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BackgroundMast cell activation is thought to be involved in visceral hypersensitivity, one of the main characteristics of the irritable bowel syndrome (IBS). A study was therefore undertaken to investigate the effect of the mast cell stabiliser ketotifen on rectal sensitivity and symptoms in patients with IBS.Methods60 patients with IBS underwent a barostat study to assess rectal sensitivity before and after 8 weeks of treatment. After the initial barostat, patients were randomised to receive ketotifen or placebo. IBS symptoms and health-related quality of life were scored. In addition, mast cells were quantified and spontaneous release of tryptase and histamine was determined in rectal biopsies and compared with biopsies from 22 age- and gender-matched healthy volunteers.ResultsKetotifen but not placebo increased the threshold for discomfort in patients with IBS with visceral hypersensitivity. This effect was not observed in normosensitive patients with IBS. Ketotifen significantly decreased abdominal pain and other IBS symptoms and improved quality of life. The number of mast cells in rectal biopsies and spontaneous release of tryptase were lower in patients with IBS than in healthy volunteers. Spontaneous release of histamine was mostly undetectable but was slightly increased in patients with IBS compared with healthy volunteers. Histamine and tryptase release were not altered by ketotifen.ConclusionsThis study shows that ketotifen increases the threshold for discomfort in patients with IBS with visceral hypersensitivity, reduces IBS symptoms and improves health-related quality of life. Whether this effect is secondary to the mast cell stabilising properties of ketotifen or H1 receptor antagonism remains to be further investigated.Trial Registration NumberNTR39, ISRCTN22504486.

Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. The aim of this study was to investigate the optimal dose frequency, clinical effects, and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. Patients with FI were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1, 5, or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensorimotor function, and quality of life were compared. Primary outcome measure was the change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. Thirty-three patients with FI participated. FI episodes decreased significantly (∆ ±95% confidence interval, 4.2 ± 2.8 (1 Hz); 2 ± 1.7 (5 Hz); 3.4 ± 2.5 (15 Hz); P < 0.02) in all 3 groups when compared with baseline. The 1 Hz group showed a significantly higher (P = 0.04) responder rate (91 ± 9.1%) when compared with the 5 Hz group (36 ± 18.2%) or 15 Hz (55 ± 18.2%); no difference was found between the 5 and 15 Hz groups (P = 0.667). Anal neuropathy, squeeze pressure, and rectal capacity improved significantly only in the 1 Hz (P < 0.05) group compared with baseline, but not in other groups. Quality of life domains improved significantly (P < 0.05) with 1 and 5 Hz groups. No device-related serious adverse events were noted. TNT significantly improves FI symptoms in the short term, and the 1 Hz frequency was overall better than 5 and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and noninvasive treatment for FI (see Visual Abstract, Supplementary Digital Content 3, http://links.lww.com/AJG/B598).

