Timing of High-Dose-Rate Brachytherapy With External Beam Radiation Therapy in Patients With Intermediate- and High-Risk Localized Prostate Cancer and Its Effects on Toxicity and Quality of Life: A Randomized Controlled Trial (THEPCA).

PURPOSE: High-dose-rate brachytherapy (HDR-BT) and external beam radiation therapy (EBRT) are effective treatments for prostate cancer but cause genitourinary (GU) and gastrointestinal (GI) toxicities. There is no consensus on the timing of HDR-BT in relation to EBRT and the effect of sequencing on patients. The primary objective was to assess differences, if any, in the incidence of grade (G) 3 or higher GU toxicities from treatment. We also aimed to explore the incidence of G1 to G4 GI toxicities, quality of life (QOL), and patient satisfaction. Suppression of prostate-specific antigen (PSA) and signals for survival differences were also analyzed. METHODS AND MATERIALS: This was a single-center randomized trial in patients with intermediate- and high-risk localized prostate cancer who received HDR-BT before (Arm A) or after (Arm B) EBRT. Toxicities were graded using Common Terminology Criteria for Adverse Events (CTCAE). The International Prostate Symptom Score (IPSS) was used to assess lower urinary tract symptoms. The International Index of Erectile Function scale (IIEF) and Functional Assessment of Cancer Therapy-Prostate (FACT-P) were used to assess erectile dysfunction and QOL at 0, 3, 9, and 12 months. RESULTS: Fifty patients were recruited to each arm, with 48 and 46 patients completing treatment and follow-up in each arm, 81.5% of whom had high-risk disease. There were no G3 or G4 GU or GI toxicities. G1 urinary frequency was the most common adverse event experienced in both arms, peaking in incidence 3 months after treatment commenced (45.7% and 42.2% in Arm A and B, respectively). Up to 11% of patients reported G1 urinary frequency at 12 months. Other G1 GU toxicities experienced by >10% of patients were urinary tract obstruction, tract pain, and urgency. These symptoms also peaked in incidence at 3 months. G2 GU toxicities were uncommon and experienced in a maximum of 2 patients within each arm at any time point. Over 30% of patients had G1 flatulence at baseline, and this remained the most frequently occurring G1 GI toxicity throughout the study, peaking at 12 months (21.4% and 25.6% in Arm A and B, respectively). Other GI toxicities experienced by more than 10% of patients were GI pain, proctitis, and rectal mucositis, most of which demonstrated a peak incidence at 3 or 9 months. G2 GI toxicities were uncommon except for G2 flatulence. No significant difference was found in CTCAE, IPSS, IIEF, FACT-P, and QOL scores between the arms. Median prostate-specific antigen (PSA) follow-up was 5 years. Seven patients had treatment failure in each arm. Disease Free Survival (DFS) was 93.3% and 90.7% at 5 years in Arm A and B, respectively, with median failure time of 60 and 48 months in Arm A and B, respectively. There were no statistically significant differences between arms. CONCLUSIONS: The sequencing of HDR-BT and EBRT did not affect the incidence of G3 or G4 toxicities, and no significant differences were seen in other patient-reported outcomes. Treatment was well tolerated with maintained QOL scores. Treatment failure was low in both arms in a high-risk cohort; however, a larger study with longer follow-up is underway to establish whether the difference in median time to failure between the 2 arms is a signal of superiority.

Effects of a Mobilization Program Applied to Bariatric Surgery Patients on Preventing Gastrointestinal Complications: a Quasi-Experimental Study.

PURPOSE: To investigate the effects of a planned early targeted mobilization program applied to patients that underwent bariatric surgery with the laparoscopic sleeve gastrectomy method on gastrointestinal complications (nausea-vomiting, abdominal distention, delayed flatus-defecation, and intolerance of early oral intake). MATERIALS AND METHODS: This prospective, controlled group, quasi-experimental design study was conducted between July 2019 and March 2020 in the general surgery clinic of a training and research hospital with 70 patients who underwent sleeve gastrectomy and met the inclusion criteria. The prepared mobilization program was applied to the patients on the 0th, 1st, and 2nd postoperative days, and the gastrointestinal functions of the patients were monitored. RESULTS: The intervention group had a significantly shorter time to first flatus, defecation, and oral intake; higher frequency of defecation; lower pain, abdominal distention, and nausea; better tolerance of oral intake; and higher total oral intake compared to the control group (p < 0.05). CONCLUSION: Planned, early, and targeted mobilization was determined to be a feasible, safe, and cost-effective nursing intervention to prevent gastrointestinal complications in patients undergoing sleeve gastrectomy.

