{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T12:29:09Z","timestamp":1765196949995,"version":"3.46.0"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T00:00:00Z","timestamp":1765152000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T00:00:00Z","timestamp":1765152000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Tech Coloproctol"],"published-print":{"date-parts":[[2026,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Perianal fistulas often require multiple surgical interventions because of their chronic nature. Various sphincter-sparing techniques achieve clinical closure rates of up to 70%, yet recurrence remains a major challenge. Vacuum-assisted closure (VAC) therapy has shown promise in wound healing, but its application in perianal fistulas remains largely unexplored. The Semiflex catheter was developed to facilitate outpatient vacuum therapy without the need for general anesthesia during catheter exchanges. This pilot study aimed to evaluate the feasibility and clinical applicability of the Semiflex catheter in perianal fistula management.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The Semiflex pilot study was a two-part feasibility trial. The first part assessed proof of principle in ten patients, while the second part, a multicentre study, aimed to confirm feasibility in 20 patients. Feasibility included smoothness of insertion and changing of the Semiflex catheters, capability of proper fixation of the Semiflex catheter, maintaining vacuum for more than 48\u00a0h, and compliance to the therapy in terms of pain and discomfort. The protocol was scored feasible if at least 50% of the exchanges met all these criteria in at least 70% of patients. Secondary outcomes included clinical fistula closure, radiological healing, and treatment-related adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Twenty patients were included (median age 39.5\u00a0years; 70% Crohn\u2019s disease). Thirteen Semiflex treatments were scored as feasible, below the predefined threshold. Clinical fistula closure was observed in 50% of patients, but none showed radiological healing at 3\u00a0months. One serious adverse event occurred, requiring early treatment discontinuation, while minor complications, including local skin reactions and pressure sores, were managed conservatively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Semiflex therapy was feasible in a subset of patients and allowed outpatient treatment. However, maintaining vacuum and achieving long-term fistula closure remains challenging. While Semiflex may have a role in perianal fistula management, further research is needed to refine patient selection and optimize its application.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10151-025-03240-1","type":"journal-article","created":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T12:24:05Z","timestamp":1765196645000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Semiflex-assisted vacuum therapy for perianal fistulas: the Semiflex pilot study"],"prefix":"10.1007","volume":"30","author":[{"given":"A. J. M.","family":"Pronk","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. Y.","family":"van Oostendorp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I. J. M.","family":"Han-Geurts","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Madelska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C. J.","family":"Buskens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. A.","family":"Bemelman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"Semiflex Research Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Madelski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Br\u0119eczewski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K.","family":"Przybylska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Micha\u0142owska","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Banasiewicz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"ten Bokkel-Huinink","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Barnier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"van Langen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,12,8]]},"reference":[{"issue":"1","key":"3240_CR1","doi-asserted-by":"publisher","first-page":"370","DOI":"10.1186\/s12955-020-01622-7","volume":"18","author":"SO Adegbola","year":"2020","unstructured":"Adegbola SO, Dibley L, Sahnan K et al (2020) Burden of disease and adaptation to life in patients with Crohn\u2019s perianal fistula: a qualitative exploration. Health Qual Life Outcomes 18(1):370","journal-title":"Health Qual Life Outcomes"},{"issue":"5","key":"3240_CR2","doi-asserted-by":"publisher","first-page":"334","DOI":"10.1308\/rcsann.2016.0136","volume":"98","author":"HA Owen","year":"2016","unstructured":"Owen HA, Buchanan GN, Schizas A, Cohen R, Williams AB (2016) Quality of life with anal fistula. Ann R Coll Surg Engl 98(5):334\u2013338","journal-title":"Ann R Coll Surg Engl"},{"issue":"3","key":"3240_CR3","doi-asserted-by":"publisher","first-page":"231","DOI":"10.1002\/bjs5.50129","volume":"3","author":"ME Stellingwerf","year":"2019","unstructured":"Stellingwerf ME, van Praag EM, Tozer PJ, Bemelman WA, Buskens CJ (2019) Systematic review and meta-analysis of endorectal advancement flap and ligation of the intersphincteric fistula tract for cryptoglandular and Crohn\u2019s high perianal fistulas. BJS Open 3(3):231\u2013241","journal-title":"BJS Open"},{"issue":"10051","key":"3240_CR4","doi-asserted-by":"publisher","first-page":"1281","DOI":"10.1016\/S0140-6736(16)31203-X","volume":"388","author":"J