence of phantom pain and nonpainful phantom sensations was 13.3% and 15.0%, respectively, 3 weeks after mastectomy, 12.7% and 11.8%, respectively, after a year, and 17.4% and 11.8%, respectively, after 6 years. We found significant relationships between preoperative pain and phantom breast syndrome, but no significant relationship between age and the occurrence of this syndrome. Neither postoperative sequelae nor cancer treatment including radiotherapy seemed to affect the occurrence of phantom breast syndrome. Pain in the scar, which was clearly distinguishable from phantom pain, was present in 35.0% of the patients 3 weeks postoperatively, in 22.7% after 1 year, and persisted in 30.9% 6 years later., Conclusions: The present incidence of phantom-related phenomena is close to the incidence reported by others. However, persistent phantom pain after mastectomy may be more common than usually expected. Also, the persistence of pain in the scar seems to be more common than generally expected.

The frequency of recurrent abdominal pain (RAP) was investigated in a material of 664 Danish schoolchildren. 15% of the children aged 9-12 years had RAP, defined as at least three episodes of abdominal pain during a period of three months with pain of an intensity which affected the behavior of the child. In general, there was no significant difference in the frequency of RAP in boys and girls in the material, however, a preponderance of girls with RAP after the age of ten years was found. The investigation showed that symptoms such as headache, limb pains and diarrhoea were experienced more frequently among children with RAP. In general, RAP occurred more frequently among children in families with high frequencies of psychosomatic symptoms. 40% of all the children questioned lived in broken homes. A tendency to increased frequency of RAP was found among these children. Children who lived in a garden city had essentially lower frequencies of RAP than children from other areas. There was an evident preponderance of children with RAP in families who lived in flats. There was no significant difference in the school and occupational education of the parents and the frequency of RAP.