[Effect of jejunal feeding tube placement on complications after laparoscopic radical surgery in patients with incomplete pyloric obstruction by gastric antrum cancer].

Objective: To assess the effect of jejunal feeding tube placement on early complications of laparoscopic radical gastrectomy in patients with incomplete pyloric obstruction by gastric cancer. Methods: This was a retrospective cohort study. Perioperative clinical data of 151 patients with gastric antrum cancer complicated by incomplete pyloric obstruction who had undergone laparoscopic distal radical gastrectomy from May 2020 to May 2022 in the First Affiliated Hospital of Nanchang University were collected. Intraoperative jejunal feeding tubes had been inserted in 69 patients (nutrition tube group) and not in the remaining 82 patients (conventional group). There were no statistically significant differences in baseline characteristics between the two groups (all P>0.05). The operating time, intraoperative bleeding, time to first intake of solid food, time to passing first flatus, time to drainage tube removal, and postoperative hospital stay, and early postoperative complications (occurded within 30 days after surgery) were compared between the two groups. Results: Patients in both groups completed the surgery successfully and there were no deaths in the perioperative period. The operative time was longer in the nutritional tube group than in the conventional group [(209.2±4.7) minutes vs. (188.5±5.7) minutes, t=2.737, P=0.007], whereas the time to first postoperative intake of food [(2.7±0.1) days vs. (4.1±0.4) days, t=3.535, P<0.001], time to passing first flatus [(2.3±0.1) days vs. (2.8±0.1) days, t=3.999, P<0.001], time to drainage tube removal [(6.3±0.2) days vs. (6.9±0.2) days, t=2.123, P=0.035], and postoperative hospital stay [(7.8±0.2) days vs. (9.7±0.5) days, t=3.282, P=0.001] were shorter in the nutritional tube group than in the conventional group. There was no significant difference between the two groups in intraoperative bleeding [(101.1±9.0) mL vs. (111.4±8.7) mL, t=0.826, P=0.410]. The overall incidence of short-term postoperative complications was 16.6% (25/151). Postoperative complications did not differ significantly between the two groups (all P>0.05). Conclusion: It is safe and feasible to insert a jejunal feeding tube in patients with incomplete outlet obstruction by gastric antrum cancer during laparoscopic radical gastrectomy. Such tubes confer some advantages in postoperative recovery.

Combination of thoracic epidural analgesia with patient-controlled intravenous analgesia versus traditional thoracic epidural analgesia for postoperative analgesia and early recovery of laparotomy: a prospective single-centre, randomized controlled trial.

BACKGROUND: Thoracic epidural analgesia (TEA) has always been the first choice for postoperative pain treatment, but associated complications and contraindications may limit its use. Our study put forward a new analgesic strategy that combines TEA with patient controlled intravenous analgesia (PCIA) to optimize TEA. METHODS: Patients undergoing laparotomy were enrolled in this prospective randomized study. Patients were randomized to one of two groups: TEA/PCIA group and TEA group. Patients in TEA/PCIA group received TEA in the day of surgery and the first postoperative day and PCIA continued to use until the third postoperative day. Patients in TEA group received TEA for three days postoperatively. Visual analogue scale (VSA) pain scores at rest and on movement at 6, 24,48,72 h after surgery were recorded. In addition, the incidence of inadequate analgesia, adverse events, time to first mobilization, time to pass first flatus, time of oral intake recovery, time of urinary catheter removal, postoperative length of hospital stay, cumulative opioid consumption, and the overall cost were compared between the two groups. We examined VAS pain scores using repeated measures analysis of variance; P < 0.05 was considered as statistically significant. RESULTS: Eighty-six patients were analysed (TEA/PCIA = 44, TEA = 42). The mean VAS pain scores at rest and on movement in TEA/PCIA group were lower than TEA group, with a significant difference on movement and 48 h postoperatively (P < 0.05). The time to first mobilization and pass first flatus were shorter in TEA/PCIA group (P < 0.05). Other measurement showed no statistically significant differences. CONCLUSIONS: The combination of TEA with PCIA for patients undergoing laparotomy, can enhance postoperative pain control and facilitate early recovery without increasing the incidence of adverse effects and overall cost of hospitalization. TRIAL REGISTRATION: Chinese Clinical Trial Registry( www.chictr.org.cn ), ChiCTR 1,800,020,308, 13 December 2018.

