RÉSUMÉ
Clinical decision-making in the treatment of patients with obstructed defaecation remains controversial and no international guidelines have been provided so far. This study reports a consensus among European opinion leaders on the management of obstructed defaecation in different possible clinical scenarios.
Sujet(s)
Prise de décision clinique , Constipation/diagnostic , Constipation/chirurgie , Défécation , Occlusion intestinale/diagnostic , Occlusion intestinale/chirurgie , Algorithmes , Constipation/physiopathologie , Humains , Occlusion intestinale/physiopathologie , SyndromeRÉSUMÉ
BACKGROUND: The aim of the present study was to compare sacral nerve stimulation (SNS) for constipation (SNS-C) with SNS for idiopathic faecal incontinence (SNS-IFI) regarding explantation rate, additional visits, and improvement of patient satisfaction 5 years after implantation. METHODS: From our prospective database (launched in 2009), we extracted all SNS-C patients 5 years post-implantation, and the SNS-IFI patients implanted just before and just after each SNS-C patient. We retrospectively evaluated the explantation rate, number of additional visits, and patient satisfaction using a visual analogue scale (VAS). We hypothesized that compared with those in the SNS-IFI group: (1) the explantation rate would be higher in SNS-C patients, (2) the number of additional visits would be higher in SNS-C patients, and (3) in patients with an active implant at 5 years, the improvement in VAS would be the same. RESULTS: We included 40 SNS-C patients and 80 SNS-IFI patients. In the SNS-C group 7/40 (17.5%), patients were explanted, compared to 10/80 (12.5%) patients in the SNS-IFI group (p = 0.56). The mean number of additional visits in the SNS-C group was 3.5 (95% CI 2.8-4.1)) and 3.0 (95% CI 2.6-3.6)) in the SNS-IFI group (p = 0.38). Additional visits due to loss of efficacy were significantly higher in the SNS-C patients (p = 0.03). The reduction in VAS score (delta VAS) at 5 years was 37.1 (95% CI 20.9-53.3) in the SNS-C group, and 46.0 (95% CI 37.9-54.0) in the SNS-IFI group (p = 0.27). CONCLUSIONS: No significant difference was found regarding explantation rate, number of additional visits, or improvement of VAS at 5 years after SNS implantation between SNS-C patients and SNS-IFI patients.
Sujet(s)
Électrothérapie , Incontinence anale , Constipation/thérapie , Incontinence anale/thérapie , Humains , Plexus lombosacral , Satisfaction des patients , Qualité de vie , Études rétrospectives , Résultat thérapeutiqueRÉSUMÉ
BACKGROUND: Chronic non-healing wounds are a major problem after closed incision pilonidal surgery. Freshly collected autologous adipose tissue injected into perianal fistulas in patients with Crohn's disease seems to promote healing. We investigated this technique in patients with non-healing wounds after cleft-lift surgery for pilonidal sinus disease (PSD). METHOD: In a prospective interventional pilot study conducted at our institution autologous adipose tissue from the abdominal wall was harvested, and injected into chronic non-healing PS wounds after surgical revision, healing rate being the primary outcome. The wounds were left open. Patients were followed every 2 to 3 weeks until complete healing (skin coverage, no undermining). RESULTS: 7 male patients were included (mean age 24 ± 0,6 SD years) and complete healing was achieved in 6 patients (86%). Median time to healing was 90 days (range 36-403 days ) and mean follow-up time was 388± 45 days. All patients reported major symptom relief shortly after the procedure. The mean operation time was 80 ± 23 minutes and the mean amount of freshly collected adipose tissue injected was 27.4± 12 ml. There were no complications. CONCLUSIONS: Freshly collected autologous adipose tissue injected into chronic non-healing pilonidal wounds seems safe and efficient.
