Background
Gastric electrical simulation has been shown to relieve nausea and vomiting in medically refractory patients. Efficacy of gastric electrical stimulation has been reported mostly in ...short‐term studies, but none has evaluated its efficacy beyond 10 years after implantation.
Methods
Patients implanted at our center for medically refractory severe and chronic nausea and/or vomiting were evaluated before and over 10 years after implantation using symptomatic scale and quality of life (GIQLI) score. Improvement was defined as a reduction of more than 50% in vomiting frequency.
Key Results
A total of 50 patients were implanted from January 1998 to December 2009. Among them, 7 were explanted due to a lack of efficacy and/or side effects, 2 died, and 4 were lost to follow‐up. Mean follow‐up was 10.5 ± 3.7 years. In intention‐to‐treat analysis, 27/50 (54%) patients reported an improvement. Beyond 10 years, an improvement in early satiety (3.05 vs 1.76, <0.001), bloating (2.51 vs 1.70, P = .012), nausea (2.46 vs 1.35, P = .001), and vomiting (3.35 vs 1.49 P < .001) scores were observed. Quality of life improved over 10 years (GIQLI score: 69.7 vs. 86.4, P = .005) and body mass index (BMI: 23.4 vs. 26.2 kg/m2; P = .048).
Conclusions and Inferences
Gastric electrical simulation is effective in the long‐term in patients with medically refractory nausea and vomiting, with an efficacy of 54% at 10 years on an intention‐to‐treat analysis. Other long‐term observational studies are warranted to confirm these results.
Background
Recent studies have shown that pyloric distensibility is altered in 30–50% of gastroparetic patients but the number of diabetic patients included in prior reports has been small. The aim ...of the present study was to assess pyloric sphincter measurements in diabetic patients with gastroparesis and to determine whether diabetes characteristics were correlated to pyloric disfunction.
Methods
Pyloric distensibility and pressure were measured using EndoFLIP® system in 46 patients with diabetic gastroparesis (DGP) and compared with 21 healthy volunteers (HV), and 33 patients with idiopathic gastroparesis (IGP). Altered pyloric distensibility was defined as the measurement below 10 mm2/mmHg at 40 ml of inflation. In diabetic patients, blood glucose, glycated hemoglobin, duration, complications, and treatments were collected.
Key Results
Mean pyloric distensibility at 40 ml of inflation was lower in DGP and IGP groups with, respectively, 10.8 ± 0.9 mm2/mmHg and 14.8 ± 2.2 mm2/mmHg in comparison with the HV group (25.2 ± 2.3 mm2/mmHg; p < 0.005). 56.5% of patients had a decreased pyloric distensibility in the DGP group, 51.5% of patients in the IGP group, and 10% of patients in the HV group. No correlation was found between pyloric sphincter measurements and diabetes characteristics, including blood glucose, glycated hemoglobin, diabetes mellitus type, neuropathy, or GLP1 agonists intake.
Conclusion and Interferences
Pyloric sphincter distensibility and pressure were altered both in diabetic and idiopathic gastroparesis. Pyloric sphincter distensibility was not correlated to diabetes parameters.
Pyloric sphincter distensibility and pressure were altered both in diabetic and idiopathic gastroparesis. Pyloric sphincter distensibility was not correlated with diabetes parameters.
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.
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. We recommend to systematically assess the presence of bladder pain syndrome in patients with functional dyspepsia.
Aim
To compare transanal irrigation with conservative bowel management for the treatment of bowel dysfunction in Spina bifida (SB) patients.
Methods
Patients with SB and bowel dysfunction were ...randomly assigned to receive either transanal irrigation or conservative bowel management. The effectiveness of the treatment was defined as a decrease of 4 points in the neurogenic bowel dysfunction (NBD) score at week 10. Data on incontinence (Cleveland scores; Jorge‐Wexner JW) and constipation (Knowles‐Eccersley‐Scott Symptom Constipation Score KESS) were recorded at 10 and 24 weeks after inclusion. Data were analysed on an intention‐to‐treat basis.
Results
A total of 34 patients were randomised: 16 patients to conservative bowel management and 18 patients to transanal irrigation. A total of 19/31 (61%) patients improved at week 10, 13 (76%) in the transanal irrigation group versus six (43%) in the conservative group (p = 0.056). In the irrigation group, the decrease in NBD score was −6.9 (−9.9 to −4.02) versus −1.9 (−6.5 to −2.8) in the conservative group (p = 0.049 in univariate and p = 0.004 in multivariate analysis). The NBD, Cleveland (JW and KESS) and Rosenberg scores were significantly lower in the transanal irrigation group than in the conservative bowel management group at week 10.
Conclusions
This prospective, randomised, controlled, multicentre study in adult patients with SB suggests that transanal irrigation may be more effective than conservative bowel management.