A pilot study on preoperative vascular anatomy and clinical application in rectal cancer resection.

AIM: To assess the utility of preoperatively evaluating the vascular anatomy using multisection spiral computed tomography angiography (CTA) and image fusion technology in the treatment of obese patients undergoing laparoscopic radical resection for rectal cancer. MATERIALS AND METHODS: This randomised prospective study included 56 patients who underwent laparoscopic surgery for rectal cancer. Patients were randomly divided into two groups: the fusion imaging group (preoperative CTA and image fusion reconstruction [n=28]) and the control group (not performed CTA and image fusion reconstruction before the operation [n=28]). Duration of surgery was defined as the primary endpoint, and the volume of bleeding, the number of lymph node dissections, conversion to laparotomy, time to recovery of postoperative flatus, length of hospitalisation as well as perioperative complications were defined as secondary endpoints. RESULTS: Compared with the control group, the duration of surgery in the image fusion group was shorter, bleeding volume was reduced, and the number of lymph node dissections was greater (p<0.05); however, there was no significant differences between the two groups regarding time to postoperative flatus recovery, conversion to laparotomy, length of hospitalisation, and perioperative complications (p>0.05). CONCLUSIONS: Preoperative assessment of the vascular anatomy was an effective method and avoided some invisible risks during surgery, and resulted in a better therapeutic effect.

Gut-brain axis dysfunction underlies FODMAP-induced symptom generation in irritable bowel syndrome.

BACKGROUND: FODMAPs produce similar small bowel water and colonic gas in patients with irritable bowel syndrome (IBS) and healthy controls (HCs), despite IBS patients reporting increased gastrointestinal (GI) symptoms. AIM: To unravel the mechanisms underlying FODMAP-induced symptom reporting, we investigated gut and brain responses to fructan administration in IBS patients and HC. METHODS: This randomised, double-blind, cross-over study consisted of three visits where fructans (40 g/500 mL saline), glucose (40 g/500 mL saline) or saline (500 mL) were infused intragastrically during 1 h MR brain scanning; abdominal MRI was performed before, 1 h, and 2 h post-infusion. Symptoms were rated using validated scales. RESULTS: In IBS (n = 13), fructans induced more cramps, pain, flatulence and nausea compared to glucose (P = 0.03, 0.001, 0.009 and <0.001 respectively), contrary to HC (n = 13) (all P > 0.14), with between-group differences for cramps and nausea (P = 0.004 and 0.023). Fructans increased small bowel motility and ascending colonic gas and volume equally in IBS and HC (between-group P > 0.25). The difference in colonic gas between fructans and saline covaried with differences in bloating and cramps in IBS (P = 0.008 and 0.035 respectively). Pain-related brain regions responded differentially to fructans in IBS compared to HC, including the cerebellum, supramarginal gyrus, anterior and midcingulate cortex, insula and thalamus (pFWE-corrected  < 0.05); these brain responses covaried with symptom responses in IBS. CONCLUSIONS: Fructans increase small bowel motility and colon gas and volume similarly in IBS patients and HC. Increased symptom responses to fructans in IBS covary with altered brain responses in pain-related regions, indicating that gut-brain axis dysregulation may drive FODMAP-induced symptom generation in IBS.

