There is a considerable delay in diagnosis for female Dutch patients with LS. The Skindex-29 domain scores showed a moderately impaired HRQoL. Women with LS reported a lower generic HRQoL than the average female Dutch population.
20 Crohn's disease patients with therapy‐refractory fistulas were treated with 40 sessions of hyperbaric oxygen therapy. At week 16 a significant improvement in clinical, radiological and biochemical outcomes was seen.
Background Metastatic Crohn’s disease (CD) is a rare manifestation of CD. It involves inflammatory skin lesions with histopathological findings (granulomas) similar to CD, without connection to the gastrointestinal tract. Hyperbaric oxygen therapy (HBO) has been suggested as a possible treatment option. Objective This study aimed to identify and treat a consecutive series of patients with biopsy-proven metastatic CD and monitor wound healing using prospectively acquired outcomes. Methods Pathology results of all patients with ongoing perineal wound-healing problems after proctectomy between 2005 and 2018 at the Amsterdam University Medical Centre were assessed for metastatic CD. Patients with a biopsy-proven diagnosis of perineal metastatic CD were offered HBO (40 daily sessions of 100% oxygen at 2.4 atmosphere absolute). Wound healing was monitored using photographs and standardised questionnaires (the Inflammatory Bowel Disease Questionnaire, EuroQol Visual Analogue Scale and the Female Sexual Function Index) at baseline and 1 and 3 months after HBO. Results Out of 13 patients in the cohort with persisting perineal wounds after proctectomy, six (46%) had biopsy results consistent with metastatic CD. Of these, three accepted treatment with HBO. All three patients were female. One patient had complete healing of her perineal wound; another patient showed initial improvement but had a flare of luminal and perineal disease at the 3-month follow-up. The third patient showed improvement solely in the questionnaires, with higher scores on all three questionnaires. Conclusion A high rate of metastatic CD was found in patients with ongoing wound-healing problems after proctectomy, implying that the disease might not be as rare in these selected patients as previously thought. HBO might be beneficial in the treatment of metastatic CD.
Background: Structured evaluation of magnetic resonance imaging (MRI) is important to guide clinical decisions of perianal fistulas in Crohn's disease (CD) patients. Purpose: To evaluate the recently developed modified Van Assche index to assess clinical responses to anti-tumor necrosis factor (TNF) therapy in patients with perianal fistulizing CD. Methods: A search of medical records identified patients with fistulizing perianal CD who underwent baseline and follow-up MRI while receiving anti-TNF treatment. Patients were divided into clinical responders and nonresponders based on physician's assessment. MRI-scans were scored using the original and modified Van Assche index and scores between baseline and follow-up were compared within clinical responders and non-responders. Results: Thirty cases were included (48% female, median age 27 years). Clinical responders (n = 16) had a median modified Van Assche score of 9.6 (IQR 5.8-12.7) at baseline and 5.8 (IQR 3.5-8.5) at follow-up (p = 0.008). In non-responders (n = 14), corresponding scores were 7.7 (IQR 5.8-13.5) and 8.2 (IQR 5.8-11.5) (p = 0.624). In clinical responders, 6/16 showed no drop in modified Van Assche score at follow-up. Scores obtained with the original Van Assche index dropped between baseline and follow-up in clinical responders (13.0 vs. 9.6, p = 0.011), whereas no decrease was observed in non-responders (11.5 vs. 11.5, p = 0.324). Conclusions: While the modified Van Assche index overall decreases significantly in patients with perianal fistulas responding to anti-TNF treatment, one third of responders had unaltered scores at follow-up. Also, outcomes were comparable to the original Van Assche index. Further optimization of the modified Van Assche index is needed before application in larger studies. Recently, Samaan et al. modified this index to increase objective reflection of clinical responses and in order to improve interrater and
Background: Perianal fistulizing Crohn’s disease (pCD) has a significant impact on patients’ health and quality of life. Current treatment options have a relatively low success rate and a high recurrence risk. Positive effects of hyperbaric oxygen (HBO2) therapy have been indicated in animal studies as well as in small case series. Methods/Design: This is a non-randomized, controlled pilot study. A total of 20 patients with pCD who have been refractory to standard therapy for at least six months will be included. Patients with a seton and stable treatment regimen will be included. Patients with anal strictures, rectovaginal fistulas, stoma or deep ulceration of the rectum will be excluded. Patients who are eligible but refuse HBO2 will be asked to serve as controls. Patients in the HBO2 group will be treated with 40 sessions of HBO2 therapy at 243-253 kPa, with the seton being removed after 30 sessions. Co-primary endpoints are changes in the perianal disease activity index and MRI-scores. Secondary outcomes are fistula drainage assessment, laboratory findings and patient-reported outcomes. Assessment will be done at baseline, 16 weeks, 34 weeks and 60 weeks after finishing HBO2. Discussion: The aim of this study is to investigate the feasibility and therapeutic effect of HBO2 on pCD. The oneyear follow-up should provide information on the effect durability. A comparison between patients treated with HBO2 and patients who continue to receive standard care will be made. The risk of bias will be limited by using clearly defined inclusion and exclusion criteria, baseline characteristics and consecutive recruitment of patients through an outpatient fistula clinic. Trial registration: The HOT-TOPIC trial has been approved by the local Medical Ethical Committee of the Academic Medical Centre in Amsterdam, the Netherlands. The trial has been registered at the Netherlands Trial Register (www.trialregister.nl), registration number: NTR 6676. Protocol version: August 2017, version 3.0.