Sujet(s)
Sinus pilonidal , Tissu adipeux , Adulte , Humains , Mâle , Sinus pilonidal/chirurgie , Projets pilotes , Études prospectives , Résultat thérapeutique , Jeune adulteRÉSUMÉ
BACKGROUND: Bowel dysfunction is common after surgery for rectal cancer, especially when neoadjuvant radiotherapy is used. The role of sensory function in the pathogenesis remains obscure, and the aim of the present study was to characterize the sensory pathways of the brain-gut axis in rectal cancer patients treated with resection ± radiotherapy compared with healthy volunteers. METHODS: Sensory evaluation by (neo)rectal distensions was performed and sensory evoked potentials (SEPs) were recorded during rapid balloon distensions of the (neo)rectum and anal canal in resected patients with (n = 8) or without (n = 12) radiotherapy. Twenty healthy volunteers were included for comparison. (Neo)rectal latencies and amplitudes of SEPs were compared and spectral band analysis from (neo)rectal and anal distensions was used as a proxy of neuronal processing. RESULTS: Neorectal sensation thresholds were significantly increased in both patient categories (all p < 0.008). There were no differences in (neo)rectal SEP latencies and amplitudes between groups. However, spectral analysis of (neo)rectal SEPs showed significant differences between all groups in all bands (all p < 0.01). On the other hand, anal SEP analyses only showed significant differences between the delta (0-4 Hz), theta (4-8 Hz) and, gamma 32-50 Hz) bands (all p < 0.02) between the subgroup of patients that also received radiotherapy and healthy volunteers. CONCLUSIONS: Surgery for rectal cancer leads to abnormal cortical processing of neorectal sensation. Additional radiotherapy leads to a different pattern of central sensory processing of neorectal and anal sensations. This may play a role in the functional outcome of these patients.
Sujet(s)
Procédures de chirurgie digestive , Proctectomie , Tumeurs du rectum , Canal anal/chirurgie , Humains , Manométrie , Tumeurs du rectum/radiothérapie , Tumeurs du rectum/chirurgie , Rectum/chirurgieRÉSUMÉ
BACKGROUND: Fistula laser closure (FiLaC) is a novel sphincter-saving technique for the treatment of fistula-in-ano. The aim of this study was to assess the safety and efficacy of the FiLaC procedure. METHODS: Databases including PubMed/Medline, Scopus, Web of Science, and Embase were searched for articles assessing FiLaC. All studies including case series and comparative studies reporting the outcome of FiLaC in the treatment of fistula-in-ano were considered eligible. The main outcomes were healing rates of fistula laser closure, postoperative complications including incontinence, technical aspects of the procedure and failure of healing. RESULTS: Seven studies were included. There were a total of 454 patients, 69.1% with a transsphincteric fistula-in-ano and 35% with recurrent disease. The median age of the patients was 43 years (range 18-83 years). The median operation time was 18.3 min (range 6-32 min). With a median follow-up of 23.7 months, the weighed mean rate of primary healing was 67.3% and the overall success when FiLaC was reused was 69.7%. The weighted mean rate of complications was 4%, all of them were minor complications and the weighted mean rate of continence affection was 1% in the form of minor soiling. CONCLUSIONS: FiLaC may be considered an effective and safe sphincter-saving technique for the treatment of fistula-in-ano with an acceptable, low, complication rate. However, well-designed randomized control trials comparing FiLaC with other techniques are required to substantiate the promising outcomes reported in this review.