Complete mesogastric excision for locally advanced gastric cancer: short-term outcomes of a randomized clinical trial.

Implementation of complete mesogastric excision in gastric cancer surgery, named D2 lymphadenectomy plus complete mesogastric excision (D2+CME), has recently been proposed as an optimal procedure. However, the safety and efficacy of D2+CME remain uncertain. In this randomized controlled trial, patients receiving D2+CME exhibit less intraoperative blood loss, more lymph node harvesting, and earlier postoperative flatus than patients receiving conventional D2 radical surgery. Univariate Cox regression analysis reveals that the risk ratio for postoperative flatus in D2+CME group is 1.247 (p = 0.044). Overall postoperative complications are comparable between the two groups, but complications are significantly less severe in the D2+CME group than the D2 group (Clavien-Dindo classification grade ≥ IIIa: 4 D2+CME patients [11.8%] versus 9 D2 patients [33.3%]; p = 0.041). In conclusion, our work shows that D2+CME is associated with better short-term outcomes and surgical safety than conventional D2 dissection for patients with advanced gastric cancer.

67-year-old woman • excessive flatulence • persistent heartburn • chronic cough • Dx?

► Excessive flatulence, belching, and bloating ► Persistent heartburn ► Chronic cough.

Randomised Controlled Trial: Partial Hydrolysation of Casein Protein in Milk Decreases Gastrointestinal Symptoms in Subjects with Functional Gastrointestinal Disorders.

Unspecific gastrointestinal symptoms associated with milk consumption are common. In addition to lactose, also other components of milk may be involved. We studied whether the partial hydrolysation of milk proteins would affect gastrointestinal symptoms in subjects with functional gastrointestinal disorders. In a randomised, placebo-controlled crossover intervention, subjects (n = 41) were given ordinary or hydrolysed high-protein, lactose-free milkshakes (500 mL, 50 g protein) to be consumed daily for ten days. After a washout period of ten days, the other product was consumed for another ten days. Gastrointestinal symptoms were recorded daily during the study periods, and a validated irritable bowel syndrome-symptom severity scale (IBS-SSS) questionnaire was completed at the beginning of the study and at the end of both study periods. Blood and urine samples were analysed for markers of inflammation, intestinal permeability and immune activation. Both the IBS-SSS score (p = 0.001) and total symptom score reported daily (p = 0.002) were significantly reduced when participants consumed the hydrolysed product. Less bloating was reported during both study periods when compared with the baseline (p < 0.01 for both groups). Flatulence (p = 0.01) and heartburn (p = 0.03) decreased when consuming the hydrolysed product but not when drinking the control product. No significant differences in the levels of inflammatory markers (tumor necrosis factor alpha, TNF-α and interleukin 6, IL-6), intestinal permeability (fatty acid binding protein 2, FABP2) or immune activation (1-methylhistamine) were detected between the treatment periods. The results suggest that the partial hydrolysation of milk proteins (mainly casein) reduces subjective symptoms to some extent in subjects with functional gastrointestinal disorders. The mechanism remains to be resolved.

UK national cohort of anal cancer treated with intensity-modulated radiotherapy: One-year oncological and patient-reported outcomes.

BACKGROUND: Concurrent chemoradiotherapy is the standard treatment for anal cancer. Following national UK implementation of intensity-modulated radiotherapy (IMRT), this prospective, national cohort evaluates the one-year oncological outcomes and patient-reported toxicity outcomes (PRO) after treatment. MATERIALS AND METHODS: A national cohort of UK cancer centers implementing IMRT was carried out between February to July 2015. Cancer centers provided data on oncological outcomes, including survival, and disease and colostomy status at one-year. EORTC-QLQ core (C30) and colorectal (CR29) questionnaires were completed at baseline and one-year followup. The PRO scores at baseline and one year were compared. RESULTS: 40 UK Cancer Centers returned data with a total of 187 patients included in the analysis. 92% received mitomycin with 5-fluorouracil or capecitabine. One-year overall survival was 94%; 84% were disease-free and 86% colostomy-free at one-year followup. At one year, PRO results found significant improvements in buttock pain, blood and mucus in stools, pain, constipation, appetite loss, and health anxiety compared to baseline. No significant deteriorations were reported in diarrhea, bowel frequency, and flatulence. Urinary symptom scores were low at one year. Moderate impotence symptoms at baseline remained at one year, and a moderate deterioration in dyspareunia reported. CONCLUSIONS: With national anal cancer IMRT implementation, at this early pre-defined time point, one-year oncological outcomes were reassuring and resulted in good disease-related symptom control. one-year symptomatic complications following CRT for anal cancer using IMRT techniques appear to be relatively mild. These PRO results provide a basis to benchmark future studies.

