Evaluation of the efficacy of sacral neuromodulation in the treatment of voiding dysfunction after endometriosis surgery.

Pelvic surgery for endometriosis is associated with a risk of bladder and digestive sequelae. Sacral neuromodulation (SNM) has been shown to be effective in the treatment of overactive bladder (OAB) and voiding dysfunction (VD). This study aimed to evaluate the efficacy of sacral neuromodulation (SNM) in treating voiding dysfunction (VD) following endometriosis surgery. A retrospective analysis was conducted on data from women who underwent SNM testing for persistent VD after endometriosis surgery. The study included 21 patients from a French tertiary referral center. Patient characteristics, lower urinary tract symptoms, urodynamic findings, SNM procedures, and outcomes were assessed. The primary outcome was the success of SNM treatment for VD. After a median follow-up of 55 months, 60% of patients achieved successful outcomes, with significant improvements of VD and quality of life. Moreover, more than half of patients who required clean intermittent self-catheterization (CISC) before SNM were able to wean off CISC. Complications such as infections and paraesthesia were observed, but overall, SNM was found to be effective and well tolerated. Age and the interval between endometriosis surgery and SNM testing were associated with treatment success. This study adds to the limited existing literature on SNM for VD after endometriosis surgery and suggests that SNM can be a valuable therapeutic option for these patients. Further research is needed to identify predictive factors and mechanisms underlying the effectiveness of SNM in this context. MRI-compatible and rechargeable devices, has improved the feasibility of SNM for these patients. In conclusion, SNM offers promise as a treatment option for persistent VD after endometriosis surgery, warranting further investigation. LEVEL OF EVIDENCE: 4.

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.

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.

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.

Recommendations on the management of pudendal nerve entrapment syndrome: A formalised expert consensus.

BACKGROUND: Since the development and publication of diagnostic criteria for pudendal nerve entrapment (PNE) syndrome in 2008, no comprehensive work has been published on the clinical knowledge in the management of this condition. The aim of this work was to develop recommendations on the diagnosis and the management of PNE. METHODS: The methodology of this study was based on French High Authority for Health Method for the development of good practice and the literature review was based on the PRISMA method. The selected articles have all been evaluated according to the American Society of Interventional Pain Physicians assessment grid. RESULTS: The results of the literature review and expert consensus are incorporated into 10 sections to describe diagnosis and management of PNE: (1) diagnosis of PNE, (2) patients advice and precautions, (3) drugs treatments, (4) physiotherapy, (5) transcutaneous electrostimulations (TENS), (6) psychotherapy, (7) injections, (8) surgery, (9) pulsed radiofrequency, and (10) Neuromodulation. The following major points should be noted: (i) the relevance of 4+1 Nantes criteria for diagnosis; (ii) the preference for initial monotherapy with tri-tetracyclics or gabapentinoids; (iii) the lack of effect of opiates, (iv) the likely relevance (pending more controlled studies) of physiotherapy, TENS and cognitive behavioural therapy; (v) the incertitudes (lack of data) regarding corticoid injections, (vi) surgery is a long term effective treatment and (vii) radiofrequency needs a longer follow-up to be currently proposed in this indication. CONCLUSION: These recommendations should allow rational and homogeneous management of patients suffering from PNE. They should also allow to shorten the delays of management by directing the primary care. SIGNIFICANCE: Pudendal nerve entrapment (PNE) has only been known for about 20 years and its management is heterogeneous from one practitioner to another. This work offers a synthesis of the literature and international experts' opinions on the diagnosis and management of PNE.

Bladder-colon chronic cross-sensitization involves neuro-glial pathways in male mice.

