Translation of the nine item avoidant/restrictive food intake disorder screen (NIAS) questionnaire in French (NIAS-Fr).

BACKGROUND: The Nine Item Avoidant/Restrictive Food Intake Disorder (ARFID) Screen (NIAS) questionnaire is originally available in English. Given the significant overlap of ARFID-like symptoms in gastrointestinal (GI) diseases, ARFID screening becomes crucial in these patient populations. Consequently, the translation of the NIAS questionnaire into French is necessary for its utilization in French-speaking countries. METHODS: Clinical experts in neuro-gastroenterology and dietetics from four medical centres in two French-speaking countries (France and Belgium) took part in a well-structured questionnaire translation procedure. This process involved six steps before final approval: translation from English to French, backward translation, comparison between the original and retranslated versions, testing the translated version on patients, making corrections based on patient feedback, and testing the corrected version on an additional sample of patients. KEY RESULTS: The NIAS questionnaire in French (NIAS-Fr) was tested on 18 outpatients across the involved centres. For the majority of native French-speaking patients, the translated questionnaire was well understood and clear. After incorporating two relevant modifications suggested by the patients, the translated questionnaire was approved through testing on an additional sample of patients. CONCLUSIONS AND INFERENCES: The involvement of two French-speaking countries was crucial for the harmonization and cultural adaptation of the questionnaire. As a result, the NIAS-Fr is now available for use in 54 French-speaking countries, serving approximately 321 million French speakers across five continents for screening ARFID, for both clinical and research purposes.

Physiological characterization of gastric emptying using high-resolution antropyloroduodenal manometry.

Delayed gastric emptying (GE) has been associated with antral and pyloric dysmotility. We aimed to characterize differences in the antral, duodenal, and pyloric motility profiles associated with delayed GE, using high-resolution antropyloroduodenal manometry (HR-ADM). Patients referred for HR-ADM for dyspeptic symptoms performed a concurrent GE breath test (NCT01519180 and NCT04918329). HR-ADM involved 36 sensors 1 cm apart, placed across the pylorus. Interdigestive and postprandial periods were identified. Antral, pyloric, and duodenal motor profiles were analyzed recording the frequency, amplitude, and propagative nature of contractions for each period. Plots of patients with normal and delayed GE were compared. Sixty patients underwent both HR-ADM and GE tests. Twenty-five and 35 patients had delayed and normal GE, respectively. Antral and duodenal motor profiles were not different between the two groups during the interdigestive period. During the postprandial period, a lower frequency of antral contractions was associated with delayed GE (2.22 vs. 1.39 contractions/min; P = 0.002), but no difference in mean contraction amplitude was observed. The pyloric region was identified in all the patients and pylorospasms, defined as 3 min of repeated isolated pyloric contractions, were more frequent in patients with delayed GE (32.0% vs. 5.7%; P = 0.02) during the postprandial period. No difference in duodenal contraction profiles was observed. Manometric profile alterations were observed in 72% of the patients with delayed GE, with 56% having a low frequency of antral contractions. Using HR-ADM, patients with delayed GE displayed different postprandial antropyloric motility as compared with patients with normal GE.NEW & NOTEWORTHY High-resolution antropyloroduodenal manometry (HR-ADM) allows precise characterization of antral, pyloric, and duodenal motility, although its association with gastric emptying (GE) has been poorly investigated. Concurrent HR-ADM with GE measurement showed a lower frequency of antral postprandial contractions and an increased frequency of postprandial pylorospasms in patients with delayed GE. HR-ADM could, therefore, be useful in the future to better select patients for treatments targeting the pylorus.

Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study.