Flatulence After Anti-reflux Treatment (FAART) Study.

BACKGROUND: Flatulence is known to be a common side effect of laparoscopic fundoplication, yet the true incidence is unclear and its impact on patients' quality of life not well understood. This study aimed to assess the long-term incidence of flatulence, and its effect on quality of life, following fundoplication. METHODS: All patients who underwent primary laparoscopic fundoplication between 1999 and 2009 were identified from a prospectively maintained institutional database. A cross-sectional analysis of post-operative gastrointestinal symptoms and quality of life was performed using a symptom-specific questionnaire. Statistical analysis of outcomes stratified by sex and type of fundoplication was performed. RESULTS: 462 eligible patients were identified from the database, with follow-up obtained in 265 (57%). Median age at surgery was 53 (22-78) years. 137 patients (52%) were female. 138 (52%) underwent a 360° fundoplication, the remainder a partial fundoplication. At median follow-up of 11 (8-15) years, excessive flatulence was reported by 85%. Only 12% reported an adverse impact on social life, and 11% an adverse impact on quality of life. Flatulence was worse following a total than partial fundoplication, women reported more gas-related symptoms than men, yet neither sex nor wrap type had a significant impact on social life or quality of life. CONCLUSIONS: The majority of patients report excessive flatulence at long-term follow-up after anti-reflux surgery, yet the impact on social life and quality life was small. There was no evidence to support tailoring of wrap type by sex to avoid gas-related symptoms. The authors advocate that all patients understand the inevitable side effects of fundoplication to help manage expectations from surgery.

Transverse colon duplication with chronic constipation in adult.

Gastrointestinal duplications are extremely rare congenital abnormalities having definite difficulties to be diagnosed preoperatively. Most of them are presented at the oesophagus and ileum and only involve colon from 4% to 18%. We illustrate a case report of an 18-year-old female patient with transverse colon duplication. There were symptom manifestations such as chronic constipation with flatulence accompanied with abdominal pain. We demonstrate this case report due to non-specific clinical presentation and some difficulties to form preoperative diagnosis. The patient underwent surgery. Tubular transverse colon duplication communicated with normal bowel in the proximal part was revealed. We performed transverse colon resection with duplication. The postoperative period was uneventful.

Gas, Bloating, and Belching: Approach to Evaluation and Management.

Gas, bloating, and belching are associated with a variety of conditions but are most commonly caused by functional gastrointestinal disorders. These disorders are characterized by disordered motility and visceral hypersensitivity that are often worsened by psychological distress. An organized approach to the evaluation of symptoms fosters trusting therapeutic relationships. Patients can be reliably diagnosed without exhaustive testing and can be classified as having gastric bloating, small bowel bloating, bloating with constipation, or belching disorders. Functional dyspepsia, irritable bowel syndrome, and chronic idiopathic constipation are the most common causes of these disorders. For presumed functional dyspepsia, noninvasive testing for Helicobacter pylori and eradication of confirmed infection (i.e., test and treat) are more cost-effective than endoscopy. Patients with symptoms of irritable bowel syndrome should be tested for celiac disease. Patients with chronic constipation should have a rectal examination to evaluate for dyssynergic defecation. Empiric therapy is a reasonable initial approach to functional gastrointestinal disorders, including acid suppression with proton pump inhibitors for functional dyspepsia, antispasmodics for irritable bowel syndrome, and osmotic laxatives and increased fiber for chronic idiopathic constipation. Nonceliac sensitivities to gluten and other food components are increasingly recognized, but highly restrictive exclusion diets have insufficient evidence to support their routine use except in confirmed celiac disease.

