Explore the vast range of titles available.

Complex perianal fistulas in Crohn's disease are challenging to treat. Allogeneic, expanded, adipose-derived stem cells (Cx601) are a promising new therapeutic approach. We aimed to assess the safety and efficacy of Cx601 for treatment-refractory complex perianal fistulas in patients with Crohn's disease. We did this randomised, double-blind, parallel-group, placebo-controlled study at 49 hospitals in seven European countries and Israel from July 6, 2012, to July 27, 2015. Adult patients (≥18 years) with Crohn's disease and treatment-refractory, draining complex perianal fistulas were randomly assigned (1:1) using a pre-established randomisation list to a single intralesional injection of 120 million Cx601 cells or 24 mL saline solution (placebo), with stratification according to concomitant baseline treatment. Treatment was administered by an unmasked surgeon, with a masked gastroenterologist and radiologist assessing the therapeutic effect. The primary endpoint was combined remission at week 24 (ie, clinical assessment of closure of all treated external openings that were draining at baseline, and absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI). Efficacy was assessed in the intention-to-treat (ITT) and modified ITT populations; safety was assessed in the safety population. This study is registered with ClinicalTrials.gov, number NCT01541579. 212 patients were randomly assigned: 107 to Cx601 and 105 to placebo. A significantly greater proportion of patients treated with Cx601 versus placebo achieved combined remission in the ITT (53 of 107 [50%] vs 36 of 105 [34%]; difference 15·2%, 97·5% CI 0·2–30·3; p=0·024) and modified ITT populations (53 of 103 [51%] vs 36 of 101 [36%]; 15·8%, 0·5–31·2; p=0·021). 18 (17%) of 103 patients in the Cx601 group versus 30 (29%) of 103 in the placebo group experienced treatment-related adverse events, the most common of which were anal abscess (six in the Cx601 group vs nine in the placebo group) and proctalgia (five vs nine). Cx601 is an effective and safe treatment for complex perianal fistulas in patients with Crohn's disease who did not respond to conventional or biological treatments, or both. TiGenix.

Infliximab, a monoclonal antibody against tumor necrosis factor, reduces disease activity in patients with Crohn's disease. In this study of patients with fistulizing Crohn's disease who had a response to infliximab, continued infusions every 8 weeks were associated with a longer duration of response than were placebo infusions. After 54 weeks of treatment, 36 percent of patients in the infliximab group and 19 percent of those in the placebo group had no draining fistulas. Maintenance treatment reduced the likelihood of relapse. Fistulas occur in 17 to 43 percent of patients with Crohn's disease. 1 , 2 Perianal fistulas, the most common variant, decrease the quality of life and increase the likelihood of total colectomy. 3 Although widely used in the treatment of fistulas, antibiotics, immunomodulators, and dietary therapies have not been demonstrated to result in sustained closure of fistulas in Crohn's disease. 4 – 9 Surgical options are limited by the potential for compromise of anal continence. Surgical diversion of the fecal stream by a stoma often produces healing; however, many patients find a stoma to be undesirable, and the benefit of this approach is unlikely . . .

Objective:To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn’s disease (CD).Design:A phase III, multicentre, randomised, double-blind, placebo controlled study with an open-label extension was conducted in 92 sites.Patients:A subgroup of adults with moderate to severely active CD (CD activity index 220–450) for ⩾4 months who had draining fistulas at baseline.Interventions:All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at weeks 0/2). At week 4, all patients were randomly assigned to receive double-blind placebo or adalimumab 40 mg every other week or weekly to week 56 (irrespective of fistula status). Patients completing week 56 of therapy were then eligible to enroll in an open-label extension.Main Outcome Measures:Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression.Results:Of 854 patients enrolled, 117 had draining fistulas at both screening and baseline (70 randomly assigned to adalimumab and 47 to placebo). The mean number of draining fistulas per day was significantly decreased in adalimumab-treated patients compared with placebo-treated patients during the double-blind treatment period. Of all patients with healed fistulas at week 56 (both adalimumab and placebo groups), 90% (28/31) maintained healing following 1 year of open-label adalimumab therapy (observed analysis).Conclusions:In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.ClinicalTrials.gov Identifier: NCT00077779 and NCT00195715.