BACKGROUND: Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study. METHODS: In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence. Patients were randomly assigned (1:1) by a central web form to receive intrarectal submucosal injections of either 200 units of BoNTA (Botox; Allergan, Irvine, CA, USA; BoNTA group) or an equivalent volume of saline (placebo group), stratified by Cleveland Clinic Severity scores (CCS score; ≥12 or <12). Patients, investigators, study site staff, and sponsor personnel were masked to treatment allocation up to the 6-month visit. The primary endpoint was the number of episodes of faecal incontinence and urgency per day assessed using 21-day patient bowel diaries 3 months after the treatment. The primary analysis was performed using a modified intention-to-treat (mITT) approach (ie, in all the randomised patients who had received a treatment) with adjustment for baseline faecal incontinence and urgency episodes. After the final data collection at 6 months after injections, patients were unmasked and offered the BoNTA treatment if they were in the placebo group (rescue therapy) without masking, with an additional 6 months of safety follow-up. This trial is registered with ClinicalTrials.gov, number NCT02414425. FINDINGS: Between Nov 25, 2015, and Nov 25, 2020, we randomly assigned 200 patients to receive either BoNTA (n=100) or placebo (n=100) injections. Due to withdrawals before the injections, 96 patients were included in the BoNTA group and 95 patients were included in the placebo group (mITT analysis). The mean number of faecal incontinence and urgency episodes per day in the BoNTA group decreased from 1·9 (SD 2·2) at baseline to 0·8 (1·8) at 3 months after the injections, and from 1·4 (1·1) to 1·0 (1·0) in the placebo group, with a baseline-adjusted mean group difference at 3 months estimated at -0·51 (95% CI -0·80 to -0·21, p=0·0008). No serious treatment-related adverse events were reported in the trial. The most frequently reported non-serious adverse event (treatment related or not) following the BoNTA or placebo injections was constipation (reported in 68 [40%] of 169 patients who received the BoNTA injections and 38 [40%] of 95 patients who received placebo injections). INTERPRETATION: BoNTA injections are an efficacious treatment for urge faecal incontinence. Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results. FUNDING: General Direction of Healthcare (French Ministry of Health).

Fecal Incontinence Subtype Assessment (FI-SA): Validation of a new tool to distinguish among subtypes of fecal incontinence.

PURPOSE: Three subtypes of fecal incontinence (FI) are described in the literature: urge, mixed and passive FI, but the relevance of this classification remains unknown. To our knowledge, no questionnaire has been validated in a general population of patients with FI to classify patients between the different subtypes of FI. The aim of the present study was to validate the Fecal Incontinence Subtype Assessment (FI-SA) questionnaire in a general population of patients with FI. METHODS: All consecutive patients referred to our unit for physiological investigations of anorectal function in case of FI were included. A feasibility study was done to assess the acceptability, understanding, and the reproducibility of the FI-SA questionnaire. Its performance to correctly classify patients between subtypes of FI was evaluated in both a feasibility study and in a validation study, using clinical interview as gold standard. RESULTS: The FI-SA questionnaire was found to be well accepted and easily understood by patients. Moreover, it was filled rapidly by patients, with a good reproducibility with an intra-class correlation coefficient of 0.97 and 0.87 for questions 1 and 2. Lastly, the accuracy of the FI-SA questionnaire to predict subtypes of FI was 93.3 % in the feasibility study (n = 30) and 81.1 % in the validation study (n = 100), in comparison with clinical interview as gold standard. CONCLUSION: The FI-SA questionnaire could be used in the future to help standardize the methodology used among studies to evaluate the classification of patients in different subtypes of FI and ultimately to guide therapeutics.

Gastric electrical stimulation is safe during pregnancy and delivery: Results from a French cohort.

BACKGROUND: Gastric electrical stimulation (GES) is an effective therapy in medically refractory chronic nausea and vomiting. GES is assumed to be a contraindication for pregnancy. We examined the safety of GES during pregnancy and its clinical impact on vomiting symptoms. METHODS: A retrospective study was performed in two tertiary centers including all female patients of childbearing age implanted with GES. Patients without pregnancy while on GES were asked about their desire and concerns about pregnancy. Patients who were pregnant while on GES therapy were interviewed about the course of the pregnancy and labor, as well as the health of the children. KEY RESULTS: Among 91 patients implanted at childbearing age, 54 patients without pregnancy answered the questionnaire. Nine patients (16.7%) reported a desire for pregnancy and five patients (7.4%) reported worries about the safety of GES during pregnancy. Sixteen pregnancies were reported in 10 patients. All pregnancies ended in a live birth with premature birth in 12 pregnancies (75.0%). No health concern was currently noted in these children. No severe GES-related complications occurred during pregnancy with only pain at the implantation site reported during 3 pregnancies (18.8%). The severity and frequency of nausea and vomiting significantly increased during the first trimester (p = 0.04 and p = 0.005, respectively) and decreased after the delivery, becoming lower than before the pregnancy (p = 0.044 and p = 0.011, respectively). CONCLUSION & INFERENCES: Patients are concerned regarding pregnancy while being treated with GES. No serious maternal or fetal complications related to GES were noted in our cohort.