Pan\u00e9s","year":"2016","unstructured":"Pan\u00e9s J, Garc\u00eda-Olmo D, Van Assche G et al (2016) Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn\u2019s disease: a phase\u00a03 randomised, double-blind controlled trial. Lancet 388(10051):1281\u20131290","journal-title":"Lancet"},{"issue":"Suppl_1","key":"3240_CR5","doi-asserted-by":"publisher","first-page":"i34","DOI":"10.1093\/ecco-jcc\/jjad212.0018","volume":"18","author":"Z Serclova","year":"2024","unstructured":"Serclova Z, Garcia-Olmo D, Chen ST et al (2024) OP18 efficacy and safety of darvadstrocel treatment in patients with complex perianal fistulas and Crohn\u2019s disease: results from the global ADMIRE-CD II phase\u00a03 study. J Crohns Colitis 18(Suppl_1):i34\u2013i35","journal-title":"J Crohns Colitis"},{"issue":"2","key":"3240_CR6","doi-asserted-by":"publisher","first-page":"151","DOI":"10.1080\/17434440.2021.1882301","volume":"18","author":"SJ Poteet","year":"2021","unstructured":"Poteet SJ, Schulz SA, Povoski SP, Chao AH (2021) Negative pressure wound therapy: device design, indications, and the evidence supporting its use. Expert Rev Med Devices 18(2):151\u2013160","journal-title":"Expert Rev Med Devices"},{"key":"3240_CR7","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1007\/5584_2023_773","volume":"1436","author":"T Yamashiro","year":"2023","unstructured":"Yamashiro T, Kushibiki T, Mayumi Y, Tsuchiya M, Ishihara M, Azuma R (2023) Negative-pressure wound therapy: what we know and what we need to know. Adv Exp Med Biol 1436:131\u2013152","journal-title":"Adv Exp Med Biol"},{"issue":"1","key":"3240_CR8","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1097\/01.ASW.0000547411.16017.58","volume":"32","author":"J Hermann","year":"2019","unstructured":"Hermann J, Banasiewicz T, Ko\u0142odziejczak B (2019) Role of vacuum-assisted closure in the management of Crohn anal fistulas. Adv Skin Wound Care 32(1):35\u201340","journal-title":"Adv Skin Wound Care"},{"issue":"5","key":"3240_CR9","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1093\/ecco-jcc\/jjab168","volume":"16","author":"KL van Rijn","year":"2022","unstructured":"van Rijn KL, Meima-van Praag EM, Bossuyt PM et al (2022) Fibrosis and MAGNIFI-CD activity index at magnetic resonance imaging to predict treatment outcome in perianal fistulizing Crohn\u2019s disease patients. J Crohns Colitis 16(5):708\u2013716","journal-title":"J Crohns Colitis"},{"key":"3240_CR10","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.102045","volume":"61","author":"EM Meima-van Praag","year":"2023","unstructured":"Meima-van Praag EM, Becker MAJ, van Rijn KL et al (2023) Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy alone for Crohn\u2019s perianal fistulas (PISA-II): long-term outcomes of an international, multicentre patient preference, randomised controlled trial. EClinicalMedicine 61:102045","journal-title":"EClinicalMedicine"},{"issue":"12","key":"3240_CR11","doi-asserted-by":"publisher","first-page":"2973","DOI":"10.1038\/ajg.2009.509","volume":"104","author":"SC Ng","year":"2009","unstructured":"Ng SC, Plamondon S, Gupta A et al (2009) Prospective evaluation of anti-tumor necrosis factor therapy guided by magnetic resonance imaging for Crohn\u2019s perineal fistulas. Am J Gastroenterol 104(12):2973\u20132986","journal-title":"Am J Gastroenterol"},{"issue":"10","key":"3240_CR12","doi-asserted-by":"publisher","first-page":"1825","DOI":"10.1002\/ibd.21940","volume":"18","author":"P Tozer","year":"2012","unstructured":"Tozer P, Ng SC, Siddiqui MR et al (2012) Long-term MRI-guided combined anti-TNF-\u03b1 and thiopurine therapy for Crohn\u2019s perianal fistulas. Inflamm Bowel Dis 18(10):1825\u20131834","journal-title":"Inflamm Bowel Dis"},{"issue":"6","key":"3240_CR13","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1097\/SLE.0000000000000216","volume":"25","author":"M Keskin","year":"2015","unstructured":"Keskin M, Bayram O, Bulut T, Balik E (2015) Effectiveness of endoluminal vacuum-assisted closure therapy (Endosponge) for the treatment of pelvic anastomotic leakage after colorectal surgery. Surg Laparosc Endosc Percutan Tech 25(6):505\u2013508","journal-title":"Surg Laparosc Endosc Percutan Tech"}],"container-title":["Techniques in Coloproctology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10151-025-03240-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10151-025-03240-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10151-025-03240-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T12:24:05Z","timestamp":1765196645000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10151-025-03240-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,8]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,12]]}},"alternative-id":["3240"],"URL":"https:\/\/doi.org\/10.1007\/s10151-025-03240-1","relation":{},"ISSN":["1123-6337","1128-045X"],"issn-type":[{"value":"1123-6337","type":"print"},{"value":"1128-045X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,8]]},"assertion":[{"value":"20 April 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 October 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 December 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This trial was conducted according to good clinical practice guidelines and the principles of the Declaration of Helsinki. This study has been registered on ClinicalTrials.gov under the identification number NCT06446635. The Semiflex Pilot Study has been approved by the Medical Ethical Committee of the Amsterdam UMC, Amsterdam in April 2023.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}],"article-number":"7"}}