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.

A novel bowel rehabilitation programme after total mesorectal excision for rectal cancer: the BOREAL pilot study.

AIM: Low anterior resection syndrome (LARS) following sphincter-preserving surgery for rectal cancer has a high prevalence, with an impact on long-term bowel dysfunction and quality of life. We designed the bowel rehabilitation programme (BOREAL) as a proactive strategy to assess and treat patients with LARS. The BOREAL programme consists of a stepwise approach of escalating treatments: medical management (steps 0-1), pelvic floor physiotherapy, biofeedback and transanal irrigation (step 2), sacral nerve neuromodulation (step 3), percutaneous endoscopic caecostomy and anterograde enema (step 4) and definitive colostomy (step 5). METHODS: A pilot study was undertaken to assess the feasibility of collecting LARS data routinely with the parallel implementation of the BOREAL programme. All patients who underwent total mesorectal excision for rectal cancer between February 2017 and March 2019 were included. LARS was assessed using the LARS score and the Wexner Faecal Incontinence score at 30 days and 3, 6, 9 and 12 months postoperatively. A good functional result was considered to be a combined LARS score <20 and/or a Wexner score <4. RESULTS: In all, 137 patients were included. Overall compliance with the BOREAL programme was 72.9%. Major LARS decreased from 48% at 30 days postoperatively to 12% at 12 months, with a concomitant improvement in overall good function from 33% to 77%, P < 0.001. The majority of patients (n = 106, 77%) required medical management of their LARS. CONCLUSION: The BOREAL programme demonstrates the acceptability, feasibility and effectiveness of implementing a responsive, stepwise programme for detecting and treating LARS.

AGA Clinical Practice Update on Functional Heartburn: Expert Review.

BEST PRACTICE ADVICE 1: A diagnosis of functional heartburn should be considered when retrosternal burning pain or discomfort persists despite maximal (double-dose) proton pump inhibitor (PPI) therapy taken appropriately before meals during a 3-month period. BEST PRACTICE ADVICE 2: A diagnosis of functional heartburn requires upper endoscopy with esophageal biopsies to rule out anatomic and mucosal abnormalities, esophageal high-resolution manometry to rule out major motor disorders, and pH monitoring off PPI therapy (or pH-impedance monitoring on therapy in patients with proven gastroesophageal reflux disease [GERD]), to document physiologic levels of esophageal acid exposure in the distal esophagus with absence of reflux-symptom association (ie, negative symptom index and symptom association probability). BEST PRACTICE ADVICE 3: Overlap of functional heartburn with proven GERD is diagnosed according to Rome IV criteria when heartburn persists despite maximal PPI therapy in patients with history of proven GERD (ie, positive pH study, erosive esophagitis, Barrett's esophagus, or esophageal ulcer), and pH impedance testing on PPI therapy demonstrates physiologic acid exposure without reflux-symptom association (ie, negative symptom index and symptom association probability). BEST PRACTICE ADVICE 4: PPIs have no therapeutic value in functional heartburn, the exception being proven GERD that overlaps with functional heartburn. BEST PRACTICE ADVICE 5: Neuromodulators, including tricyclic antidepressants, selective serotonin reuptake inhibitors, tegaserod, and histamine-2 receptor antagonists have benefit as either primary therapy in functional heartburn or as add-on therapy in functional heartburn that overlaps with proven GERD. BEST PRACTICE ADVICE 6: Based on available evidence, acupuncture and hypnotherapy may have benefit as monotherapy in functional heartburn, or as adjunctive therapy combined with other therapeutic modalities. BEST PRACTICE ADVICE 7: Based on available evidence, anti-reflux surgery and endoscopic GERD treatment modalities have no therapeutic benefit in functional heartburn and should not be recommended.

Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial.