Severity of Diverticulitis Does Not Influence Abdominal Complaints during Long-Term Follow-Up.

BACKGROUND: Diverticulitis can lead to localized or generalized peritonitis and consequently induce abdominal adhesion formation. If adhesions would lead to abdominal complaints, it might be expected that these would be more prominent after operation for perforated diverticulitis with peritonitis than after elective sigmoid resection. AIMS: The primary outcome of the study was the incidence of abdominal complaints in the long-term after acute and elective surgery for diverticulitis. METHODS: During the period 2003 through 2009, 269 patients were operated for diverticular disease. Two hundred eight of them were invited to fill out a questionnaire composed of the gastrointestinal quality of life index and additional questions and finally 109 were suitable for analysis with a mean follow-up of 7.5 years. RESULTS: Analysis did not reveal any significant differences in the incidence of abdominal complaints or other parameters. CONCLUSION: This retrospective study on patients after operation for diverticulitis shows that in the long term, the severity of the abdominal complaints is influenced neither by the stage of the disease nor by the fact of whether it was performed in an acute or elective setting.

Effectiveness and tolerability of linaclotide in the treatment of IBS-C in a "real-life" setting: Results from a Portuguese single-center study.

BACKGROUND: Although linaclotide has been approved to treat moderate to severe IBS-C, no data are available on its effectiveness and tolerability in patients in a real-life setting. METHODS: A prospective single-center study of the effectiveness and tolerability of linaclotide was carried out on patients (n = 40) with moderate to severe IBS-C, all fulfilling the Rome IV criteria. Clinical information was recorded using a dietary questionnaire at baseline, and 3 and 6 months after initiating treatment. The end-points to measure effectiveness included abdominal pain and bloating (11-NRS), the number of bowel movements and patient satisfaction. Tolerability was assessed through the frequency of adverse events. KEY RESULTS: In terms of efficacy, an improvement in abdominal pain and in the intensity of bloating was evident in the cohort after 6 months of linaclotide therapy. The proportion of patients with moderate or severe symptoms of bloating fell from 93.3% to 33.3% and those with pain from 93.4% to 20%. Weekly bowel movements also improved and accordingly, 97% of the patients were moderately or very satisfied with the treatment. At the end of the study, diarrhea was the most frequent adverse event (10%), although it was considered mild in 66.7% of these subjects and moderate in 33.3%. A lack of efficacy (n = 3) and excessive diarrhea (n = 7) were motives for discontinuing the treatment. CONCLUSIONS AND INFERENCES: Linaclotide proved to be a safe and effective drug to reduce the main symptoms of IBS-C in everyday clinical practice, with an improvement comparable to that seen in clinical trials.

Anterior resection syndrome: What should we tell practitioners and patients in 2018?

Multidisciplinary management of infra-peritoneal rectal cancer has pushed back the frontiers of sphincter preservation, without impairment of carcinological outcome. However, functional intestinal sequelae, grouping together several symptoms known under the name of anterior resection syndrome (ARS), have emerged and become an increasingly frequent concern for both patients and physicians. The pathophysiology is complex: ARS is a combination in various degrees of stool frequency, incontinence for flatus and/or stools, urgency, and disorders in discrimination and evacuation. The "Low Anterior Resection Score" (LARS), validated in 2012, is currently used to evaluate the severity of ARS and its impact on quality of life. While ARS can show improvement over the first two years, symptoms persist for longer than two years in nearly 60% of patients and in half of these patients, ARS is considered severe. The most frequently reported independent risk factors of severe ARS include neo-adjuvant radiation therapy, the extent of resection (total mesorectal excision that includes inter-sphincteric resection), absence of colonic pouch and anastomotic leak. In the absence of surgical complications and/or local recurrence, physicians can draw from a wide therapeutic armamentarium in order to improve the functional outcome of patients, including diet and lifestyle modifications, gut motility regulators, multimodal rehabilitation (biofeedback, electro-stimulation) and sacral nerve modulation. Permanent colostomy is an alternative of last resort, proposed only when all other solutions fail. A better understanding of the natural history of ARS, its risk factors as well as the array of therapeutic alternatives should provide better patient information and optimize management.