BACKGROUND: Irritable bowel syndrome and bladder pain syndrome often overlap and are both characterized by visceral hypersensitivity. Since pelvic organs share common sensory pathways, it is likely that those syndromes involve a cross-sensitization of the bladder and the colon. The precise pathophysiology remains poorly understood. AIM: To develop a model of chronic bladder-colon cross-sensitization and to investigate the mech-anisms involved. METHODS: Chronic cross-organ visceral sensitization was obtained in C57BL/6 mice using ultrasound-guided intravesical injections of acetic acid under brief isoflurane anesthesia. Colorectal sensitivity was assessed in conscious mice by measuring intracolonic pressure during isobaric colorectal distensions. Myeloperoxidase, used as a marker of colorectal inflammation, was measured in the colon, and colorectal permeability was measured using chambers. c-Fos protein expression, used as a marker of neuronal activation, was assessed in the spinal cord (L6-S1 level) using immunohistochemistry. Green fluorescent protein on the fractalkine receptor-positive mice were used to identify and count microglia cells in the L6-S1 dorsal horn of the spinal cord. The expression of NK1 receptors and MAPK-p38 were quantified in the spinal cord using western blot. RESULTS: Visceral hypersensitivity to colorectal distension was observed after the intravesical injection of acetic acid vs saline (P < 0.0001). This effect started 1 h post-injection and lasted up to 7 d post-injection. No increased permeability or inflammation was shown in the bladder or colon 7 d post-injection. Visceral hypersensitivity was associated with the increased expression of c-Fos protein in the spinal cord (P < 0.0001). In green fluorescent protein on the fractalkine receptor-positive mice, intravesical acetic acid injection resulted in an increased number of microglia cells in the L6-S1 dorsal horn of the spinal cord (P < 0.0001). NK1 receptor and MAPK-p38 levels were increased in the spinal cord up to 7 d after injection (P = 0.007 and 0.023 respectively). Colorectal sensitization was prevented by intrathecal or intracerebroventricular injections of minocycline, a microglia inhibitor, by intracerebroventricular injection of CP-99994 dihydrochloride, a NK1 antagonist, and by intracerebroventricular injection of SB203580, a MAPK-p38 inhibitor. CONCLUSION: We describe a new model of cross-organ visceral sensitization between the bladder and the colon in mice. Intravesical injections of acetic acid induced a long-lasting colorectal hypersensitivity to distension, mediated by neuroglial interactions, MAPK-p38 phosphorylation and the NK1 receptor.

Is it necessary to perform a morphological assessment for an esophageal motility disorder? A retrospective descriptive study.

BACKGROUND: Esophageal motility disorders are most often of primary origin but may be secondary to an occult malignancy or another etiology. High-resolution esophageal manometry cannot differentiate between secondary or primary origin. This study aimed at discussing the usefulness of a morphological assessment in the diagnosis of specific esophageal motility disorders, and to establish the predictive factors of a potential secondary origin. METHODS: In this retrospective study, patients with suspected esophageal motility disorders who underwent an esophageal manometry were included. High-resolution manometry results were interpreted according to the Chicago Classification, 3rd version. The results of endoscopic ultrasound and computed tomography, assessed by a panel of experts, allowed to diagnose a secondary origin. KEY RESULTS: Out of 2138 patients undergoing manometry, 502 patients had a esophageal motility disorder suspect to be from secondary origin; among them 182 patients underwent tomography or endoscopic ultrasound. According to experts, 16 patients (8.8%) had a secondary esophageal motility disorder: esophagogastric junction outflow obstruction (n = 7), jackhammer disorder (n = 4), achalasia (n = 3) and localized pressurization (n = 2). The etiology was malignant in 8 patients. Predictive factors suggesting potential secondary esophageal motility disorders were smoking, age ≥ 58 years and an Integrated Relaxation Pressure higher than 10 mmHg for water swallows. CONCLUSION AND INFERENCES: Esophageal motility disorders with organic origin are not uncommon. A morphological assessment using endoscopic ultrasonography and/or computed tomography may be of use to diagnose a secondary origin, especially in the elderly and smokers.

Assessment of pyloric sphincter distensibility and pressure in patients with diabetic gastroparesis.

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.

Efficacy and safety of sacral nerve modulation for faecal incontinence after pelvic radiotherapy.