Background Constipation, a prevalent gastrointestinal disorder, affects 10%–15% of adults in the USA and approximately 8.2% of China’s general population. Slow transit constipation (STC), accounting for 15%–42% of constipation cases, is defined by impaired colonic motility. For patients refractory to conservative treatment who experience chronic, intractable symptoms and diminished quality of life, surgical intervention becomes the treatment of last resort. The primary surgical approach for STC has traditionally been total colectomy with ileorectal anastomosis (TC-IRA). However, over the past two decades, subtotal colectomy with cecorectal anastomosis (SC-CRA) has gained increasing attention among clinicians due to its potential to reduce postoperative diarrhea. Despite this advantage, SC-CRA is also associated with concerns regarding an increased risk of recurrent constipation. The debate surrounding which approach is superior persists. This study aims to resolve this controversy through a comparative analysis of TC-IRA and SC-CRA, evaluating their therapeutic efficacy and safety profiles in refractory STC. Methods The STOPS trial is a prospective, randomized, multicenter-controlled clinical trial to compare the effectiveness of TC-IRA versus SC-CRA in treating patients with STC. After screening for eligibility and obtaining informed consent, a total of 252 adult patients will be randomized into two groups in a 1:1 ratio after assuring that none of the exclusion criteria is present. The primary outcome is the Wexner Constipation Score. The secondary outcomes include operative time, conversion rates, blood loss, short- and long-term complications, bowel movements, abdominal pain, bloating, straining, enema use, laxative use, Wexner Incontinence Score, gastrointestinal quality of life index (GIQLI), 36-item Short Form Health Survey (SF-36), and satisfaction. Outcomes will be assessed at baseline and at 1, 3, 6, 12, 24, and 36 months postoperatively. Discussion This trial will be the first and largest randomized clinical trial to assess whether TC-IRA or SC-CRA should be the standardized surgical treatment for STC in terms of WCS outcomes. We hope that its findings will not only demonstrate the value of the surgical procedure in the treatment of STC, but also provide more reliable clinical evidence for further standardization of STC surgical treatment. Trial registration STOPS Trial: A Multicentre Prospective Randomised Clinical Trial Comparing Total Colectomy with Ileorectal Anastomosis Versus Subtotal Colectomy with Cecal-rectal Anastomosis for Slow Transit Constipation ( http://clinicaltrials.gov/ct2/show/NCT05352074 ). Registry identifier: NCT05352074. Registration date: April 3, 2022.

Biofeedback therapy is useful for treatment of functional defecation disorders but is not widely available and is labor intensive. We developed an Internet-of-Medical-Things (IoMT) device, enabling self-guided biofeedback therapy. This study assesses the safety and efficacy of self-guided biofeedback therapy using the IoMT device in comparison to standard operator-led therapy. Patients experiencing urge or seepage fecal incontinence (≥1 episode/week) were randomly assigned to either our IoMT system or to the conventional anorectal manometry-based therapy. Both interventions comprised six weekly sessions, focusing on enhancing anal strength, endurance, and coordination. The novel device facilitated self-guided therapy via visual instructions on a companion app. Primary outcomes included safety/tolerability, changes in Vaizey severity scores, and alterations in anorectal pressure profiles. Twenty-five patients (22 females, 3 males) participated, with 13 in the novel device group and 12 in the standard therapy group. Both groups showed significant reductions in symptom severity scores: IoMT device group -4.2 (95% CI: -4.06, -4.34, p = 0.018), and the standard therapy group -4.8 (95% CI: -4.31, -5.29, p = 0.028). Anal sphincter resting pressure and sustained squeeze time improved significantly in both groups, and the novel device group demonstrated an increase in maximum sphincter squeeze pressure. There were no significant differences between the therapy groups. Importantly, the experimental device was well-tolerated compared with standard therapy, with no serious adverse events observed. This study demonstrates the comparable efficacy of self-administered biofeedback using the IoMT device with traditional biofeedback therapy. The results demonstrates the potential of the IoMT device as a safe, self-guided method for FI therapy, offering convenience and effectiveness in fecal incontinence management.

Background Probiotics have treatment efficacy in irritable bowel syndrome (IBS), but the exact mechanism remains obscure. One hypothesis is the mediation of melatonin levels, leading to changes in IBS symptoms. Aim The purpose of this study was to evaluate the effects of a probiotic, VSL#3, on symptoms, psychological and sleep parameters, and pain sensitivity in IBS, and relate these parameters to in vivo melatonin levels. Methods Forty-two IBS patients were randomly assigned to receive VSL#3 or placebo for 6 weeks. Subjects completed bowel and psychological questionnaires, underwent rectal sensitivity testing and saliva melatonin assays. Results Abdominal pain duration and distension intensity decreased significantly in the probiotic group, along with an increase in rectal distension pain thresholds. A correlation between increase in pain tolerance and improvement in abdominal pain scores ( r  = 0.51, p  = 0.02) was seen with probiotic. There was an increase in salivary morning melatonin levels in males treated with VSL#3, which correlated ( r  = 0.61) with improved satisfaction in bowel habits. When grouped based on baseline diurnal melatonin levels, patients with normal diurnal fluctuations showed an increase in morning melatonin levels with VSL#3 treatment, which significantly correlated with improved satisfaction in bowel habits ( r  = 0.68). They also had reduced symptom severity scores and abdominal pain duration when treated with VSL#3, as well as satisfaction with bowel movements and quality-of-life. Conclusions VSL#3 improved symptoms and increased rectal pain thresholds. Symptom improvement correlated with a rise in morning melatonin, significant in males and subjects with normal circadian rhythm. This suggests that probiotics may act by influencing melatonin production, hence modulating IBS symptoms, in individuals with a normal circadian rhythm.