Multiple sclerosis and bowel symptoms: Frequency and barriers to their management.

BACKGROUND: The frequency of bowel symptoms (BSs) is still a matter for debate in multiple sclerosis (MS) patients. However, BSs have been shown to cause significant distress. Our study aimed to (i) investigate the frequency of BSs, particularly those that are not managed, (ii) identify potential predictors for help-seeking care for patients with BSs, and (iii) evaluate the ability of the Neurogenic Bowel Dysfunction (NBD) score to screen for BSs. METHOD: Three hundred sixty-nine MS patients completed a cross-sectional demographic and clinical survey of MS and BSs and their management. RESULTS: BSs were reported by 47.7% of MS patients. Eighty-eight percent of MS patients had a very minor-minor Neurogenic Bowel Disorder (NBD) score and 12% had a moderate-severe NBD score. Forty-one percent of patients did not report their BS to a healthcare provider, mainly because they preferred not to talk about the problem. BS duration was the only significant predictor of help-seeking for BS management. Female sex, visual impairment, a digestive history, and longer MS duration were good predictors of BSs. Patients with BSs (86%) were correctly identified with an NBD score >2. CONCLUSION: BSs are under-detected in MS populations. This is partially related to non-declaration by patients. Targeting BSs using the NBD score is a good way to increase reporting.

Impact of anesthetics on pyloric characteristics measured using the EndoFLIP® system in patients with gastroparesis.

BACKGROUND: Pyloric distensibility has been reported as a predictive measure in gastroparesis. Measures can be obtained either during endoscopy under anesthesia or in unsedated patients. However, the impact of anesthetic drugs on the results of pyloric characteristics remains unknown. The objective of the present study was to determine the impact of anesthetics on pyloric characteristics measured using EndoFLIP® in patients with gastroparesis. METHODS: Consecutive patients with gastroparesis from three French tertiary centers were retrospectively analyzed. Patients with a previous history of pyloric intervention were not considered for analysis. Medical records were reviewed for the potential use of anesthetic drugs during EndoFLIP® measurement. KEY RESULTS: One hundred twenty-five patients were included in the present study [median age: 55.0 years (43.0-66.0)]. Thirty-four patients (27.2%) had pyloric assessment without general anesthesia and 91 patients (72.8%) with general anesthesia. Pyloric pressure at 40 mL of distension was higher in patients with general anesthesia in comparison with patients without general anesthesia [18.7 (13.0-25.6) mmHg vs. 15.4 (11.9-20.7) mmHg; p = 0.044)]. In multivariate analysis, suxamethonium chloride administration was associated with decreased pyloric distensibility (OR: 3.9; 95% CI: 1.3-11.4; p = 0.013) while ephedrine was rather associated with increased pyloric distensibility (OR: 0.3; 95% CI: 0.1-0.9; p = 0.036). CONCLUSIONS AND INFERENCES: This study is the first to have found an impact of general anesthesia on pyloric measurement using the EndoFLIP®. Therefore, further studies are needed to confirm these findings, if possible, prospective studies.

Involvement of acid sensing ion channel (ASIC)-3 in an acute urinary bladder-colon cross sensitization model in rodent.