OBJECTIVE: To assess the efficacy and safety of sacral nerve modulation (SNM) in patients with faecal incontinence (FI) after pelvic radiotherapy in comparison with results of SNM for FI related to other conditions. METHODS: Prospectively collected data from patients who underwent SNM therapy between January 2010 and December 2015 at 7 tertiary colorectal units were reviewed retrospectively. Patients with FI following pelvic radiotherapy were identified and matched (1:2) for age and sex with 38 patients implanted over the same period for FI without previous radiotherapy. The treatment was considered favourable if the patient reported any therapeutic benefit from SNM, had no further complaints or interventions and did not consider stopping the treatment. Long-term results, surgical revision and definitive explantation rates were compared. RESULTS: Among 352 patients who received a permanent SNM implant, 19 (5.4%) had FI following pelvic radiotherapy. After a mean follow-up of 3.5 ± 1.9 years, the cumulative successful treatment rates were similar between the groups (p = 0.60). For patients with FI following pelvic radiotherapy, the cumulative success rates were 99.4% [85.4-99.8], 96.7% [78.1-99.6], 91.7% [70.4-98.1] and 74.6% [48.4-94.8] at 1, 2, 3 and 5 years respectively. The revision and definitive explantation rates for infection did not differ significantly. CONCLUSION: The long-term success rate of SNM for FI after pelvic radiotherapy is similar to that of SNM for FI related to other more frequent conditions. Our study suggests that FI after pelvic radiotherapy could be improved with SNM without an increased risk of complication.

Pyloric distensibility measurement after gastric surgery: Which surgeries are associated with pylorospasm?

BACKGROUND AND STUDY AIMS: History of gastric surgery is found in 10% of patients with gastroparesis, and vagal lesion is often suspected to be the cause of pylorospasm. Recently, pyloric distensibility measurement using the EndoFLIP® system showed that pylorospasm was present in 30%-50% of gastroparetic patients. Our objective was to assess whether pylorospasm, diagnosed using EndoFLIP® system was observed in three different types of gastric surgeries: antireflux surgery, sleeve gastrectomy, and esophagectomy. PATIENTS AND METHODS: Pyloric distensibility and pressure were measured using the EndoFLIP® system in 43 patients from two centers (18 antireflux surgery, 16 sleeve gastrectomy, and nine esophagectomy) with dyspeptic symptoms after gastric surgery, and in 21 healthy volunteers. Altered pyloric distensibility was defined as distensibility below 10 mm2 /mm Hg as previously reported. RESULTS: Compared to healthy volunteers (distensibility: 25.2 ± 2.4 mm2 /mm Hg; pressure: 9.7 ± 4.4 mm Hg), pyloric distensibility was decreased in 61.1% of patients in the antireflux surgery group (14.5 ± 3.4 mm2 /mm Hg; P < .01) and 75.0% of patients in the esophagectomy group (10.8 ± 2.1 mm2 /mm Hg; P < .05), while pyloric pressure was only increased in the antireflux surgery group (18.9 ± 2.2 mm Hg; P < .01). Pyloric distensibility and pressure were similar in healthy volunteers and in sleeve gastrectomy (distensibility: 20.3 ± 3.8 mm2 /mm Hg; pressure: 15.8 ± 1.6 mm Hg) groups, with decreased pyloric distensibility affecting 18.7% of sleeve gastrectomy patients. CONCLUSION: Antireflux surgery and esophagectomy were associated with pylorospasm although pylorospasm was not found in all patients. Sleeve gastrectomy was not associated with altered pyloric distensibility nor altered pyloric pressure.

Assessment of anal sphincter distensibility following the STARR procedure: a pilot study.