The objective of this study was to show that although transcutaneous electrical tibial nerve stimulation (TENS) is being increasingly used to treat fecal incontinence (FI), its efficacy has never been proved using controlled trials. In this randomized, double-blind, sham-controlled trial, 144 patients aged 30-82 years from nine centers were randomly assigned to receive either active or sham stimulations for 3 months. The primary end point was the response to treatment based on the number of incontinence and urgency episodes. Secondary end points were severity scores, quality of life scores, delay to postpone defecation, patient self-assessment of treatment efficacy, physician assessment of TENS efficacy, anorectal manometry, and adverse events. No statistically significant difference was seen between active and sham TENS in terms of an improvement in the median number of FI/urgency episodes per week. Thirty-four patients (47%) who received the active TENS treatment exhibited a >30% decrease in the FI severity score compared with 19 patients (27%) who received the sham treatment (odds ratio 2.4, 95% confidence interval 1.1-5.1, P=0.02). No differences in delay to postpone defecation, patient self-assessment of treatment efficacy, or anorectal manometry were seen between the two groups. The evaluating physicians rated the active stimulations as more effective than the sham stimulations (P=0.01). One minor therapy-related adverse event was observed (1.5%) (see Supplementary Consort 1b). We failed to demonstrate any benefit of TENS on our primary end-point.

Background Some Chinese scholars have initially explored the efficacy of electroacupuncture at Baliao acupoint in patients with functional anorectal pain (FAP). However, their studies are performed in a single center, or the sample size is small. Therefore, we aim to further explore the efficacy of electroacupuncture at Baliao acupoint on the treatment of FAP. Methods In this multicenter randomized controlled trial, 136 eligible FAP patients will be randomly allocated into an electroacupuncture group or sham electroacupuncture group at a 1:1 ratio. This trial will last for 34 weeks, with 2 weeks of baseline, 4 weeks and 8 weeks of treatment, and 1, 3, and 6 months of follow-up. Outcome assessors and statisticians will be blind. The primary outcome will be clinical treatment efficacy, and secondary outcomes will be pain days per month, quality of life, psychological state assessment, anorectal manometry, pelvic floor electromyography, and patient satisfaction. Discussion Results of this trial will be contributed to further clarify the value of electroacupuncture at Baliao acupoint as a treatment for FAP in the clinic. Trial registration This trial has been registered in Chinese Clinical Trial Registry  https://www.chictr.org.cn/  (ChiCTR2300069757) on March 24, 2023.

Background and aims: Irritable bowel syndrome (IBS) is a disorder of intestinal hypersensitivity and altered motility, exacerbated by stress. Functional magnetic resonance imaging (fMRI) during painful rectal distension in IBS has demonstrated greater activation of the anterior cingulate cortex (ACC), an area relevant to pain and emotions. Tricyclic antidepressants are effective for IBS. The aim of this study was to determine if low dose amitriptyline reduces ACC activation during painful rectal distension in IBS to confer clinical benefits. Secondary aims were to identify other brain regions altered by amitriptyline, and to determine if reductions in cerebral activation are greater during mental stress. Methods: Nineteen women with painful IBS were randomised to amitriptyline 50 mg or placebo for one month and then crossed over to the alternate treatment after washout. Cerebral activation during rectal distension was compared between placebo and amitriptyline groups by fMRI. Distensions were performed alternately during auditory stress and relaxing music. Results: Rectal pain induced significant activation of the perigenual ACC, right insula, and right prefrontal cortex. Amitriptyline was associated with reduced pain related cerebral activations in the perigenual ACC and the left posterior parietal cortex, but only during stress. Conclusions: The tricyclic antidepressant amitriptyline reduces brain activation during pain in the perigenual (limbic) anterior cingulated cortex and parietal association cortex. These reductions are only seen during stress. Amitriptyline is likely to work in the central nervous system rather than peripherally to blunt pain and other symptoms exacerbated by stress in IBS.