BACKGROUND & AIMS: There have been conflicting results from trials of gastric electrical stimulation (GES) for treatment of refractory vomiting, associated or not with gastroparesis. We performed a large, multicenter, randomized, double-blind trial with crossover to study the efficacy of GES in patients with refractory vomiting, with or without gastroparesis. METHODS: For 4 months, we assessed symptoms in 172 patients (66% women; mean age ± standard deviation, 45 ± 12 years; 133 with gastroparesis) with chronic (>12 months) of refractory vomiting (idiopathic, associated with a type 1 or 2 diabetes, or postsurgical). A GES device was implanted and left unactivated until patients were randomly assigned, in a double-blind manner, to groups that received 4 months of stimulation parameters (14 Hz, 5 mA, pulses of 330 µs) or no stimulation (control); 149 patients then crossed over to the other group for 4 months. Patients were examined at the end of each 4-month period (at 5 and 9 months after implantation). Primary endpoints were vomiting score, ranging from 0 (daily vomiting) to 4 (no vomiting), and the quality of life, assessed by the Gastrointestinal Quality of Life Index scoring system. Secondary endpoints were changes in other digestive symptoms, nutritional status, gastric emptying, and control of diabetes. RESULTS: During both phases of the crossover study, vomiting scores were higher in the group with the device on (median score, 2) than the control group (median score, 1; P < .001), in diabetic and nondiabetic patients. Vomiting scores increased significantly when the device was ON in patients with delayed (P < .01) or normal gastric emptying (P = .05). Gastric emptying was not accelerated during the ON period compared with the OFF period. Having the GES turned on was not associated with increased quality of life. CONCLUSIONS: In a randomized crossover study, we found that GES reduced the frequency of refractory vomiting in patients with and without diabetes, although it did not accelerate gastric emptying or increase of quality of life. Clinicaltrials.gov, Number: NCT00903799.

Antegrade Enema After Total Mesorectal Excision for Rectal Cancer: The Last Chance to Avoid Definitive Colostomy for Refractory Low Anterior Resection Syndrome and Fecal Incontinence.

BACKGROUND: Total mesorectal excision and preoperative radiotherapy in mid and low rectal cancer allow us to achieve very good oncological results. However, major and refractory low anterior resection syndrome and fecal incontinence alter the quality of life of patients with a long expected life span. OBJECTIVE: We assessed the functional results of patients treated by antegrade enema for refractory low anterior resection syndrome and fecal incontinence after total mesorectal excision. DESIGN: This is a prospective monocentric study from 2012 to 2016. PATIENTS: Patients who underwent percutaneous endoscopic cecostomy for refractory low anterior resection syndrome and fecal incontinence after total mesorectal excision were prospectively analyzed. MAIN OUTCOME MEASURES: We assessed the morbidity of the procedure and compared low anterior resection syndrome score, Wexner score, and Gastrointestinal Quality of Life Index before and after the use of antegrade enema. RESULTS: Of 25 patients treated by antegrade enema over the study period, 6 (24%) had a low anterior resection, 18 (72%) had a coloanal anastomosis, and 1 (4%) had a perineal colostomy. Postoperatively, the rate of local abscess was 8%, all treated by antibiotics. Low anterior resection syndrome score (33 vs 4, p < 0.001), Wexner score (16 vs 4, p <0.001), and Gastrointestinal Quality of Life Index (73 vs 104, p < 0.001) were all significantly improved after antegrade enema. The 2 main symptoms reported by patients were sweating (28%) and local pain (36%). At the end of the follow-up, 16% (n = 4) catheters were removed, and the rate of definitive colostomy was 12% (n = 3). LIMITATIONS: The main limitations of this study are the monocentric features and the sample size. CONCLUSION: Antegrade enema for major and refractory low anterior resection syndrome and fecal incontinence after total mesorectal excision appears to be a promising treatment to avoid definitive colostomy. See Video Abstract at http://links.lww.com/DCR/A608.

Effect of rebamipide on the colonic barrier in interleukin-10-deficient mice.

Our aim was to study the effect of a mucosal protective agent, rebamipide, on the colonic barrier and the immune response in colitis-prone interleukin-10-deficient (IL-10-/-) C57BL/6 mice infected with Helicobacter hepaticus. After sacrifice, in all mice, control, or previously infected with H. hepaticus, or previously infected and treated with rebamipide enema, a histological examination of colonic samples was performed, intestinal permeability was studied in Ussing chamber, and mesenteric lymph node proliferation and cytokine secretion were measured. Mice treated with rebamipide presented a reinforcement of the distal colonic epithelial barrier, an increase of mesenteric lymph node cells proliferation, and of IFNgamma and IL-12 secretion. These results indicate that in IL-10-/- mice with mild colitis, rectally administered rebamipide reinforces the distal colonic barrier and has a slight Th1 immuno-stimulatory effect on mesenteric lymph node cells. These properties could be helpful in the management of some inflammatory bowel diseases.