Sujet(s)
Fistule rectale , Adolescent , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Canal anal , Humains , Lasers , Adulte d'âge moyen , Durée opératoire , Complications postopératoires/épidémiologie , Complications postopératoires/étiologie , Fistule rectale/chirurgie , Résultat thérapeutique , Cicatrisation de plaie , Jeune adulteRÉSUMÉ
AIM: Sacral nerve stimulation (SNS) for faecal incontinence (FI) at subsensory amplitudes as low as 50% of the sensory threshold has been found to be effective at 3 months' follow-up. Furthermore, alternative pacemaker settings may improve functional outcome in patients with suboptimal treatment efficacy. In this work we aim to explore if sub-sensory stimulation as low as 50% of sensory threshold is effective at 1-year follow-up. We also aimed to investigate if 31 Hz (frequency) or 90 µs (pulse width) stimulation improved treatment efficacy in dissatisfied patients. METHOD: All patients in whom the stimulation was effective in controlling FI (satisfied group) were encouraged to have the stimulation amplitude reduced. Those in whom the device was less effective (dissatisfied group) were offered alternative frequency settings or pulse width (31 Hz or 90 µs). Patients were follow-up after 12 months and evaluated by a visual analogue scale (VAS) for patient satisfaction, the Cleveland Clinic Continence Score (CCCS), Rockwood Faecal Incontinence Quality of Life Scale (QoL) and a bowel habit diary. RESULTS: Two hundred and nineteen patients were contacted, with a response rate of 71% (n = 155). Those who were successfully contacted comprised 110 (71%) patients classed as satisfied and 45 (29%) as dissatisfied. Seventy-five (68%) of the satisfied patients agreed to have their stimulation amplitude reduced. At 1-year follow-up the median amplitude had reduced from 1.5 V [interquartile range (IQR) 0.85-2.0 V] to 0.75 V (IQR 0.45-1.4 V) (P-value < 0.001) representing an overall reduction of 39% (6.6-62.5%). There were no significant differences in VAS, CCCS or QoL despite subsensory stimulation at 1-year follow-up. In 28% of the dissatisfied patients alternative pacemaker settings improved VAS to satisfactory levels. CONCLUSION: Subsensory stimulation is as effective as stimulation at or above the sensory threshold. High-frequency stimulation (31 Hz) can improve functional outcome in patients with loss of efficacy.
Sujet(s)
Électrothérapie , Incontinence anale , Incontinence anale/thérapie , Études de suivi , Humains , Longévité , Plexus lombosacral , Qualité de vie , Résultat thérapeutiqueSujet(s)
Canal anal/chirurgie , Ligature/méthodes , Fistule rectale/chirurgie , Adulte , Canal anal/vascularisation , Humains , MâleRÉSUMÉ
AIM: Sacral nerve stimulation has been recognized as an effective treatment option for faecal incontinence when conservative therapy has failed. Refinement of the procedural technique and the use of a curved stylet may improve the functional outcome. Our aim was to explore the relationship between lead model, functional outcome, stimulation amplitude and the need for extra visits during the first year of follow-up. METHOD: Patient data from May 2009 to February 2017, which were prospectively collected in a local database, were extracted and analysed for differences between lead model and improvement in incontinence scores, stimulation amplitude and the need for additional visits during the first year of follow-up. RESULTS: A foramen lead model 3093(straight stylet) was used in 134 patients and lead model 3889(curved stylet) was used in 40 patients. There were no differences in baseline characteristics or incontinence scores. Comparing results between the two lead models we found that the improvement (delta value) in the Wexner score at 6 months' follow-up (P = 0.05) and the St Mark's score at 12 months' follow-up (P = 0.02) was greater in patients implanted with lead model 3889(curved stylet) compared with patients implanted with lead model 3093(straight stylet). Patients implanted with lead model 3889 (curved stylet) were less likely to have to alter the stimulation amplitude or pole configuration during the first year of follow-up (P = 0.04). No difference was found for stimulation amplitude (P = 0.170) or the need for additional visits (P = 0.663). CONCLUSION: Lead model 3889 (curved stylet) improves functional results compared with lead model 3093 (straight stylet) during the first year of follow-up. Lead model 3889 (curved stylet) reduces the need for reprogramming but has no influence on stimulation amplitude or the number of additional visits required.
Sujet(s)
Électrothérapie/instrumentation , Électrodes implantées , Incontinence anale/thérapie , Implantation de prothèse/méthodes , Nerfs spinaux , Sujet âgé , Bases de données factuelles , Femelle , Humains , Mâle , Adulte d'âge moyen , Qualité de vie , Sacrum , Résultat thérapeutiqueRÉSUMÉ
BACKGROUND: Abnormal central nervous system processing of visceral sensation may be a part of the pathogenesis behind idiopathic fecal incontinence (IFI). Our aim was to characterize brain differences in patients with IFI and healthy controls by means of structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI). METHODS: In 21 female patients with IFI and 15 female healthy controls, whole-brain structural differences in gray matter volume (GMV), cortical thickness, and white matter tracts fractional anisotropy (FA) were quantified. For this purpose, we used voxel-based morphometry, surface based morphometry and tract-based spatial statistic, respectively. Furthermore, associations between structural brain characteristics and latencies of rectal sensory evoked electroencephalography potentials were determined. KEY RESULTS: Compared to healthy controls, IFI patients had significantly reduced FA values, reflecting reduced white matter tract integrity, in the left hemisphere superior longitudinal fasciculus (SLF), posterior thalamic radiation, and middle frontal gyrus (MFG), all P<.05. No differences were observed in GMV or in cortical thickness. The reduced FA values in the SLF and MFG were correlated with prolonged latencies of cortical potentials evoked by rectal stimuli (all P<.05). CONCLUSIONS & INFERENCES: This explorative study suggests that IFI patients have no macrostructural brain changes, but exhibit microstructural changes in white matter tracts relevant for sensory processing. The clinical relevance of this finding is supported by its correlations with prolonged latencies of cortical potentials evoked by rectal stimulation. This supports the theories of central nervous system changes as part of the pathogenesis in IFI patients.
