One-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study.

AIM: Sacral neuromodulation (SNM) is approved for the treatment of faecal incontinence (FI) in a two-stage technique. With standardized implantation, approximately 90% of patients undergo successful Stage I operation and proceed to a permanent implant (Stage II). The aim of this work was to explore the feasibility of SNM as a one-stage procedure and report the 24-week efficacy. METHOD: This study included patients diagnosed with idiopathic FI or FI due to an external anal sphincter defect ≤160° and one or more episodes of FI per week despite maximal conservative therapy. Patients were offered a one-stage procedure if a motor response of the external anal sphincter was achieved in three or more poles with at least one at ≤1.5 mA at lead placement. Patients were followed for 24 weeks. Their evaluation included the Wexner/St Mark's Incontinence Score, Faecal Incontinence Quality of Life score (FIQoL), a visual analogue scale (VAS) for assessing patient satisfaction and a bowel habit diary. RESULTS: Seventy-three patients with a median age of 60 years (interquartile range 50-69 years) completed this prospective study. Episodes of FI were significantly reduced at the 24-week follow-up, from 13 (8-23) at baseline to 2 (0-5) (p-value = 0002). A ≥50% reduction in the number of FI episodes was achieved in 92% of participants. The Wexner score improved significantly from 16 (14-17) at baseline to 9 (5-13) (p-value < 0.001), and the St Mark's score improved significantly from 18 (16-20) to 11 (7-16) (p-value < 0.001). All domains in the FIQoL score and VAS for patient satisfaction improved significantly following the one-stage procedure. CONCLUSION: A one-stage implantation procedure is feasible in selected patients with FI, significantly improving continence, quality of life and patient satisfaction after 24 weeks of follow-up.

Molecular differences of adipose-derived mesenchymal stem cells between non-responders and responders in treatment of transphincteric perianal fistulas.

BACKGROUND: Injection of autologous adipose tissue (AT) has recently been demonstrated to be an effective and safe treatment for anal fistulas. AT mesenchymal stem cells (AT-MSCs) mediate the healing process, but the relationship between molecular characteristics of AT-MSCs of the injected AT and fistula healing has not been adequately studied. Thus we aimed to characterize the molecular and functional properties of AT-MSCs isolated from autologous AT injected as a treatment of cryptogenic high transsphincteric perianal fistulas and correlate these findings to the healing process. METHODS: 27 patients (age 45 ± 2 years) diagnosed with perianal fistula were enrolled in the study and treated with autologous AT injected around the anal fistula tract. AT-MSCs were isolated for cellular and molecular analyses. The fistula healing was evaluated by MRI scanning after 6 months of treatment. AT-MSC phenotype was compared between responders and non-responders with respect to fistula healing. RESULTS: 52% of all patients exhibited clinical healing of the fistulas as evaluated 6 months after last injection. Cultured AT-MSCs in the responder group had a lower short-term proliferation rate and higher osteoblast differentiation potential compared to non-responder AT-MSCs. On the other hand, adipocyte differentiation potential of AT-MSCs was higher in non-responder group. Interestingly, AT-MSCs of responders exhibited lower expression of inflammatory and senescence associated genes such as IL1B, NFKB, CDKN2A, TPB3,TGFB1. CONCLUSION: Our data suggest that cellular quality of the injected AT-MSCs including cell proliferation, differentiation capacity and secretion of proinflammatory molecules may provide a possible mechanism underlying fistula healing. Furthermore, these biomarkers may be useful to predict a positive fistula healing outcome. TRIAL REGISTRATION: NTC04834609, Registered 6 April 2021. https://clinicaltrials.gov/ct2/show/NCT04834609.

A European snapshot of psychosocial characteristics and patients' perspectives of faecal incontinence-do they correlate with current scoring systems?