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.
Recent studies have reported that pyloric distensibility was altered in 30% to 50% of patients with gastroparesis, and this was correlated with gastric emptying and symptom severity. The aim of this ...study was to assess whether pyloric distensibility measurement was predictive of symptomatic response after intrapyloric botulinum toxin (BT) injection.
Pyloric distensibility was measured using the EndoFLIP system (Crospon, Galway, Ireland) before intrapyloric BT injection. Altered pyloric distensibility was defined as distensibility below 10 mm2/mm Hg. Total symptomatic score (TSS), dyspeptic symptoms, Gastrointestinal Quality of Life Index (GIQLI), and gastric emptying were investigated prospectively before and 3 months after BT injection.
Nineteen of 35 patients had altered pyloric distensibility. In those patients, TSS decreased at 3 months from 13.5 to 10.5 (P < .01), whereas it remained unchanged in patients with normal pyloric distensibility (P = .7). Gastric fullness (from 3.5 to 2.5; P = .03) and bloating (from 3.0 to 2.0; P = .01) were the only symptoms that improved in patients with altered pyloric distensibility, whereas none of them was improved in patients with normal pyloric distensibility. GIQLI score increased from 59.5 to 76.5 in patients with altered pyloric distensibility (P = .02), whereas there was no statistical difference (P = .43) in patients with normal pyloric distensibility. In patients with altered pyloric distensibility, gastric emptying half time was 223 minutes before and 190 minutes 3 months after injection (P = .02), whereas it remained unchanged in patients with normal pyloric distensibility (P = .6).
Pyloric distensibility measurement before intrapyloric BT injection predicted symptomatic and quality of life response 3 months after injection in patients with gastroparesis.
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Background and purpose
The EndoFLIP® system is a method of delineating impedance and was first designed to investigate the characteristics of the esophago‐gastric junction. In the last decade, its ...use was widened to investigate other sphincteric and non‐sphincteric systems of the gastrointestinal tract. The objective of the present systematic review was to summarize the available data in literature on the use of the EndoFLIP® system in the gastrointestinal tract, including sphincteric and non‐sphincteric regions. We performed a systematic review in accordance with recommendations for systematic review using PRISMA guidelines without date restriction, until June 2020, using MEDLINE‐PubMed, Cochrane Library, and Google Scholar databases. Only articles written in English were included in the present review. Five hundred and six unique citations were identified from all database combined. Of those, 95 met the inclusion criteria. There was a lack of standardization among studies in terms of anesthetic drugs use, probe placement, and inflation protocol. In most cases, only small cohorts of patients were included. Most studies investigated the EGJ, with a potential use of the EndoFLIP® to identify a subgroup of patients with achalasia and for intraoperative assessment of treatment efficacy in achalasia. However, the use of EndoFLIP® in the esophageal body (esophageal panometry), other esophageal diseases (gastro‐esophageal reflux disease, eosinophilic esophagitis), and other sphincter regions (anal canal, pylorus) will need further confirmatory studies. The EndoFLIP® system provides detailed geometric data of the gastrointestinal lumen but further works are needed to determine its use in clinical practice.
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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;
= 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%;
= 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.
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.
Aim
The aim of this work was to evaluate the effectiveness, patient satisfaction and quality of life (QoL) and the safety of sacral neuromodulation (SNM) with the InterStimTM system for the treatment ...of faecal incontinence (FI) and establish whether results published predominantly by expert sites are generalisable.
Method
This is a prospective, multicentre, observational study that invited all French sites treating FI with the InterStim™ system to enrol subjects indicated for an SNM therapy evaluation. Data were collected at three follow‐up visits within 1 and 15 months. Therapeutic effectiveness was evaluated by the reduction in leakages per week and improvements over time in the ability to defer defaecation and QoL (as measured with the Faecal Incontinence Quality of Life score). Safety was assessed through reported adverse events.
Results
A total of 221 subjects with a mean age of 62.1 years were tested (184 women) and 178 received a permanent implant. For all implanted subjects with diary data at baseline and follow‐up, a reduction in leakage of more than 50% was observed in 80%, 76% and 83% at 1–3, 4–8 and 9–15 months, respectively. The mean number of leakage episodes and urgency improved significantly compared with the baseline (p < 0.0001). Subjects showed improvements in QoL and time to defer defaecation and were generally satisfied with their therapy. The main device‐related adverse event was the requirement to undertake reprogramming (in 52% of subjects with actions following an event). The rates of infection (in 6% of subjects) and surgical revision (in 10% of subjects) were in agreement with literature reports.
Conclusion
This study confirms the clinical effectiveness, safety and positive effect of SNM on QoL as well as high patient satisfaction for the treatment of FI in real‐life.