Fermentable Sugar Ingestion, Gas Production, and Gastrointestinal and Central Nervous System Symptoms in Patients With Functional Disorders.

BACKGROUND & AIMS: Functional gastrointestinal disorders (FGID) are defined by broad phenotypic descriptions and exclusion of recognizable disease. FGIDs cause multi-organ symptoms and abnormal results in a wide range of laboratory tests, indicating broad mechanisms of pathogenesis. Many patients with FGID develop symptoms following ingestion of fermentable sugars; we investigated the associations between symptoms and intestinal gas production following sugar provocation tests to elucidate mechanisms of FGID. METHODS: We performed fructose and lactose breath tests in 2042 patients with a diagnosis of FGID (based on Rome III criteria), referred to a gastroenterology practice from January 2008 through December 2011. Medical and diet histories were collected from all subjects. Breath samples were collected before and each hour after, for 5 hours, subjects ingested fructose (35 g) and lactose (50 g) dissolved in 300 mL water. Hydrogen and methane gas concentrations were measured and GI and non-GI symptoms were registered for 5 hours following sugar ingestion. Symptom and gas time profiles were compared, treelet transforms were used to derive data-related symptom clusters, and the symptom severity of the clusters were analyzed for their association with breath gas characteristics. RESULTS: We identified 11 GI and central nervous system (CNS) symptom profiles and hydrogen and methane breath concentrations that changed significantly with time following sugar ingestion. Treelet transform analysis identified 2 distinct clusters, based on GI and CNS symptoms. The severity scores for the GI and CNS symptoms correlated following ingestion of sugars (all, P < .0001). However, only the GI symptoms associated with hydrogen and methane gas production (all, P < .0001). CONCLUSIONS: In an analysis of breath test results from more than 2000 patients with FGIDs, we identified clusters of GI and CNS symptoms in response to fructose of lactose ingestion. The association between specific symptoms and breath gas concentrations indicate distinct mechanisms of FGID pathogenesis, such as changes in the microbiome or mechanical and chemical sensitization. ClinicalTrials.gov ID: NCT02085889.

Does Bismuth Subgallate Affect Smell and Stool Character? A Randomized Double-Blinded Placebo-Controlled Trial of Bismuth Subgallate on Loop Duodenal Switch Patients with Complaints of Smelly Stools and Diarrhea.

BACKGROUND: Loop duodenal switch (LDS) can result in fat and starch malabsorption. In a small percentage of patients, a relevant qualitative and quantitative change in stools happens usually characterized by steatorrhea-like diarrhea. Bismuth subgallate (BS) has been marketed as a way to eliminate the odor associated with flatulence and bowel movements. The objective of this study is to see the efficacy and effect of BS on the quality of life (QOL) in patients undergoing LDS. METHODS: A prospective, randomized, double-blinded, placebo-controlled, crossover study was designed. Thirty-six patients who reported flatus and/or stool odor changes and have completed at least 6 months post-LDS were included. Patients participated in two treatment periods, each lasting for 1 week, separated by 1-week washout. Patients received 200 mg BS, 2 capsules per meal, or placebo for 1 week each. The Gastrointestinal Quality of Life Index (GIQLI) questionnaire was used to compare the QOL before the initiation of the therapy and after each treatment completion. RESULTS: Of 36 patients, 5 patients were lost to follow-up and 2 were withdrawn from the study. And 29 patients were included for final analysis. GIQLI scores obtained with BS treatment completion were significantly higher both overall (P = 0.007) and in the digestive domain (P < 0.001) than those obtained before the treatment. GIQLI scores obtained from the other domains were also higher compared to the pre-treatment as well as placebo treatment but not statistically significant. CONCLUSION: In our double-blinded trial, treatment with BS after LDS statistically improves GIQLI score and steatorrhea-like symptoms.