Obstetric fistula repair failure can result in increased depression, social isolation, financial burden for the woman, and fistula care programs. However, there is limited, comprehensive evidence on obstetric fistula repair failure in Sub-Saharan African countries. This systematic review and meta-analysis aimed to determine the pooled prevalence of obstetric fistula repair failure and associated factors among women who underwent surgical repair in Sub-Saharan African countries. To identify potential articles, a systematic search was done utilizing online databases (PubMed, Hinari, and Google Scholar). The Preferred Reporting Items for Systematic Review and Meta-Analysis Statement (PRISMA) guideline was used to report the review's findings. I2 test statistics were employed to examine study heterogeneity. A random-effects model was used to assess the pooled prevalence of obstetric fistula repair failure, and the association was determined using the log odds ratio. Publication bias was investigated using the funnel plot and Egger's statistical test at the 5% level of significance. Meta-regression and subgroup analysis were done to identify potential sources of heterogeneity. The data were analyzed using STATA version 17 statistical software. A total of 24 articles with 9866 study participants from 13 Sub-Saharan African countries were included in this meta-analysis. The pooled prevalence of obstetric fistula repair failure in sub-Saharan Africa was 24.92% [95% CI: 20.34-29.50%]. The sub-group analysis by country revealed that the highest prevalence was in Angola (58%, 95% CI: 53.20-62.80%) and the lowest in Rwanda (13.9, 95% CI: 9.79-18.01%). Total urethral damage [OR  =  3.50, 95% CI: 2.09, 4.91], large fistula [OR = 3.09, 95% CI: (2.00, 4.10)], duration of labor [OR = 0.45, 95% CI: 0.27, 0.76], and previous fistula repair [OR = 2.70, 95% CI: 1.94, 3.45] were factors associated with obstetric fistula repair failure. Women who received surgical treatment for obstetric fistulas in Sub-Saharan African countries experienced more repair failures than the WHO standards. Obstetric fistula repair failure was affected by urethral damage, fistula size, duration of labor, types of fistula, and history of previous repairs. Therefore, we suggest policy measures specific to each country to provide special attention to the prevention of all risk factors, including poor nutrition, multiparty, obstructed labor, and maternal age, which can result in conditions like large fistulas, urethral damage, and repeat repair, in order to reduce obstetric fistula repair failure.

Background The use of glutamine and arginine has shown several advantages in postoperative outcomes in patients after gastrointestinal surgery. We determined the effects of its use in patients with enterocutaneous fistula after operative treatment. Patients and Methods Forty patients with enterocutaneous fistula were randomly assigned to one of two groups. The control group received the standard medical care while the patients of the experimental group were supplemented with enteral administration of 4.5 g of arginine and 10 g of glutamine per day for 7 days prior to the surgery. The primary outcome variable was the recurrence of the fistula and the secondary outcomes were preoperative and postoperative serum concentrations of interleukin 6 and C-reactive protein and postoperative infectious complications. Results Twenty patients were assigned to each group. The fistula recurred in two patients (10%) of the experimental group and in nine patients (45%) of the control group ( P  < 0.001). We found a total of 13 infectious complications in six patients of the control group (all with fistula recurrence) and none in the experimental group. Mean preoperative serum concentrations of interleukin 6 and C-reactive protein were lower in patients from the experimental group. In addition, these levels were lower in patients who had recurrence if compared to patients that did not recur. Conclusion Preoperative administration of oral arginine and glutamine could be valuable in the postoperative recovery of patients with enterocutaneous fistulas submitted to definitive surgery.