Introduction: Irritable bowel syndrome and bladder pain syndrome are both characterized by pain in response to organ distension. Epidemiologic studies showed that these two syndromes are often overlapped. Such overlap may be due to sharing of common extrinsic innervations between the colorectum and the urinary bladder, where cross-sensitization of the urinary bladder and the colon would occur in response to mechanical distension of either organ. The aim of this project was to develop and characterize a rodent model of urinary bladder-colon sensitization and to assess the role of the acid sensing ion channel (ASIC)-3. Methods: Double retrograde labelling was performed to identify extrinsic primary afferent neurons innervating both the colon (Fluororuby) and urinary bladder (Fluorogold) in the L6-S1 dorsal root ganglia (DRG) in Sprague Dawley rats. The phenotype of the colon/urinary bladder co-innervating primary afferent neurons was assessed using immunohistochemistry directed against ASIC-3. Cross-organ sensitization was induced in Sprague Dawley rats by using an echography-guided intravesical administration of acetic acid (0.75%) under brief isoflurane anesthesia. Colonic sensitivity was assessed in conscious rats by measuring abdominal contraction during isobaric colorectal distension (CRD). Measurement of urinary bladder and colonic paracellular permeabilities and tissue myeloperoxidase assay were performed. The involvement of ASIC-3 was assessed by use of S1 intrathecal administration of the ASIC-3 blocker, APETx2 (2.2 µM). Results: Immunohistochemistry showed that 73.1% of extrinsic primary afferent neurons co-innervating the colon and the urinary bladder express ASIC-3. By contrast, extrinsic primary afferent neurons innervating the colon only or the urinary bladder only were positive for ASIC-3 in 39.3% and 42.6%, respectively. Echography-guided intravesical administration of acetic acid resulted in colonic hypersensitivity to colorectal distension. This effect started 1 h post-injection and lasted up to 24 h, and was not longer seen after 3 days after injection. No colonic hyperpermeability and no difference in urinary bladder and colon MPO activity was observed between control and acetic acid-treated rats. Colonic sensitization by intravesical acetic acid administration was prevented by S1 intrathecal administration of APETx2. Conclusion: We developed an acute pelvic cross-organ sensitization model in conscious rat. In this model, cross-organ sensitization is likely to involve S1-L6 extrinsic primary afferents co-innervating the colon and urinary bladder through an ASIC-3 pathway.

Gastric electrical stimulation versus per-oral pyloromyotomy for the treatment of nausea and vomiting associated with gastroparesis: An observational study of two cohorts.

BACKGROUND: Both gastric electrical stimulation (GES) and gastric-peroral endoscopic myotomy (G-POEM) can be offered to patients with gastroparesis and predominant nausea and vomiting. The study's aim was to compare GES and G-POEM efficacy on nausea and vomiting scores in patients with gastroparesis. METHODS: Two multicenter cohorts of patients with medically refractory gastroparesis with predominant nausea and vomiting (defined as a score >2 on nausea and vomiting subscale that varied from 0 to 4) were treated either with GES (n = 34) or G-POEM (n = 30) and were followed for 24 months (M). Clinical response was defined as a decrease of ≥1 point in nausea and vomiting subscale without premature exclusion due to switch from one to the other technique before M24. Changes in symptomatic scales and quality of life were also monitored. KEY RESULTS: Patients from both groups were comparable although the mean score of nausea and vomiting subscale was higher in GES (3.0) compared to G-POEM group (2.6; p = 0.01). At M24, clinical response was achieved in 21/34 (61.7%) patients with GES and in 21/30 (70.0%; p = 0.60) patients with G-POEM. Mean scores of nausea and vomiting subscale decreased at M24 in both GES (from 3.0 to 1.6; p < 0.001) and G-POEM (from 2.6 to 1.2; p < 0.001) groups, although there was no difference between groups (difference adjusted from baseline: -0.28 [-0.77; 0.19]; p = 0.24). Likewise, symptomatic and quality of life scores improved at M24 in both groups, without difference according to treatment group. CONCLUSIONS AND INFERENCES: At M24, we did not observe significant difference in efficacy of GES and G-POEM in medically refractory gastroparesis with predominant nausea and vomiting.