Sujet(s)
Encéphale/anatomopathologie , Incontinence anale/anatomopathologie , Substance blanche/anatomopathologie , Sujet âgé , Encéphale/imagerie diagnostique , Imagerie par résonance magnétique de diffusion , Imagerie par tenseur de diffusion , Incontinence anale/complications , Femelle , Humains , Adulte d'âge moyen , Substance blanche/imagerie diagnostiqueRÉSUMÉ
BACKGROUND: Injection of autologous fat is an established method within plastic surgery for soft tissue augmentation. The aim of the present study was to determine whether transperineal fat graft injection could promote healing of anovaginal fistulas. METHODS: The procedures were performed at the University Hospital of North Norway, Tromsø, Norway, and at Aarhus University Hospital, Aarhus, Denmark, between May 2009 and September 2016. After abdominal liposuction, fat was injected around the fistula tract that was finally transected percutaneously with a sharp cannula and fat injected between the cut parts. The internal opening was closed with a suture. Patients had a minimum follow-up of 6 months after last fat graft injection. RESULTS: Twenty-seven women underwent 48 procedures. The cause of fistula was obstetric (n = 9), abscess (n = 9), Crohn's disease (n = 7), radiation for anal cancer (n = 1) and endoscopic surgery after radiation for rectal cancer (n = 1). The mean amount of injected fat was 73 ml (SD ± 20 ml), and operating time was 63 min (SD ± 21 min). At median follow-up of 20 months (range 6-87 months) after the last injection, fistulas were healed in 21 women (77%), in 8 women after just one procedure. Healing was achieved in 6 of 7 women (86%) with Crohn's disease and in both women who had undergone radiation therapy. One woman developed an abscess and additional trans-sphincteric fistula 8 weeks after injection. CONCLUSIONS: Fat graft injection for anovaginal fistulas is effective and safe.
Sujet(s)
Injections/méthodes , /méthodes , Fistule rectovaginale/chirurgie , Graisse sous-cutanée/transplantation , Adulte , Femelle , Études de suivi , Humains , Adulte d'âge moyen , Fistule rectovaginale/étiologie , Résultat thérapeutiqueRÉSUMÉ
AIM: Our unit has recently shown that sacral nerve stimulation (SNS) has a significantly positive short-term effect on selected patients with diarrhoea-predominant or mixed irritable bowel syndrome (IBS). The aim of the present prospective study was to evaluate the medium-term efficacy of SNS for IBS to establish whether SNS could have a future role in the treatment of IBS. METHOD: Patients with IBS who had previously been implanted with a permanent neurostimulator as part of a randomized, controlled, crossover study, were assessed for medium-term follow-up. The primary end-point was change in the IBS-specific symptom score (Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome version questionnaire) from baseline to 3-year follow-up. The secondary end-point was a change in the IBS-specific quality of life score (Irritable Bowel Syndrome-Impact Scale questionnaire) from baseline to 3-year follow-up. RESULTS: Of 26 patients, 20 were eligible for 3-year follow-up. The median IBS-specific symptom score was significantly lower at 3-year follow-up (30, range 13-71) than at baseline (62, 45-80) (P = 0.0001). The effect was observed in all symptom clusters within the score. Also, the median IBS-specific quality of life score was significantly improved at 3-year follow-up (52, 26-169) compared with baseline (135, 82-180, P = 0.0002). The effect was observed in all domains of the score. As per the protocol, 75% of patients were judged therapeutic successes. Seventy per cent of patients had a more than 50% reduction in daily IBS symptoms. CONCLUSION: At medium-term follow-up, SNS continues to be an effective treatment for highly selected patients with diarrhoea-predominant or mixed IBS.