Aim: The STARR (Stapled Trans-Anal Rectal Resection) procedure consists of a surgical correction of symptomatic rectocele refractory to medical treatment, involving anal dilatation. The aim of the study was to determine the impact of the STARR procedure on anal distensibility using EndoFLIP® device.Methods: All female patients with a minimal rectocele of 3 cm and with symptoms of obstructed defecation syndrome (ODS) refractory to medical treatment were included prospectively. Patients with previous anal incontinence were not included. Wexner, ODS and Kess scores were recorded. Endoanal ultrasounds and EndoFLIP® measurements were performed pre-surgery and 3 months following the STARR procedure. The distensibility index (DI) at 40 mL of inflation at rest was the primary study endpoint.Results: Seven patients (median age: 52.5, range: 44-62) were included between 2014 and 2017. The DI after surgery was the same as the pre-surgery DI. No patient developed symptoms of faecal incontinence or urge to defecate in the three months following the STARR procedure. All patients reported an improvement in their ODS and Kess scores three months after the STARR procedure. No anal sphincter defects were detected by endoanal ultrasound.Conclusion: Anal dilatation did not appear to alter anal distensibility in patients with a normal anal function before the STARR procedure.

Autologous Myoblasts for the Treatment of Fecal Incontinence: Results of a Phase 2 Randomized Placebo-controlled Study (MIAS).

OBJECTIVE: The aim of this study was to evaluate the efficacy of intrasphincteric injections of autologous myoblasts (AMs) in fecal incontinence (FI) in a controlled study. SUMMARY OF BACKGROUND DATA: Adult stem cell therapy is expected to definitively cure FI by regenerating damaged sphincter. Preclinical data and results of open-label trials suggest that myoblast therapy may represent a noninvasive treatment option. METHODS: We conducted a phase 2 randomized, double-blind, placebo-controlled study of intrasphincteric injections of AM in 24 patients. The study compared outcome after AM (n = 12) or placebo (n = 12) injection using Cleveland Clinic Incontinence (CCI), score at 6 and 12 months. Patients in the placebo group were eligible to receive frozen AM after 1 year. RESULTS: At 6 months, the median CCI score significantly decreased from baseline in both the AM (9 vs 15, P = 0.02) and placebo (10 vs 15, P = 0.01) groups. Hence, no significant difference was found between the 2 groups (primary endpoint) at 6 months. At 12 months, the median CCI score continued to ameliorate in the AM group (6.5 vs 15, P = 0.006), while effect was lost in the placebo group (14 vs 15, P = 0.35). Consequently, there was a higher response rate at 12 months in the treated than the placebo arm (58% vs 8%, P = 0.03). After delayed frozen AM injection in the placebo group, the response rate was 60% (6/10) at 12 months. CONCLUSIONS: Intrasphincteric AM injections in FI patients have shown tolerance, safety, and clinical benefit at 12 months despite a transient placebo effect at 6 months.

Reinnervation of the diaphragm by the inferior laryngeal nerve to the phrenic nerve in ventilator-dependent tetraplegic patients with C3-5 damage.

The aim of this study was to evaluate the feasibility of unilateral diaphragmatic reinnervation in humans by the inferior laryngeal nerve. This pilot study included chronically ventilated tetraplegic patients with destruction of phrenic nerve motoneurons. Five patients were included. They all had a high level of tetraplegia, with phrenic nerve motor neuron destruction. They were highly dependent on ventilation, without any possibility of weaning. They did not have other chronic pathologies, especially laryngeal disease. They all had diaphragmatic explorations to diagnose the destruction of the motoneurons of the phrenic nerves and nasoendoscopy to be sure that they did not have laryngeal or pharyngeal disease. Then, surgical anastomosis of the right phrenic nerve was performed with the inferior laryngeal nerve, by a cervical approach. A laryngeal reinnervation was performed at the same time, using the ansa hypoglossi. One patient was excluded because of a functional phrenic nerve and one patient died 6 months after the surgery of a cardiac arrest. The remaining three patients were evaluated after the anastomosis every 6 months. They did not present any swallowing or vocal alterations. In these three patients, the diaphragmatic explorations showed that there was a recovery of the diaphragmatic electromyogram of the right and left hemidiaphragms after 1 year. Two patients had surgical diaphragmatic explorations for diaphragmatic pacing 18-24 months after the reinnervation with excellent results. At 36 months, none of the patients could restore their automatic ventilation. In conclusion, this study demonstrated that diaphragmatic reinnervation by the inferior laryngeal nerve is effective, without any vocal or swallowing complications.