PURPOSE: To compare the current clinical scoring systems used to quantify the severity of symptoms of faecal incontinence (FI) to patients' subjective scoring of parameters of psychosocial well-being. METHODS: Patients referred to six European centres for investigation or treatment of symptoms of FI between June 2017 and September 2019 completed a questionnaire that captured patient demographics, incontinence symptoms using St. Mark's Incontinence score (SMIS) and ICIQ-B, psychological well-being (HADS, Hospital Anxiety and Depression Scale), and social interaction (a three-item loneliness scale). RESULTS: Three hundred eighteen patients completed questionnaires (62 men, mean age 58.7). Sixty percent of the respondents were aged under 65. Median SMIS was 15 (11-18), ICIQ-B bowel pattern was 8 (6-11) and bowel control was 17 (13-22), similar across all demographic groups; however, younger patients were more likely to experience symptoms of depression and anxiety (HADS score > 10, 65.2% of patients age < 65 vs 54.9% of those ages > = 65, p = 0.03) with lower quality of life (ICIQ-B QoL, median score 19 (14-23)) vs age > = 65 (16 (11-21) (p < 0.005)). On loneliness score 25.5% reported often feeling isolated from others. One of the most significant concerns by patients was the fear and embarrassment related to unpredictable episodes of incontinence. CONCLUSION: The SMIS remains a useful tool for quantifying incontinence symptoms but may underestimate the psychosocial morbidity associated with unpredictable episodes of incontinence. Interventions aimed at decreasing anxiety and to address feelings of disgust may be helpful for a significant number of patients requiring treatment for FI.

Long-term Experience of Magnetic Anal Sphincter Augmentation in Patients With Fecal Incontinence.

BACKGROUND: Magnetic anal sphincter augmentation is a novel technique for the treatment of patients with fecal incontinence. OBJECTIVE: The current study reports the long-term effectiveness and safety of this new treatment modality. DESIGN: This was a prospective multicenter pilot study. SETTINGS: The study was performed at 4 clinical sites in Europe and the United States. PATIENTS: The cohort included patients with severe fecal incontinence for ≥6 months who had previously failed conservative therapy and were implanted with a magnetic anal sphincter device between 2008 and 2011. MAIN OUTCOME MEASURES: Adverse events, symptom severity, quality of life, and bowel diary data were collected. RESULTS: A total of 35 patients (34 women) underwent magnetic anal sphincter augmentation. The median length of follow-up was 5.0 years (range, 0-5.6 years), with 23 patients completing assessment at 5 years. Eight patients underwent a subsequent operation (7 device explantations) because of device failure or complications, 7 of which occurred in the first year. Therapeutic success rates, with patients who underwent device explantation or stoma creation counted as treatment failures, were 63% at year 1, 66% at year 3 and 53% at year 5. In patients who retained their device, the number of incontinent episodes per week and Cleveland Clinic incontinence scores significantly decreased from baseline, and there were significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument. There were 30 adverse events reported in 20 patients, most commonly defecatory dysfunction (20%), pain (14%), erosion (11%), and infection (11%). LIMITATIONS: This study does not allow for comparison between surgical treatments and involves a limited number of patients. CONCLUSIONS: Magnetic anal sphincter augmentation provided excellent outcomes in patients who retained a functioning device at long-term follow-up. Protocols to reduce early complications will be important to improve overall results.

Ultrasound-Guided Pudendal Nerve Block at the Entrance of the Pudendal (Alcock) Canal: Description of Anatomy and Clinical Technique.

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.

Sacral nerve stimulation for faecal incontinence - efficacy confirmed from a two-centre prospectively maintained database.

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 %.

Bowel function after laparoscopic posterior sutured rectopexy versus ventral mesh rectopexy for rectal prolapse: a double-blind, randomised single-centre study.

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.

Treatment of non-IBD anal fistula.

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).

A randomised, controlled study of small intestinal motility in patients treated with sacral nerve stimulation for irritable bowel syndrome.

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).

Baseline factors predictive of patient satisfaction with sacral neuromodulation for idiopathic fecal incontinence.

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.

A randomized, controlled, crossover study of sacral nerve stimulation for irritable bowel syndrome.

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.

Outcome of sacral nerve stimulation for fecal incontinence at 5 years.

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.

Diagnosis and treatment of haemorrhoids.

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.

Complete obstetric anal sphincter tear and risk of long-term fecal incontinence: a cohort study.