Sujet(s)
Diarrhée/thérapie , Électrothérapie/méthodes , Syndrome du côlon irritable/thérapie , Plexus lombosacral , Adulte , Diarrhée/étiologie , Femelle , Études de suivi , Humains , Syndrome du côlon irritable/complications , Mâle , Adulte d'âge moyen , Essais contrôlés randomisés comme sujet , Résultat thérapeutique , Jeune adulteRÉSUMÉ
BACKGROUND: Sacral nerve stimulation (SNS) is a well-established treatment for fecal incontinence but its mode of action remains obscure. Anal sphincter function is usually evaluated with manometry but resistance to distension may be a more appropriate parameter than luminal pressure. The functional lumen imaging probe allows detailed description of distension properties of the anal canal. Our objective in this study was to characterize the impact of SNS on distension properties of the anal canal in patients with idiopathic fecal incontinence. METHODS: We studied 10 women (median age 64 [44-79] years) with idiopathic fecal incontinence at baseline and during SNS. The luminal geometry of the anal canal was examined with the FLIP at rest and during squeeze and the distensibility of the anal canal was investigated during filling of the bag. KEY RESULTS: All patients were successfully treated with SNS and the mean Wexner Incontinence Score was reduced from 14.9 ± 4 to 7.1 ± 4.8 (P<.001). The pressure required to open the narrowest point of the anal canal during distension (yield pressure) increased from 14.5 ± 12.2 mmHg at baseline to 20.5 ± 13.3 mmHg during SNS (P<.01). The pressure-strain elastic modulus increased non-significantly from 2.2 ± 0.5 to 2.9 ± 1.6 kPa, indicating increased stiffness of the anal canal. CONCLUSION AND INFERENCES: The yield pressure and the resistance to distension increased in response to SNS for idiopathic fecal incontinence. This will inevitably increase the resistance to flow through the anal canal, which may contribute to the benefits of sacral nerve stimulation.
Sujet(s)
Canal anal/physiopathologie , Électrothérapie/méthodes , Incontinence anale/physiopathologie , Manométrie/méthodes , Sacrum/innervation , Nerfs spinaux/physiologie , Adulte , Sujet âgé , Canal anal/imagerie diagnostique , Imagerie diagnostique/instrumentation , Imagerie diagnostique/méthodes , Incontinence anale/diagnostic , Femelle , Humains , Manométrie/instrumentation , Adulte d'âge moyen , Projets pilotes , Sacrum/physiologieRÉSUMÉ
BACKGROUND: It has been suggested that the effects of sacral nerve stimulation against fecal incontinence involve neuromodulation at spinal or supraspinal levels. OBJECTIVE: This study aims to investigate the afferent sensory pathways from the anorectum before and during sacral nerve stimulation. DESIGN: This is an explorative study. PATIENTS: Fifteen women with idiopathic fecal incontinence (mean age, 58 ± 12.2 years) were selected. INTERVENTIONS: Cortical evoked potentials were recorded during repeated rapid balloon distension of the rectum and the anal canal both before and during temporary sacral nerve stimulation. Stimuli applied were individualized according to the subjective urge to defecate. MAIN OUTCOME MEASURES: The main outcomes measured were 1) stimulus intensity, 2) latencies and amplitudes of cortical evoked potentials, and 3) spectral content in predefined frequency bands of cortical evoked potentials. RESULTS: The median Wexner fecal incontinence score improved from 15.5 ± 3.6 before to 6.7 ± 5 during sacral nerve stimulation (p < 0.001). Sacral nerve stimulation did not affect the threshold for urge to defecate during rectal distension (p = 0.64) but reduced the threshold from stimulation of the anal canal by 50% (p = 0.03). No statistically significant differences were found in latencies, amplitudes, or spectral analysis. LIMITATIONS: This is a pilot study of limited size. CONCLUSIONS: In patients with idiopathic fecal incontinence, sacral nerve stimulation reduced the threshold for urge to defecate elicited from the anal canal, whereas supraspinal responses remained unaltered. This may suggest that sacral nerve stimulation, at least in part, acts via somatic afferent fibers enhancing anal sensation.
