J Fassov, K L Høyer, L Lundby, S Laurberg, S M Scott, K Krogh
{"title":"骶神经调节治疗腹泻型和混合型肠易激综合征的长期疗效和安全性。","authors":"J Fassov, K L Høyer, L Lundby, S Laurberg, S M Scott, K Krogh","doi":"10.1007/s10151-024-03066-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Irritable bowel syndrome (IBS) is a very common condition worldwide. Treatment options for severe IBS are few. Sacral neuromodulation (SNM) for patients with IBS has been shown to reduce symptoms and improve quality of life in the medium term. This study aimed to evaluate the long-term effectiveness and safety of SNM in diarrhoea-predominant and mixed IBS.</p><p><strong>Methods: </strong>A prospective cohort of patients with IBS treated with SNM were evaluated 1, 3, 5, and 10 years after implantation. The primary end-point was a change in the Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome version questionnaire (GSRS-IBS) from baseline to 10-year follow-up (FU). Secondary end-points were change in the GSRS-IBS score from baseline to 5-year FU and change in the Irritable Bowel Syndrome-Impact Scale questionnaire (IBS-IS) from baseline to 5- and 10-year FU. Adverse events following SNM were observed.</p><p><strong>Results: </strong>Of 36 patients treated with SNM, 23 were eligible for 5-year FU and 13 for 10-year FU. The GSRS-IBS score was significantly reduced at both 5-year (p < 0.0001) and 10-year (p = 0.0007) FU. The IBS-IS score was also significantly improved at both 5 years (p < 0.0001) and 10 years (p = 0.0002). Fifty-six adverse events were registered. Five patients were explanted because of adverse events.</p><p><strong>Conclusion: </strong>SNM seems to offer an effective and safe treatment option for highly selected patients with diarrhoea-predominant and mixed IBS.</p><p><strong>Clinical trial registration: </strong>The present study has not been registered. The latest founding study was registered at ClinicalTrials.gov, NCT01948973.</p>","PeriodicalId":51192,"journal":{"name":"Techniques in Coloproctology","volume":"29 1","pages":"41"},"PeriodicalIF":2.7000,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome.\",\"authors\":\"J Fassov, K L Høyer, L Lundby, S Laurberg, S M Scott, K Krogh\",\"doi\":\"10.1007/s10151-024-03066-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Irritable bowel syndrome (IBS) is a very common condition worldwide. Treatment options for severe IBS are few. Sacral neuromodulation (SNM) for patients with IBS has been shown to reduce symptoms and improve quality of life in the medium term. This study aimed to evaluate the long-term effectiveness and safety of SNM in diarrhoea-predominant and mixed IBS.</p><p><strong>Methods: </strong>A prospective cohort of patients with IBS treated with SNM were evaluated 1, 3, 5, and 10 years after implantation. The primary end-point was a change in the Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome version questionnaire (GSRS-IBS) from baseline to 10-year follow-up (FU). Secondary end-points were change in the GSRS-IBS score from baseline to 5-year FU and change in the Irritable Bowel Syndrome-Impact Scale questionnaire (IBS-IS) from baseline to 5- and 10-year FU. Adverse events following SNM were observed.</p><p><strong>Results: </strong>Of 36 patients treated with SNM, 23 were eligible for 5-year FU and 13 for 10-year FU. The GSRS-IBS score was significantly reduced at both 5-year (p < 0.0001) and 10-year (p = 0.0007) FU. The IBS-IS score was also significantly improved at both 5 years (p < 0.0001) and 10 years (p = 0.0002). Fifty-six adverse events were registered. Five patients were explanted because of adverse events.</p><p><strong>Conclusion: </strong>SNM seems to offer an effective and safe treatment option for highly selected patients with diarrhoea-predominant and mixed IBS.</p><p><strong>Clinical trial registration: </strong>The present study has not been registered. The latest founding study was registered at ClinicalTrials.gov, NCT01948973.</p>\",\"PeriodicalId\":51192,\"journal\":{\"name\":\"Techniques in Coloproctology\",\"volume\":\"29 1\",\"pages\":\"41\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-01-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Techniques in Coloproctology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10151-024-03066-3\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Techniques in Coloproctology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10151-024-03066-3","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Long-term efficacy and safety of sacral neuromodulation for diarrhoea-predominant and mixed irritable bowel syndrome.
Background: Irritable bowel syndrome (IBS) is a very common condition worldwide. Treatment options for severe IBS are few. Sacral neuromodulation (SNM) for patients with IBS has been shown to reduce symptoms and improve quality of life in the medium term. This study aimed to evaluate the long-term effectiveness and safety of SNM in diarrhoea-predominant and mixed IBS.
Methods: A prospective cohort of patients with IBS treated with SNM were evaluated 1, 3, 5, and 10 years after implantation. The primary end-point was a change in the Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome version questionnaire (GSRS-IBS) from baseline to 10-year follow-up (FU). Secondary end-points were change in the GSRS-IBS score from baseline to 5-year FU and change in the Irritable Bowel Syndrome-Impact Scale questionnaire (IBS-IS) from baseline to 5- and 10-year FU. Adverse events following SNM were observed.
Results: Of 36 patients treated with SNM, 23 were eligible for 5-year FU and 13 for 10-year FU. The GSRS-IBS score was significantly reduced at both 5-year (p < 0.0001) and 10-year (p = 0.0007) FU. The IBS-IS score was also significantly improved at both 5 years (p < 0.0001) and 10 years (p = 0.0002). Fifty-six adverse events were registered. Five patients were explanted because of adverse events.
Conclusion: SNM seems to offer an effective and safe treatment option for highly selected patients with diarrhoea-predominant and mixed IBS.
Clinical trial registration: The present study has not been registered. The latest founding study was registered at ClinicalTrials.gov, NCT01948973.
期刊介绍:
Techniques in Coloproctology is an international journal fully devoted to diagnostic and operative procedures carried out in the management of colorectal diseases. Imaging, clinical physiology, laparoscopy, open abdominal surgery and proctoperineology are the main topics covered by the journal. Reviews, original articles, technical notes and short communications with many detailed illustrations render this publication indispensable for coloproctologists and related specialists. Both surgeons and gastroenterologists are represented on the distinguished Editorial Board, together with pathologists, radiologists and basic scientists from all over the world. The journal is strongly recommended to those who wish to be updated on recent developments in the field, and improve the standards of their work.
Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1965 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted. Reports of animal experiments must state that the Principles of Laboratory Animal Care (NIH publication no. 86-23 revised 1985) were followed as were applicable national laws (e.g. the current version of the German Law on the Protection of Animals). The Editor-in-Chief reserves the right to reject manuscripts that do not comply with the above-mentioned requirements. Authors will be held responsible for false statements or for failure to fulfill such requirements.