Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study
The treatment of cryptoglandular anal fistula (AF) is often a challenge for surgeons. Several sphincter-saving procedures have been described as an alternative to fistulotomy, with the common goal of promoting healing and preserve anal continence. The aim of this proof of concept study was to assess...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-03-01
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| Series: | Frontiers in Surgery |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fsurg.2022.869923/full |
| _version_ | 1818287149655523328 |
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| author | Ugo Grossi Ugo Grossi Maurizio Romano Serena Rossi Gaetano Gallo Arcangelo Picciariello Carla Felice Diletta Trojan Giulia Montagner Giacomo Zanus Giacomo Zanus |
| author_facet | Ugo Grossi Ugo Grossi Maurizio Romano Serena Rossi Gaetano Gallo Arcangelo Picciariello Carla Felice Diletta Trojan Giulia Montagner Giacomo Zanus Giacomo Zanus |
| author_sort | Ugo Grossi |
| collection | DOAJ |
| description | The treatment of cryptoglandular anal fistula (AF) is often a challenge for surgeons. Several sphincter-saving procedures have been described as an alternative to fistulotomy, with the common goal of promoting healing and preserve anal continence. The aim of this proof of concept study was to assess the outcomes of human amniotic membrane (HAM) implantation in cryptoglandular transphincteric AF. Two consecutive female were recruited. The primary outcome was clinical healing at 6 months. Secondary outcomes were ultrasonographic healing, complications and reinterventions, AF symptoms, fecal incontinence, psychological impact of treatment, recurrence, development of additional AF, patient satisfaction, and quality of life, as measured using validated questionnaires. Both patients (40 and 54-year-old) previously underwent incision and drainage of anal abscess with concomitant seton placement. HAM implantation was performed as a day case under local anesthesia. No intra- or post-procedural complications occurred. Clinical and radiological healing were not achieved at 6 months. However, the external outlet discharge diminished through time, with sustained improvements in quality of life. Clinical healing occurred at 7 months in both patients. Psychological impact of treatment and patient satisfaction were overall good, with improvements in the PHQ-9, GAD-7, and Short Assessment of Patients Satisfaction. HAM implantation is safe and improves patients' quality of life, progressively leading to clinical healing. Future studies are needed to assess its safety in other etiology of AF. |
| first_indexed | 2024-12-13T01:35:54Z |
| format | Article |
| id | doaj.art-d36337dc2ce84988a9d9f69535137e1a |
| institution | Directory Open Access Journal |
| issn | 2296-875X |
| language | English |
| last_indexed | 2024-12-13T01:35:54Z |
| publishDate | 2022-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Surgery |
| spelling | doaj.art-d36337dc2ce84988a9d9f69535137e1a2022-12-22T00:03:54ZengFrontiers Media S.A.Frontiers in Surgery2296-875X2022-03-01910.3389/fsurg.2022.869923869923Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept StudyUgo Grossi0Ugo Grossi1Maurizio Romano2Serena Rossi3Gaetano Gallo4Arcangelo Picciariello5Carla Felice6Diletta Trojan7Giulia Montagner8Giacomo Zanus9Giacomo Zanus10II Surgery Unit, Regional Hospital Treviso, Treviso, ItalyDepartment of Surgery, Oncology and Gastroenterology - DISCOG, University of Padua, Padua, ItalyII Surgery Unit, Regional Hospital Treviso, Treviso, ItalyDepartment of Surgery, Oncology and Gastroenterology - DISCOG, University of Padua, Padua, ItalyDepartment of Medicine, Surgery and Neurosciences, Unit of General Surgery and Surgical Oncology, University of Siena, Siena, ItalySurgical Unit ‘M. Rubino', Department of Emergency and Organ Transplantation, University ‘Aldo Moro of Bari', Bari, ItalyDepartment of Medicine - DIMED, University of Padua, Padua, ItalyTreviso Tissue Bank Foundation, Treviso, ItalyTreviso Tissue Bank Foundation, Treviso, ItalyII Surgery Unit, Regional Hospital Treviso, Treviso, ItalyDepartment of Surgery, Oncology and Gastroenterology - DISCOG, University of Padua, Padua, ItalyThe treatment of cryptoglandular anal fistula (AF) is often a challenge for surgeons. Several sphincter-saving procedures have been described as an alternative to fistulotomy, with the common goal of promoting healing and preserve anal continence. The aim of this proof of concept study was to assess the outcomes of human amniotic membrane (HAM) implantation in cryptoglandular transphincteric AF. Two consecutive female were recruited. The primary outcome was clinical healing at 6 months. Secondary outcomes were ultrasonographic healing, complications and reinterventions, AF symptoms, fecal incontinence, psychological impact of treatment, recurrence, development of additional AF, patient satisfaction, and quality of life, as measured using validated questionnaires. Both patients (40 and 54-year-old) previously underwent incision and drainage of anal abscess with concomitant seton placement. HAM implantation was performed as a day case under local anesthesia. No intra- or post-procedural complications occurred. Clinical and radiological healing were not achieved at 6 months. However, the external outlet discharge diminished through time, with sustained improvements in quality of life. Clinical healing occurred at 7 months in both patients. Psychological impact of treatment and patient satisfaction were overall good, with improvements in the PHQ-9, GAD-7, and Short Assessment of Patients Satisfaction. HAM implantation is safe and improves patients' quality of life, progressively leading to clinical healing. Future studies are needed to assess its safety in other etiology of AF.https://www.frontiersin.org/articles/10.3389/fsurg.2022.869923/fullsurgeryfistulaanalcryptoglandular anal fistulaamniotic membrane (AM) |
| spellingShingle | Ugo Grossi Ugo Grossi Maurizio Romano Serena Rossi Gaetano Gallo Arcangelo Picciariello Carla Felice Diletta Trojan Giulia Montagner Giacomo Zanus Giacomo Zanus Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study Frontiers in Surgery surgery fistula anal cryptoglandular anal fistula amniotic membrane (AM) |
| title | Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study |
| title_full | Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study |
| title_fullStr | Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study |
| title_full_unstemmed | Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study |
| title_short | Anal Fistula Human Amniotic Membrane Endosealing (F-HAME): A Proof of Concept Study |
| title_sort | anal fistula human amniotic membrane endosealing f hame a proof of concept study |
| topic | surgery fistula anal cryptoglandular anal fistula amniotic membrane (AM) |
| url | https://www.frontiersin.org/articles/10.3389/fsurg.2022.869923/full |
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