Sujet(s)
Canal anal , Incontinence anale , Plexus lombosacral/physiopathologie , Rectum , Neurostimulation électrique transcutanée/méthodes , Sujet âgé , Canal anal/innervation , Canal anal/physiopathologie , Potentiels évoqués somatosensoriels , Incontinence anale/diagnostic , Incontinence anale/physiopathologie , Incontinence anale/thérapie , Femelle , Humains , Manométrie/méthodes , Adulte d'âge moyen , , Projets pilotes , Rectum/innervation , Rectum/physiopathologieRÉSUMÉ
AIM: Sacral nerve stimulation (SNS) is effective for faecal incontinence (FI). Little is known about the relationship between the implantation technique and the functional outcome. This study aimed to explore the relationship between the numbers of active electrode poles (AEP) achieved during permanent lead placement and subsequent function, therapeutic amplitude and the need for extra appointments between scheduled follow-up visits. METHOD: One hundred and eighty-six patients with FI who underwent permanent implantation between May 2009 and March 2015 with a tined (barbed) lead (3093/3080, Medtronic) using the straight stylet were registered on the European two-centre SNS prospective database (SNSPD). Correlation between the number of AEP, function, stimulation amplitude and the need for extra visits was analysed. RESULTS: The numbers of patients having an intra-operative motor response on stimulation of one, two, three and four poles were 18 (9.7%), 75 (40.3%), 61 (32.8%) and 32 (17.2%). The Wexner incontinence score was significantly reduced from 15 (±2.8) at baseline to 9.2 (±4.8) at the latest follow-up after a mean 878 ± 561 days (SD; P < 0.001). No correlation was found between the number of AEP and the functional outcome (P > 0.05). Patients with four-AEP had a reduced therapeutic amplitude up to 289 (±146) days of follow-up (P < 0.03). The number of AEP did not influence the need for extra follow-up visits (P < 0.223). CONCLUSION: The functional outcome and number of extra visits after SNS for FI did not depend on the number of AEP achieved. The therapeutic amplitude was reduced during the first postoperative year if four AEP were achieved during lead placement.
Sujet(s)
Électrothérapie/méthodes , Incontinence anale/thérapie , Neurostimulateurs implantables , Implantation de prothèse/méthodes , Sujet âgé , Soins ambulatoires/statistiques et données numériques , Bases de données factuelles , Incontinence anale/physiopathologie , Femelle , Études de suivi , Humains , Mâle , Adulte d'âge moyen , Études prospectives , Sacrum/innervation , Sacrum/chirurgie , Indice de gravité de la maladie , Nerfs spinaux/chirurgie , Résultat thérapeutiqueRÉSUMÉ
BACKGROUND: A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. METHODS: Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up. RESULTS: Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. CONCLUSION: Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up.
Sujet(s)
Canal anal/chirurgie , Défécation/physiologie , Incontinence anale/chirurgie , Prothèses et implants , Implantation de prothèse/méthodes , Qualité de vie , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Canal anal/physiopathologie , Études de faisabilité , Incontinence anale/physiopathologie , Femelle , Études de suivi , Humains , Mâle , Adulte d'âge moyen , Études prospectives , Conception de prothèse , Résultat thérapeutiqueRÉSUMÉ
AIM: Early results from sacral nerve stimulation (SNS) for severe irritable bowel syndrome (IBS) are promising but estimates of cost-effectiveness are lacking. Our object was to perform a cost-effectiveness analysis for SNS as an alternative to no treatment of IBS. METHOD: This retrospective analysis was based on the results from a randomized controlled crossover study with a cost-utility analysis performed on patient-level data and modelling of censored data over a projected period of time of up to 20 years. The analysis was conducted on an intention-to-treat approach. For estimation of the uncertainty of the incremental cost-effectiveness ratio a bias corrected bootstrap analysis was performed. RESULTS: Cost-effectiveness was not reached for 4 years after permanent implantation (£31 270 per quality-adjusted life years), which was the upper limit for patient follow-up, but our data imply a cost-effectiveness from a 7-year perspective onwards. CONCLUSION: The study indicates the SNS treatment for IBS is cost effective from a 7-year perspective onwards.