Targeting the pylorus in gastroparesis: From physiology to endoscopic pyloromyotomy.

BACKGROUND: The pylorus plays a key role in the control of gastric content outflow. Impairment of pyloric physiology has been observed in gastroparesis, particularly when associated with diabetes mellitus or opioid intake or after antireflux surgery. New tools have been developed to identify pyloric dysfunction in routine care, including functional luminal impedance planimetry (FLIP). As such, a new therapeutic strategy targeting the pylorus, namely endoscopic pyloromyotomy (G-POEM), has received increasing attention and emerged as a promising treatment for gastroparesis. PURPOSE: The present review details the involvement of the pyloric pathophysiology in gastroparesis, as well as clinical results of G-POEM according to the current literature.

Relationship between anal functional lumen imaging probe (EndoFLIP®) results and the clinical presentation of faecal incontinence.

AIM: Faecal incontinence (FI) subtypes (urge, passive, mixed) are linked to the physiopathological mechanism of FI. Previous studies have failed to demonstrate a consistent relationship between FI subtype and anal sphincter dysfunction. Our aim was to evaluate the relationship between anal sphincter function, assessed using the new EndoFLIP® technology, and FI subtype. METHOD: Patients referred for FI were prospectively enrolled between October 2015 and May 2021 in a registry, and data were retrospectively examined. Each patient underwent a clinical assessment as well as three-dimensional high-resolution or water-perfused anorectal manometry, anal EndoFLIP®, and anorectal electrophysiological and endoanal ultrasound tests. The results of the investigations were compared across FI subtypes. RESULTS: The cohort included 133 patients, 54 (41%) of whom met the criteria for urge FI, 40 (30%) for passive FI and 39 (29%) for mixed FI. The resting anal distensibility index (DI) at 50 ml of distension was significantly lower in patients with urge FI than in patients with passive FI (p = 0.04). At rest, a DI at 50 ml of distension ≥7.3 mm2  mmHg-1 and a DI at 40 ml of distension <1.3 mm2  mmHg-1 were associated with the passive and urge FI subtypes, respectively, with poor discriminatory power (an accuracy of 0.49 compared with 0.33 for random assignment). There were no differences in anorectal manometry, endoanal ultrasound or electrophysiological test results among the urge, passive and mixed FI subgroups (all p > 0.05). CONCLUSION: The anal sphincter DI using the EndoFLIP® system displayed poor predictive performance in distinguishing among FI subtypes.

Gastric Electrical Stimulation: Role and Clinical Impact on Chronic Nausea and Vomiting.

Gastric electrical stimulation (GES) is currently used as an alternative treatment for medically refractory gastroparesis. GES has been initially developed to accelerate gastric motility, in order to relieve the symptoms of the patients. Subsequent studies, unfortunately, failed to demonstrate the acceleration of gastric emptying using high-frequency stimulation - low energy stimulation although the technique has shown a clinical impact with a reduction of nausea and vomiting for patients with gastroparesis. The present review details the clinical efficacy of GES in gastroparesis as well as its putative mechanisms of action.

Overlaps with bladder pain syndrome and irritable bowel syndrome are associated with higher symptom burden and reduced quality of life in functional dyspepsia.