Study design: Randomized, controlled clinical trial. Objectives: Bladder and bowel management may cause serious autonomic dysreflexia (AD) in subjects with high spinal cord injury (SCI). We aimed at investigating autonomic responses to digital rectal evacuation (DE), transanal irrigation (TAI) with 500 ml and filling cystometry (FC) in SCI. Setting: Aarhus University Hospital, Denmark. Methods: Eight subjects with SCI (AIS A) at or above T6 (high SCI) and a previous history of AD were compared with three subjects with SCI (AIS A) between T10 and L2 (low SCI). In randomized order, DE, TAI and FC were performed. AD was defined as an acute rise in systolic blood pressure (sBP) of ⩾30 mm Hg above baseline. Blood levels of norepinephrine and epinephrine were determined before and shortly after the procedures. Results: During all three procedures, AD occurred in all patients with high SCI but not in those with low SCI. In high SCI subjects, DE increased median sBP from 127 (range: 86–154) to 188 (range: 140–206) mm Hg ( P <0.02), TAI from 126 (range: 91–146) to 163 (range: 130–188) mm Hg ( P <0.02) and FC from 125 (range: 106–149) to 200 (range: 179–220) mm Hg ( P <0.01). The sBP increase was lower during TAI than during DE ( P <0.05) or FC ( P <0.02). In high SCI subjects, the blood levels of norepinephrine, but not those of epinephrine, increased significantly during all three stimuli (all P <0.05). Conclusion: Bowel and bladder management caused AD in high SCI. The response is less severe during TAI than during FC or DE.

Background This study was carried out to investigate the effect of perioperative high oxygen concentration on surgical site infection (SSI) in patients undergoing elective colorectal surgery. Methods This was a single-center, prospective, parallel arm, double-blind, superiority randomized controlled trial. All patients more than 18 years of age undergoing elective colorectal surgery were included as per the inclusion criteria. Patients were randomized at the time of induction of anesthesia into high concentration and standard concentration oxygen group based on the concentration of oxygen. Incidence of SSI, day of the detection of SSI, grade of SSI, incidence of anastomotic leak, postoperative day of return of bowel functions, day of starting oral feeds, day of ambulation, and length of hospitalization were studied in both the groups. Results A total of 94 patients were included in the study, 47 patients each in high concentration oxygen group and standard concentration oxygen group respectively. The SSI rates were comparable between the two groups [55.3% (95% CI—4.012–69.83) vs. 40.4% (95% CI—26.37–55.73); p  = 0.215]. There was no significant difference found with respect to mean day of detection of SSI [4.5(IQR—3.0–7.5) vs. 6.0 (IQR—3.0–9.0; p  = 0.602], postoperative day of return of bowel functions (2.20 ± 0.542 vs. 2.13 ± 0.582; p  = 0.540), oral feeds (3.62 ± 0.945 vs. 3.46 ± 1.048; p  = 0.544), ambulation (4.17 ± 0.868 vs. 4.17 ± 1.270; p  = 0.987), and the length of hospitalization [15(IQR—10–19) vs. 15(IQR—10.75–18.25); p  = 0.862] between the two groups. Conclusion There was no significant difference in the rate of SSI with the use of perioperative high oxygen concentration in patients undergoing elective colorectal surgery.