C Sabbagh, F Mauvais, M Demouron, F Browet, L Tartar, H Hariz, V Bridoux, J-J Tuech, M Diouf, J-M Regimbeau
{"title":"回肠袢造口需要桥（棒）吗？一项II期随机对照试验。","authors":"C Sabbagh, F Mauvais, M Demouron, F Browet, L Tartar, H Hariz, V Bridoux, J-J Tuech, M Diouf, J-M Regimbeau","doi":"10.1007/s10151-025-03132-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The value of a bridge in loop ileostomies is debated. We aimed to evaluate whether using a bridge when creating a loop ileostomy can reduce morbidity following an ileostomy.</p><p><strong>Methods: </strong>Patients who had a loop ileostomy after elective colorectal surgery from January 2016 to July 2022 were randomized in this multicenter phase 2 randomized superiority trial. The primary endpoint was the absence of postoperative stomal complications at 2 months and was assessed in a blinded fashion by a stoma therapist. Secondary endpoints were morbidity at 1 month and the STOMA-QOL score at 2 months.</p><p><strong>Results: </strong>During the study period, 67 patients were randomized to the bridge group and 63 to the no-bridge group. Epidemiological and perioperative data did not differ between the two groups. The stomal complication-free rate was 76% in the bridge group and 67% in the no-bridge group (p = 0.3). There was no difference in the distribution of complications at 1 month according to the Clavien-Dindo score (p = 0.2) or the STOMA-QOL score at 2 months (p = 0.4) between the two groups.</p><p><strong>Conclusion: </strong>The bridge does not reduce the rate of stomatal complications, nor does it appear to reduce patients' quality of life.</p><p><strong>Trial registration number: </strong>NCT02756273 (May 10, 2016).</p>","PeriodicalId":51192,"journal":{"name":"Techniques in Coloproctology","volume":"29 1","pages":"87"},"PeriodicalIF":2.9000,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11937139/pdf/","citationCount":"0","resultStr":"{\"title\":\"Is a bridge (rod) necessary for loop ileostomy? A phase II randomized control trial.\",\"authors\":\"C Sabbagh, F Mauvais, M Demouron, F Browet, L Tartar, H Hariz, V Bridoux, J-J Tuech, M Diouf, J-M Regimbeau\",\"doi\":\"10.1007/s10151-025-03132-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The value of a bridge in loop ileostomies is debated. We aimed to evaluate whether using a bridge when creating a loop ileostomy can reduce morbidity following an ileostomy.</p><p><strong>Methods: </strong>Patients who had a loop ileostomy after elective colorectal surgery from January 2016 to July 2022 were randomized in this multicenter phase 2 randomized superiority trial. The primary endpoint was the absence of postoperative stomal complications at 2 months and was assessed in a blinded fashion by a stoma therapist. Secondary endpoints were morbidity at 1 month and the STOMA-QOL score at 2 months.</p><p><strong>Results: </strong>During the study period, 67 patients were randomized to the bridge group and 63 to the no-bridge group. Epidemiological and perioperative data did not differ between the two groups. The stomal complication-free rate was 76% in the bridge group and 67% in the no-bridge group (p = 0.3). There was no difference in the distribution of complications at 1 month according to the Clavien-Dindo score (p = 0.2) or the STOMA-QOL score at 2 months (p = 0.4) between the two groups.</p><p><strong>Conclusion: </strong>The bridge does not reduce the rate of stomatal complications, nor does it appear to reduce patients' quality of life.</p><p><strong>Trial registration number: </strong>NCT02756273 (May 10, 2016).</p>\",\"PeriodicalId\":51192,\"journal\":{\"name\":\"Techniques in Coloproctology\",\"volume\":\"29 1\",\"pages\":\"87\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-03-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11937139/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Techniques in Coloproctology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10151-025-03132-4\",\"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/s10151-025-03132-4","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Is a bridge (rod) necessary for loop ileostomy? A phase II randomized control trial.
Background: The value of a bridge in loop ileostomies is debated. We aimed to evaluate whether using a bridge when creating a loop ileostomy can reduce morbidity following an ileostomy.
Methods: Patients who had a loop ileostomy after elective colorectal surgery from January 2016 to July 2022 were randomized in this multicenter phase 2 randomized superiority trial. The primary endpoint was the absence of postoperative stomal complications at 2 months and was assessed in a blinded fashion by a stoma therapist. Secondary endpoints were morbidity at 1 month and the STOMA-QOL score at 2 months.
Results: During the study period, 67 patients were randomized to the bridge group and 63 to the no-bridge group. Epidemiological and perioperative data did not differ between the two groups. The stomal complication-free rate was 76% in the bridge group and 67% in the no-bridge group (p = 0.3). There was no difference in the distribution of complications at 1 month according to the Clavien-Dindo score (p = 0.2) or the STOMA-QOL score at 2 months (p = 0.4) between the two groups.
Conclusion: The bridge does not reduce the rate of stomatal complications, nor does it appear to reduce patients' quality of life.
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.
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