Does calprotectin level identify a subgroup among patients suffering from irritable bowel syndrome? Results of a prospective study.

BACKGROUND: Irritable bowel syndrome is a multifactorial disease. Although faecal calprotectin has been shown to be a reliable marker of intestinal inflammation, its role in irritable bowel syndrome remains debated. OBJECTIVE: The aims of this prospective study were to select a subgroup of irritable bowel syndrome patients and to characterise those patients with high faecal calprotectin by systematic work-up. METHODS: Calprotectin levels were determined by enzyme-linked immunosorbent assay test in consecutive irritable bowel syndrome patients fulfilling Rome III criteria in whom normal colonoscopy and appropriate tests had excluded organic disease. Calprotectin levels were compared in irritable bowel syndrome patients, healthy controls and patients with active and quiescent Crohn's disease. When the calprotectin level was higher than 50 µg/g, the absence of ANCA/ASCA antibodies and a normal small bowel examination were required to confirm irritable bowel syndrome diagnosis. Additional explorations included assessment of irritable bowel syndrome severity, anxiety and depression, impact on quality of life, glucose and fructose breath tests, rectal distension test by barostat and quantitative and qualitative assessment of inflammation on colonic biopsies. RESULTS: Among the 93 irritable bowel syndrome patients (73% women; 66.7% with diarrhoea) recruited, 34 (36.6%) had reproducibly elevated calprotectin. Although they tended to be older than those with normal calprotectin (P = 0.06), there were no other differences between the two groups. When elevated, calprotectin was correlated with age (P = 0.03, r = 0.22). CONCLUSIONS: Elevated faecal calprotectin was observed in one third of patients in this series, without any significant association with a specific clinical phenotype (except age) or specific abnormalities.

Botulinum toxin: an endoscopic approach for treating fecal incontinence.

BACKGROUND AND STUDY AIMS: Fecal incontinence is a common, distressing condition with limited therapeutic options. Botulinum toxin A (BTX-A) injections have been proposed as a treatment for patients with fecal incontinence. This study aimed to determine the short-term clinical outcomes of BTX-A injections in patients with fecal incontinence of varying etiology. PATIENTS AND METHODS: Twenty-six patients with fecal incontinence were enrolled, 17 with their native rectum and 9 with a neo-reservoir following a proctectomy for rectal cancer. BTX-A was endoscopically injected into the rectum/reservoir. Scores for severity (CCS) and quality of life (FIQL) were recorded at baseline and at the 3-month follow-up visit. RESULTS: The CCS was significantly lower after 3 months (median 15, range 4 - 20 vs. 8, range 1 - 19; P = 0.001). The quality of life improved in three of the four FIQL domains. The improvement was maintained in 11 of 12 patients who received more than one injection because of recurrent symptoms. There was no significant predictive factor for the success of BTX-A injections. CONCLUSION: This preliminary study demonstrated that rectal/reservoir injections are an effective short-term treatment for fecal incontinence.

Are digestive symptoms in women presenting with pelvic endometriosis specific to lesion localizations? A preliminary prospective study.