BACKGROUND: Women with anal sphincter injuries have an increased risk of developing fecal incontinence despite surgical intervention. OBJECTIVE: The aim of this study was to evaluate the long-term risk of fecal incontinence after primary anal sphincter reconstruction and its impact on quality of life. DESIGN: This was a cohort study. SETTINGS: This study was performed at Aarhus University Hospital. PATIENTS: Women with complete anal sphincter rupture (exposed) from 1976 to 1991 and a control group of parous women (nonexposed) were included. MAIN OUTCOME: The primary outcomes measured were fecal incontinence, Wexner score, St Mark incontinence score, and quality of life. RESULTS: A total of 363 women were included (125 exposed and 238 nonexposed). The mean age was 50.4 years (95%CI: 49.8-51.0), with 22.2 years (95% CI: 21.7-22.6) of follow-up. At the time of follow-up, 49% of exposed women and 74% of nonexposed women were continent. Complete anal sphincter tear increases the risk of fecal incontinence twofold (relative risk = 2.00; 95%CI: 1.52-2.63). No other risk factors were identified. The mean Wexner score was 1.7 (95%CI: 1.3-2.1) vs 1.1 (95%CI: 0.7-1.4) (p = 0.02), and the mean St Mark score was 2.8 (95% CI: 2.1-3.4) vs 1.4 (95%CI: 1.0-1.9) (p < 0.001) in the exposed and nonexposed groups. Severity of fecal incontinence had a significant impact on the quality of life independent of exposure. LIMITATION: The cohort is relatively young; a short postmenopausal period limits the assessment of hormonal status and the effect of postmenopausal hormone replacement therapy. CONCLUSION: Complete obstetric anal sphincter tear increases the long-term risk of fecal incontinence twofold. When present, the severity of the incontinence symptoms is minor and the risk of incontinence for solid stool is not increased in comparison with the general population. Anal sphincter rupture is the only independent risk factor for fecal incontinence. The severity of fecal incontinence had the same impact on quality of life in both groups.

Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study.

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).

[Surgical treatment of anal fistulas in Crohn's disease]. / Kirurgisk behandling af anale fistler ved Crohns sygdom.

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.

Medium-term outcome of sacral nerve modulation for constipation.

BACKGROUND: Sacral nerve modulation has been reported as a minimally invasive and effective treatment for constipation refractory to conservative treatment. OBJECTIVE: This study aimed to evaluate the efficacy and sustainability of sacral nerve modulation for constipation in the medium term (up to 6 years) and to investigate potential predictors of treatment success. DESIGN: We performed a retrospective review of prospectively collected data. SETTINGS: The study was performed at 2 tertiary-care centers in Europe with expertise in pelvic floor disorders and sacral nerve modulation. PATIENTS: Patients were eligible if they had had symptoms of constipation persisting for at least 1 year, if conservative treatment (dietary modification, laxatives and biofeedback therapy) had failed, and if predefined excluded conditions were not present. INTERVENTION: The first phase of the treatment process was percutaneous nerve evaluation. If this was successful, patients underwent sacral nerve modulation therapy with an implanted device (tined-lead and implantable pulse generator). MAIN OUTCOME MEASURE: Follow-up was performed at 1, 3, 6, and 12 months, and yearly thereafter. Outcome was assessed with the Wexner constipation score. RESULTS: A total of 117 patients (13 men, 104 women) with a mean age of 45.6 (SD, 13.0) years underwent percutaneous nerve evaluation. Of these, 68 patients (58%) had successful percutaneous nerve evaluation and underwent implantation of a device. The mean Wexner score was 17.0 (SD, 3.8) at baseline and 10.2 (SD 5.3) after percutaneous nerve evaluation (p < .001); the improvement was maintained throughout the follow-up period, although the number of patients continuing with sacral nerve modulation at the latest follow-up (median, 37 months; range, 4-92) was only 61 (52% of all patients who underwent percutaneous nerve evaluation). The sole predictive factor of outcome of percutaneous nerve evaluation was age: younger patients were more likely than older patients to have a successful percutaneous nerve evaluation phase. LIMITATIONS: The study was limited by a lack of consistent outcome measures. CONCLUSIONS: : Despite improvement in Wexner scores, at the latest follow-up sacral nerve modulation was only being used by slightly more than 50% of the patients who started the first phase of treatment. Further studies are needed to reassess the efficacy and sustainability of sacral nerve modulation.

Postoperative issues of sacral nerve stimulation for fecal incontinence and constipation: a systematic literature review and treatment guideline.

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.

Cause-specific colostomy rates after radiotherapy for anal cancer: a Danish multicentre cohort study.

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.