Background Positive effects of hyperbaric oxygen (HBO) on perianal fistulas in Crohn’s disease (CD) have been described, but the effect on rectovaginal fistulas (RVFs) has not yet been studied. The aim was to investigate the efficacy, safety and feasibility of HBO in patients with RVF in CD. Methods In this prospective study, consecutive CD patients between November 2018 and February 2020 presenting with RVF at the outpatient fistula clinic of the Amsterdam University Medical Centre were included and selected to receive treatment with 30 daily HBO sessions, if fistulas were actively draining and any concomitant treatment regimen was stable at least 6 weeks prior to start of HBO. Patients with a stoma were excluded. The primary endpoint was clinical closure at 3-month follow-up, defined as cessation of complaints and/or closure of the external orifice if visible at baseline. Secondary outcomes were improvement of concomitant perianal fistulas as measured by the perianal disease activity index (PDAI) and fistula drainage assessment (FDA), as well as improvement in patient-reported outcomes (visual analogue scale (VAS), inflammatory bowel disease questionnaire (IBDQ), faecal incontinence quality of life scale (FIQL) and female sexual functioning index (FSFI)) at 3-month follow-up. Results Out of 14 eligible patients, nine patients (median age 50 years) were treated, all of whom had previously had one or more unsuccessful medical and/or surgical treatments for their RVF. Clinical closure occurred in none of the patients at 3-month follow-up. There was no improvement in PDAI and patient-reported outcomes (VAS, IBDQ, FIQL and FSFI). Two patients had concomitant perianal fistulas; using FDA, one patient had a clinical response and one patient was in clinical remission 3 months after HBO. There were two treatment-related adverse events during HBO concerning claustrophobia and fatigue. Furthermore, two patients had a surgical intervention due to RVF and two patients were treated with antibiotics for a urinary tract infection during follow-up. One patient had a dose reduction of ustekinumab because of decreased luminal complaints. Conclusion Treatment with HBO was feasible, but in this therapy-refractory cohort without deviating ostomy no clinical closure of RVF or improvement in quality of life was seen 3 months after HBO. Treatment with HBO alone in this specific group of patients therefore appears to be ineffective.
Background: Previously published short-term results (week 16) of this trial showed a significant improvement in clinical, radiologic and biochemical outcomes in Crohn's disease patients with therapy-refractory perianal fistulas after treatment with hyperbaric oxygen therapy.Objective: To assess the long-term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease.Methods: Crohn's disease patients with high perianal fistula(s) failing conventional treatment >6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received 40 hyperbaric oxygen sessions and outcomes were assessed at week 16 and week 60.Results: Twenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (coprimary outcomes) decreased from 7.5 (95% CI 6-9) to 4 (95% CI 3-6, p < 0.001) and 9.2 (95% CI 7.3-11.2) to 7.3 (95% CI 6.9-9.7, p = 0.004), respectively. At week 60, the respective scores remained significantly lower than baseline: 4 (95% CI 3-7, p < 0.001) and 7.7 (95% CI 5.2-10.2, p = 0.003). Perianal disease activity index score of 4 or less (representing inactive perianal disease) was observed in 13 patients at week 16 and 12 patients at week 60. Using fistula drainage assessment, 12 and 13 patients showed a clinical response at week 16 and 60, respectively, and clinical remission was achieved in four patients for both time points. At week 16, a statistically significant biochemical improvement (C-reactive protein and faecal calprotectin levels) was found, but this effect was no longer significant at week 60. Conclusions:The clinical and radiologic improvement of perianal fistula in Crohn's disease, that was found at week 16 after treatment with hyperbaric oxygen therapy, is maintained at 1-year follow-up.
Dermal injection of fillers is a popular and relatively safe aesthetic procedure. Severe complications are rare, but they do occur. One of the most threatening complications after dermal filler injection is skin necrosis due to vascular occlusion. Different treatment options are available, including the use of hyperbaric oxygen (HBO2) therapy. A 46-year-old female received facial dermal filler injections with calcium hydroxylapatite at an aesthetic clinic. A few days after injection she developed a burning pain, numbness of the skin and white discoloration in the injected area. Two days after injection treatment was started with hyaluronidase and warm compresses. In addition, the patient received prednisolone, sildenafil and nifedipine. After the start of these treatments, the pain, numbness and discoloration of the skin persisted. Because of dermal ischemia and to improve healing she was referred for HBO2. Treatment consisted of 10 sessions of 100% oxygen for 90 minutes in a multiplace chamber at 2.5 atmospheres absolute pressure. During HBO2 the discoloration resolved, pain and numbness disappeared, and the tissue healed completely. After a six-month follow-up she had an excellent cosmetic outcome. Given the pathophysiologic mechanisms of vascular complications after dermal filler injection, HBO2 should be considered when treating these complications.
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