BACKGROUND: Functional dyspepsia and bladder pain syndrome are well-known to overlap with irritable bowel syndrome. Whether functional dyspepsia overlaps with bladder pain syndrome remains unknown. Our aim was to evaluate the presence of bladder pain syndrome in functional dyspepsia patients and its impact. METHODS: All consecutive patients with investigated dyspeptic symptoms in our tertiary care center between March 2015 and November 2018 were studied. Functional dyspepsia and irritable bowel syndrome were diagnosed according to Rome III and IV criteria while bladder pain syndrome was diagnosed using ESSIC criteria. Validated questionnaires were filled to assess quality of life (GIQLI), anxiety and depression (HADS), sleep (PSQI), and insomnia (ISI). Dyspeptic symptoms severity was assessed individually for eight dyspeptic complaints. KEY RESULTS: Among 1453 patients with dyspeptic symptoms, 61.4% fulfilled Rome criteria for functional dyspepsia. Bladder pain syndrome was present in 16.0% of the patients not fulfilling diagnostic criteria for functional dyspepsia, 22.2% of patients with functional dyspepsia alone, and 36.4% of patients with overlapping functional dyspepsia and irritable bowel syndrome (p-values <0.0001). In patients with bladder pain syndrome overlapping with functional dyspepsia, dyspeptic symptoms severity, anxiety, depression, and insomnia levels were higher while quality of life and sleep quality were reduced (p-values <0.0001). These results were even more pronounced in case of overlap with irritable bowel syndrome (p-values <0.0001). CONCLUSIONS AND INFERENCES: Bladder pain syndrome is present in 26.9% of functional dyspepsia patients and is associated with higher gastrointestinal, psychological distresses, and sleep symptom burdens, and with reduced quality of life.

Sleep Quality and Insomnia Are Associated With Quality of Life in Functional Dyspepsia.

BACKGROUND: Sleep disturbances are common in patients with functional dyspepsia. Our aim was to assess the relationship between subjective sleep and quality of life and to identify factors associated with impaired sleep in functional dyspepsia. METHODS: One thousand two hundred and twenty patients referred for functional gastrointestinal disorders at a single tertiary care center between end 2017 and June 2019 were studied using a self-administered questionnaire. 355 patients with Rome IV-based functional dyspepsia were identified. Sleep was assessed using both the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI). The severity of dyspeptic symptoms was assessed using the Total Symptom Score (TSS). Quality of life was assessed by the GastroIntestinal Quality of Life Index (GIQLI). Anxiety and depression levels were evaluated using the Hospital Anxiety and Depression (HAD) scale. KEY RESULTS: Among the 355 patients with functional dyspepsia, 66 (18.6%) patients displayed normal sleep quality whereas 289 (81.4%) patients had altered sleep quality. Functional dyspepsia patients with sleep disturbances were older (48.1 ± 15.4 vs. 41.4 ± 16.0, p = 0.0009), had decreased quality of life (GIQLI: 75.3 ± 18.5 vs. 92.1 ± 15.4, p < 0.0001), greater severity of their symptoms (TSS: 18.9 ± 3.6 vs. 17.2 ± 3.9, p = 0.0007), and higher anxiety and depression scores (HADS: 17.7 ± 7.2 vs. 11.9 ± 5.1, p < 0.0001). A correlation was found between sleep quality and quality of life [r = -0.43 (95% CI: -0.51 to -0.34), p < 0.0001]. Independent factors predicting poor sleep quality were age [OR 1.03 (95% CI = 1.01-1.05), p = 0.006], depression level [OR 1.27 (95% CI = 1.16-1.39); p < 0.0001], and the severity of dyspeptic symptoms [OR 1.13 (95% CI = 1.04-1.22); p = 0.004]. CONCLUSION AND INFERENCES: A high prevalence of sleep disturbances was found in patients suffering from functional dyspepsia, with 81% of them having altered sleep quality and 61% having insomnia based on subjective assessment. Altered sleep quality and insomnia were associated with altered quality of life, higher severity of symptoms, and higher anxiety and depression scores in this disorder.

Is sacral nerve modulation reprogramming effective after permanent implantation for faecal incontinence?

AIM: Sacral nerve modulation (SNM) is recommended as a first-line surgical therapy for patients with faecal incontinence (FI). During patient follow-up, it is recommended that stimulation settings be reprogrammed to optimize patient outcomes. The aim of the present study was to evaluate the efficacy of stimulator reprogramming in patients with an implanted SNM device to treat FI. METHOD: The data from patients who received a permanent SNM implant in a single centre from January 2008 to December 2019 were retrospectively analysed. Symptoms that occurred after implantation, the stimulator settings of the SNM device and changes made at each follow-up visit were noted. The efficacy of reprogramming was determined by assessing patient satisfaction. RESULTS: Of the 117 patients (male/female 4/113; mean age 59.5 ± 11.8 years) with a SNM implant for FI, 84 (72%) had at least one symptom requiring reprogramming of the stimulator, most often during the first year after implantation (p = 0.05). The most frequently reported symptoms were loss of efficacy (68.5%; p = 1 × 10-3 ) and pain (20.5%; p = 1 × 10-3 ). Reprogramming was effective 53% of the time when treating loss of efficacy and 76% of the time when treating pain. When the stimulation parameters were reprogrammed at least four consecutive times to correct a symptom, the reprogramming was less effective in treating the symptom (p = 0.02). CONCLUSION: Regular follow-up of patients with SNM device implants associated with reprogramming of stimulation parameters to improve the treatment of reported symptoms would optimize the efficacy of SNM.