STUDY QUESTION: What are the types and frequency of digestive symptoms in patients with different localizations of pelvic endometriosis and which specific symptoms are related to rectal stenosis? SUMMARY ANSWER: There is a high prevalence of digestive complaints in women presenting with superficial pelvic endometriosis and deep endometriosis sparing the rectum. WHAT IS KNOWN ALREADY: Women presenting with pelvic endometriosis frequently report gastrointestinal complaints of increased intensity during menstruation, which are not necessarily linked to the infiltration of the disease into the rectal wall. Even though intrarectal protrusion of the nodule can have an impact on bowel movement, only a minority of women with rectal nodules seemed to be concerned by significant narrowing of the rectum. STUDY DESIGN AND SIZE: This three-arm cohort prospective study included 116 women and was carried out over 22 consecutive months. PARTICIPANTS, SETTING AND METHODS: Prospective recording of data was performed for women treated for Stage 1 endometriosis involving the Douglas pouch (n = 21), deep endometriosis without digestive infiltration (n = 42) and deep endometriosis infiltrating the rectum (n = 53). Patient characteristics, pelvic pain and data from preoperative standardized questionnaires The Gastrointestinal Quality of Life Index (GIQLI), the Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) and the MOS 36-Item Short-Form Health Survey (SF-36) were compared according to endometriosis localization. MAIN RESULTS: The values of total KESS and total GIQLI score were comparable for the three groups, as were a majority of the digestive complaints. Women presenting with rectal endometriosis were more likely to report an increase in intensity and length of dysmenorrhoea, while deep dyspareunia appeared to be more severe in women with superficial endometriosis. Women presenting with rectal endometriosis were more likely to present cyclic defecation pain (67.9%), cyclic constipation (54.7%) and a significantly longer stool evacuation time, although these complaints were also frequent in the other two groups (38.1 and 33.3% in women with Stage 1 endometriosis and 42.9 and 26.2% in women with deep endometriosis without digestive involvement, respectively). No independent clinical factor was found to be related to infiltration of the rectum by deep endometriosis. Among women with rectal endometriosis, only 26.4% presented with rectal stenosis. These women were significantly more likely to report constipation, defecation pain, appetite disorders, longer evacuation time and increased stool consistency without laxatives. LIMITATIONS: Patients treated for pelvic endometriosis in a tertiary referral centre may not be representative of the general endometriosis population presenting with those lesions. Statistically significant differences were revealed between the three groups; however, the results were based on a small number of subjects, which carries an inherent risk of type II error particularly when comparing variables with closed values. WIDER IMPLICATIONS OF THE FINDINGS: In women presenting with pelvic endometriosis, it seems likely that various digestive symptoms are the consequence of cyclic inflammatory phenomena leading to irritation of the digestive tract, rather than to actual infiltration of the disease itself into the rectum, with the exception of a limited number of cases where the disease leads to rectal stenosis. STUDY FUNDING/COMPETING INTEREST: The North-West Inter Regional Female Cohort for Patients with Endometriosis (CIRENDO) is financed by the G4 Group (The University Hospitals of Rouen, Lille, Amiens and Caen). No financial support was specifically received for this study. The authors declare no conflict of interest.

Long term efficacy of gastric electrical stimulation in intractable nausea and vomiting.

BACKGROUND: Although the efficacy of gastric electrical stimulation has been reported in short-term studies, there is a lack of data on the long-term improvement of nausea and vomiting by gastric electrical stimulation in patients with delayed or normal gastric emptying. METHODS: Thirty-one patients were implanted at our centre for medically refractory severe and chronic nausea and/or vomiting. Patients were evaluated at baseline, 6 months then 5 years after implantation (mean follow-up 80±4 months) using a symptomatic and quality of life scores. KEY RESULTS: Amongst the 31 patients, 4 were lost to follow-up, 6 explanted due to lack of improvement, and 1 patient died. Out of the 20 patients evaluated over 5 years, the quality of life score showed 27% improvement (p<0.01), including nausea (62%; p<0.01), vomiting (111%; p=0.03), satiety (158%; p<0.01), bloating (67%; p<0.01) and epigastric pain (43%; p=0.03). Over 5 years, 15/20 patients reported a 50% improvement with a global satisfaction rated at 64±6%. Therefore, 15/27 patients (56%) were improved by gastric electrical stimulation over 5 years in intention to treat. Improvement of nausea 6 months after implantation was predictive of 5-year success of gastric electrical stimulation (p=0.04). Finally, patients with delayed gastric emptying or with normal gastric emptying rate before surgery were similarly improved over 5 years (60% versus 50% respectively). CONCLUSION: Gastric electrical stimulation is safe and effective in the long term in patients with medically refractory nausea and vomiting, with an efficacy over 50% beyond 5 years in intention to treat. Gastric emptying measured before implantation did not influence the response rate over 5 years.