Sujet(s)
Analyse coût-bénéfice , Électrothérapie/économie , Syndrome du côlon irritable/thérapie , Plexus lombosacral , Études croisées , Danemark , Humains , Syndrome du côlon irritable/économie , Années de vie ajustées sur la qualité , Essais contrôlés randomisés comme sujet , Études rétrospectives , Indice de gravité de la maladieRÉSUMÉ
AIM: This randomized single-blinded crossover study aimed to investigate whether bilateral sacral nerve stimulation (SNS) is more efficient than unilateral stimulation for faecal incontinence (FI). METHOD: Patients with FI who responded during a unilateral test stimulation, with a minimum improvement of 50% were eligible. Twenty-seven patients who were accepted to enter the trial were bilaterally implanted with two permanent leads and pacemakers. Patients were randomized into three periods of 4 weeks' stimulation including unilateral right, unilateral left and bilateral stimulation. Symptoms scores and bowel habit diaries were collected at baseline and in each study period. A 1-week washout was introduced between each study period. RESULTS: Twenty-seven (25 female) patients with a median age of 63 (36-84) years were bilaterally implanted from May 2009 to June 2012. The median number of episodes of FI per 3 weeks significantly decreased from 17 (3-54) at baseline to 2 (0-20) during stimulation on the right side, 2 (0-42) during stimulation on the left side and 1 (0-25) during bilateral stimulation. The Wexner incontinence score improved significantly from a median of 16 (10-20) at baseline to 9 (0-14) with right-side stimulation, 10 (0-15) with left-side stimulation and 9 (0-14) with bilateral stimulation. The differences between unilateral right or unilateral left and bilateral stimulation were non-significant, for FI episodes (P = 0.3) or for Wexner incontinence score (P = 0.9). CONCLUSION: Bilateral SNS therapy for FI is not superior to standard unilateral stimulation in the short term. Equal functional results can be obtained regardless of the side of implantation.
Sujet(s)
Électrothérapie/méthodes , Incontinence anale/thérapie , Plexus lombosacral , Adulte , Sujet âgé , Sujet âgé de 80 ans ou plus , Études croisées , Électrodes implantées , Incontinence anale/physiopathologie , Femelle , Humains , Mâle , Adulte d'âge moyen , Indice de gravité de la maladie , Méthode en simple aveugle , Résultat thérapeutiqueRÉSUMÉ
AIM: The objective of primary radiotherapy for anal cancer is to remove cancer while maintaining anorectal function. However, little is known about anorectal function among long-term survivors without colostomy. Using a cross-sectional questionnaire study, we examined symptoms and distress related to the dysfunction of pelvic organs after radiotherapy for anal cancer. METHOD: A questionnaire regarding anorectal, urinary and sexual symptoms was sent to anal cancer patients without recurrence or colostomy, diagnosed during 1996-2003, and treated with curative intent (chemo)radiotherapy at three Danish centres. For each symptom we assessed frequency and severity and the level of symptom-induced distress (no, little, moderate or great distress). RESULTS: Of 94 eligible patients, 84 (89%) returned the completed questionnaire at a median of 33 months after radiotherapy. Incontinence for solid stools, liquid stools and gas occurred at least monthly in 31%, 54% and 79% of patients, respectively. Overall 40% of patients reported great distress from incontinence for solid or liquid stools at least monthly. Faecal urgency occurring at least monthly was experienced by 87% of patients and caused great distress in 43%. Stress, urge or another type of urinary incontinence occurred at least monthly in 45% and caused great distress in 21%. Urinary urgency occurred at least monthly in 48% but only caused great distress in 14%. Sexual desire was severely decreased in 58% and only 24% were satisfied with their sexual function. CONCLUSION: Distressing long-term anorectal and sexual dysfunction was common after radiotherapy for anal cancer, and morbidity due to urinary dysfunction was moderate.