Abstract Background This study sought to re-estimate the cumulative incidence of perianal or rectovaginal fistulas and the associated proctectomy rate in the prebiologic era vs the biologic era using a population-based cohort of Crohn's disease (CD) patients. Methods The medical records of 414 residents of Olmsted County, Minnesota, who were diagnosed with CD between 1970 and 2010 were reviewed. The cumulative incidence of perianal or rectovaginal fistulas from time of CD diagnosis and the cumulative rate of proctectomy from date of first perianal or rectovaginal fistula diagnosis were estimated using the Kaplan-Meier method. Results Eighty-five patients (20.5%) diagnosed with CD between 1970 and 2010 had at least 1 perianal or rectovaginal fistula episode between January 1, 1970, and June 30, 2016. The cumulative incidence of perianal or rectovaginal fistulas was 18% after 10 years, 23% after 20 years, and 24% after 30-40 years from CD diagnosis. The cumulative incidence of perianal or rectovaginal fistulas was significantly lower in patients diagnosed in 1998 or after than in patients diagnosed before 1998 (P = 0.03, log-rank). Among 85 patients developing perianal or rectovaginal fistulas, 16 patients (18.8%) underwent proctectomy for the treatment of perianal or rectovaginal fistulas during follow-up. Conclusions In a population-based inception cohort of CD, one-fifth of patients were diagnosed with at least 1 perianal or rectovaginal fistula. The cumulative probability of perianal or rectovaginal fistulizing disease has decreased over time. Video Abstract 10.1093/ibd/izy329_video1 izy329.video1 5850901975001

INTRODUCTION:Inferior Vena Cava (IVC) filters are primarily indicated for patients with a history of deep venous thrombosis (DVT) or pulmonary embolism (PE) who have contraindications to anticoagulation. In most patients, the indication for placement of a filter is temporary. Although filter penetration of the IVC wall has been reported to range from 9% to 24% for all IVC filters, symptomatic perforation is rare and is reported to occur in about 0.4%-0.8% of cases. We are presenting a rare case of duodenocaval fistula presenting as massive gastrointestinal bleeding.CASE DESCRIPTION/METHODS:A 39-year-old male with a history of motor vehicle accident 10 years ago resulting in paraplegia and multiple lower extremity DVTs which required the placement of an IVC filter at that time was admitted to the hospital with one day of nausea, vomiting and hematochezia. History was very concerning for high volume bright red bleeding per rectum with associated non-bilious vomiting and dizziness. On arrival, he was hypotensive with a blood pressure of 60/40 mmHg, physical examination significant for actively oozing bright red blood per rectum. Labwork was remarkable for a Hemoglobin of 7.0 mg/dL and a BUN of 35 mg/dL. A CT scan of abdomen/pelvis with contrast revealed an IVC filter strut travelling through the IVC wall and perforating to the adjacent small bowel with active extravasation of the IV contrast to the small bowel, suggestive of a fistulous communication between IVC and a perforated loop of bowel. The patient was emergently taken to the operating room for exploratory laparotomy. IVC filter strut was found to be eroding through the IVC and into the duodenum confirming the CT findings. Transverse venotomy was performed and the filter was removed. An area of small bowel serosal tear was incorporated into the enterectomy segment, and end to end small bowel anastomosis was performed. IVC was repaired, and hemostasis was secured. Post-operatively, patient stayed stable clinically and hemodynamically with cessation of hematochezia.DISCUSSION:Duodenocaval fistula is a very rare complication of IVC filter placement, with around 10 reported cases in the literature. Even though it is rare, our case highlights the importance of a thorough and timely sensitive workup for an unstable patient with gastrointestinal bleeding and history of an IVC filter placement to rule out IVC penetration into surrounding viscera, since this can lead to significant morbidity and mortality if not recognized early during the clinical course.

Gastrointestinal fistulas are increasingly being encountered in our clinical practice because of the increased burden of Crohn’s disease, bariatric surgeries, interventional endoscopic procedures, nonsurgical trauma, and war and disaster zones worldwide. Presentation depends on the location and specific type of the fistula. Symptomatic ones can have a tremendous impact on social life and can cause dehydration, electrolyte imbalance, malnutrition, increased morbidity, and mortality. Different imaging studies and endoscopic procedures are done to establish the diagnosis. Treatment modalities to close the fistula depend on the underlying disease and the type of fistula. They include conservative treatment, medical therapy, endoscopic interventions, and surgery. Currently, there is no accepted treatment algorithm due to a lack of controlled clinical trials. The prognosis varies from fistula to fistula, and the mortality can be as high as 50%.