Trial reportUnited European gastroenterology journal2022
Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn's disease: Results of the HOT-TOPIC trial after 1-year follow-up.
Trial report in United European gastroenterology journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Efficacy and safety of tumor necrosis factor-α inhibitors and mesenchymal stem cells in the treatment of fistulizing Crohn's disease: a systematic review and network meta-analysis.Frontiers in immunology · 2026Pooled it
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn's disease: Results of the HOT-TOPIC trial after 1-year follow-up.United European gastroenterology journal · 2022Trial
- Medical Therapies Beyond Infliximab for Perianal Fistulizing Crohn's Disease: Current Evidence and Future Perspectives.Journal of clinical medicine · 2026Review
- Impaired keratinization activity in perianal Crohn's fistulas is associated with poor prognosis.Journal of Crohn's & colitis · 2026Article
- Indications, therapeutic modalities and clinical outcomes of hyperbaric oxygen therapy in Italy, the ITA-OTI Study: a multicentre prospective observational study.Journal of anesthesia, analgesia and critical care · 2026Article
- Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China.Intestinal research · 2026Article
- Hyperbaric Oxygen Therapy in the Management of Refractory Perianal Crohn's Disease.Journal of clinical medicine · 2025Article
- Hyperbaric Oxygen Therapy in the Treatment of Crohn's Disease.Healthcare (Basel, Switzerland) · 2025Article
- Management and Treatment of Perianal Fistulizing Crohn's Disease.Clinical and experimental gastroenterology · 2025Review
- The Potential Role of Hyperbaric Oxygen Therapy in Patients With Inflammatory Bowel Disease.Gastroenterology & hepatology · 2024Article
- Navigating the complexities of perianal Crohn's disease: Diagnostic strategies, treatment approaches, and future perspectives.World journal of gastroenterology · 2024Article
- Perianal disease in inflammatory bowel disease: Broadening treatment and surveillance strategies for anal cancer.World journal of gastroenterology · 2024Review
- Article
- Hyperbaric oxygen therapy ameliorates intestinal and systematic inflammation by modulating dysbiosis of the gut microbiota in Crohn's disease.Journal of translational medicine · 2024Article
- Hyperbaric Oxygen Therapy for Refractory Perianal Crohn's Disease: A Case Report.Gastroenterology & hepatology · 2024Article
- The new insights of hyperbaric oxygen therapy: focus on inflammatory bowel disease.Precision clinical medicine · 2024Review
- The effects of hyperbaric treatment on perianal fistula activity in patients with Crohn's disease.Przeglad gastroenterologiczny · 2024Article
- Surgical Management of Perianal Crohn's Disease: Current Evidence and Future Directions.Acta informatica medica : AIM : journal of the Society for Medical Informatics of Bosnia & Herzegovina : casopis Drustva za medicinsku informatiku BiH · 2024Article
- Crohn's Disease-Associated and Cryptoglandular Fistulas: Differences and Similarities.Journal of clinical medicine · 2023Review
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreviously 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.
objectiveTo assess the long-term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease.
methodsCrohn'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.
resultsTwenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (co-primary 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.
conclusionsThe 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.
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