Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone

Background The incidence of high-output stoma (HOS) was reported to be approximately 3 to 16% in the literature, and HOS can cause dehydration. This complication is often severe enough to warrant hospital readmission and may result in renal failure. The aim of this study was to show a decrease of 50...

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Main Authors: Yannis Mesli, Lise Holterbach, Jean-Baptiste Delhorme, Zaher Lakkis, Pablo Ortega-Deballon, Sophie Deguelte, Serge Rohr, Cécile Brigand, Nicolas Meyer, Benoit Romain
Format: Article
Language:English
Published: Taylor & Francis Group 2021-11-01
Series:Journal of Investigative Surgery
Subjects:
Online Access:http://dx.doi.org/10.1080/08941939.2020.1800871
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author Yannis Mesli
Lise Holterbach
Jean-Baptiste Delhorme
Zaher Lakkis
Pablo Ortega-Deballon
Sophie Deguelte
Serge Rohr
Cécile Brigand
Nicolas Meyer
Benoit Romain
author_facet Yannis Mesli
Lise Holterbach
Jean-Baptiste Delhorme
Zaher Lakkis
Pablo Ortega-Deballon
Sophie Deguelte
Serge Rohr
Cécile Brigand
Nicolas Meyer
Benoit Romain
author_sort Yannis Mesli
collection DOAJ
description Background The incidence of high-output stoma (HOS) was reported to be approximately 3 to 16% in the literature, and HOS can cause dehydration. This complication is often severe enough to warrant hospital readmission and may result in renal failure. The aim of this study was to show a decrease of 50% in ileostomy output in the experimental arm using lanreotide treatment. Methods Patients with an ileostomy output ≥ 1.5 l/24 hours were included in this prospective, open, multicentre randomized trial. Patients were randomly allocated between treatment arms with either lanreotide (LAN) and antidiarrhoeal treatments (TAD) (LAN-TAD group) or antidiarrhoeal treatments only (TADS group). The primary outcome was ileostomy output after 72 days. The secondary endpoints were ileostomy output during the first 6 days, blood urea and creatinine values, hospital length of stay and serious adverse events. Results In the per-protocol analysis, there were nine patients in the control group (TADS) and six patients in the experimental group (TAD-LAN group). The stoma outputs at Day 3 (D3) in the experimental and control groups were 1,900 ± 855.7 mL and 1,728.6 ± 845.5 mL, respectively (p = 0.2). No differences were found concerning stoma output at D6, renal function, or hospital length of stay between the two groups. Conclusion The trial was prematurely stopped due to the low number of patients included. The question of the usefulness of somatostatin analogues in HOS persists, especially as the cost of this treatment is high, and there is a lack of evidence of its effectiveness.
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spelling doaj.art-35489665593e4e13b5cc34297d38d2e32023-09-15T10:12:29ZengTaylor & Francis GroupJournal of Investigative Surgery0894-19391521-05532021-11-0134121312131610.1080/08941939.2020.18008711800871Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment AloneYannis Mesli0Lise Holterbach1Jean-Baptiste Delhorme2Zaher Lakkis3Pablo Ortega-Deballon4Sophie Deguelte5Serge Rohr6Cécile Brigand7Nicolas Meyer8Benoit Romain9Department of Digestive Surgery, Strasbourg University HospitalPôle de Santé Publique - Santé au Travail - Groupe Methode en Recherche Clinique CHRU StrasbourgDepartment of Digestive Surgery, Strasbourg University HospitalDepartment of Digestive Surgery, Besançon University Hospital (Jean Minjoz)Department of Digestive Surgery, Dijon University HospitalDepartment of Digestive Surgery, Reims University HospitalDepartment of Digestive Surgery, Strasbourg University HospitalDepartment of Digestive Surgery, Strasbourg University HospitalPôle de Santé Publique - Santé au Travail - Groupe Methode en Recherche Clinique CHRU StrasbourgDepartment of Digestive Surgery, Strasbourg University HospitalBackground The incidence of high-output stoma (HOS) was reported to be approximately 3 to 16% in the literature, and HOS can cause dehydration. This complication is often severe enough to warrant hospital readmission and may result in renal failure. The aim of this study was to show a decrease of 50% in ileostomy output in the experimental arm using lanreotide treatment. Methods Patients with an ileostomy output ≥ 1.5 l/24 hours were included in this prospective, open, multicentre randomized trial. Patients were randomly allocated between treatment arms with either lanreotide (LAN) and antidiarrhoeal treatments (TAD) (LAN-TAD group) or antidiarrhoeal treatments only (TADS group). The primary outcome was ileostomy output after 72 days. The secondary endpoints were ileostomy output during the first 6 days, blood urea and creatinine values, hospital length of stay and serious adverse events. Results In the per-protocol analysis, there were nine patients in the control group (TADS) and six patients in the experimental group (TAD-LAN group). The stoma outputs at Day 3 (D3) in the experimental and control groups were 1,900 ± 855.7 mL and 1,728.6 ± 845.5 mL, respectively (p = 0.2). No differences were found concerning stoma output at D6, renal function, or hospital length of stay between the two groups. Conclusion The trial was prematurely stopped due to the low number of patients included. The question of the usefulness of somatostatin analogues in HOS persists, especially as the cost of this treatment is high, and there is a lack of evidence of its effectiveness.http://dx.doi.org/10.1080/08941939.2020.1800871somatostatin analogueshigh-output stomadehydrationlanreotide
spellingShingle Yannis Mesli
Lise Holterbach
Jean-Baptiste Delhorme
Zaher Lakkis
Pablo Ortega-Deballon
Sophie Deguelte
Serge Rohr
Cécile Brigand
Nicolas Meyer
Benoit Romain
Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone
Journal of Investigative Surgery
somatostatin analogues
high-output stoma
dehydration
lanreotide
title Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone
title_full Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone
title_fullStr Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone
title_full_unstemmed Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone
title_short Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone
title_sort is lanreotide really useful in high output stoma comparison between lanreotide to conventional antidiarrheal treatment alone
topic somatostatin analogues
high-output stoma
dehydration
lanreotide
url http://dx.doi.org/10.1080/08941939.2020.1800871
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