Delayed gastric emptying as an independent predictor of mortality in gastroparesis.

BACKGROUND: Whether gastroparesis is associated with a shortened life expectancy remains uncertain as no systematic study has evaluated the impact of gastroparesis on mortality, based on gastric emptying (GE) tests. AIM: This study aimed to assess whether delayed GE was predictive of mortality. METHODS: GE was measured using a 13C-octanoic acid breath test in 1563 consecutive patients. Delayed GE at baseline defined the gastroparesis group. Patients were followed up for a mean of 8.9 years, yielding 13 466 patients per year. Mortality was assessed using the French CepiDc database with data from local civil registries. The cause of death was determined from medical records. Mortality rates were assessed using the Kaplan-Meier method and hazard ratio (HR) was calculated using the Cox regression model. RESULTS: Age and symptoms severity were not different among patients with normal GE (n = 1179) and with delayed GE (n = 384) while diabetes mellitus was more frequent in the gastroparesis group. Kaplan-Meier analysis showed increased mortality in the gastroparesis group compared to patients with normal GE. Cox regression model identified delayed GE as independently associated with increased mortality (HR = 1.63[1.09-2.42]; P = 0.02). Other independent factors associated with increased mortality included age, male sex, and diabetes. No difference was observed between groups for the cause of death, with cancer and cardiovascular disease being the leading causes. CONCLUSION: This study has shown that gastroparesis, diagnosed on GE tests, was associated with increased mortality, independently of age, sex, BMI or diabetes status (NCT04918329).

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

Impact of Gastric Electrical Stimulation on Economic Burden of Refractory Vomiting: A French Nationwide Multicentre Study.

BACKGROUND & AIMS: Medico-economic data of patients suffering from chronic nausea and vomiting are lacking. In these patients, gastric electrical stimulation (GES) is an effective, but costly treatment. The aim of this study was to assess the efficacy, safety and medico-economic impact of Enterra therapy in patients with chronic medically refractory nausea and vomiting. METHODS: Data were collected prospectively from patients with medically refractory nausea and/or vomiting, implanted with an Enterra device and followed for two years. Gastrointestinal quality of life index (GIQLI) score, vomiting frequency, nutritional status and safety were evaluated. Direct and indirect expenditure data were prospectively collected in diaries. RESULTS: Complete clinical data were available for142 patients (60 diabetic, 82 non-diabetic) and medico-economic data were available for 96 patients (36 diabetic, 60 non-diabetic), 24 months after implantation. GIQLI score increased by 12.1 ± 25.0 points (p < .001), with a more significant improvement in non-diabetic than in diabetic patients (+15.8 ± 25.0 points, p < .001 versus 7.3 ± 24.5 points, p = .027, respectively). The proportion of patients vomiting less than once per month increased by 25.5% (p < .001). Hospitalisations, time off work and transport were the main sources of costs. Enterra therapy decreased mean overall healthcare costs from 8873 US$ to 5525 US$ /patient/year (p = .001), representing a saving of 3348 US$ per patient and per year. Savings were greater for diabetic patients (4096 US$ /patient/year) than for non-diabetic patients (2900 US$ /patient/year). CONCLUSIONS: Enterra therapy is an effective, safe and cost-effective option for patients with refractory nausea and vomiting. CLINICALTRIALS: gov Identifier: NCT00903799.