Randomized clinical trial of sacral nerve stimulation for refractory constipation

Autor: F Zerbib, L Siproudhis, P-A Lehur, C Germain, F Mion, A-M Leroi, B Coffin, A Le Sidaner, V Vitton, C Bouyssou-Cellier, G Chene, M Simon, Q Denost, P Lepicard, G Meurette, V Wyart, C Kubis, S Roman, H Damon, X Barth, V Bridoux, G Gourcerol, B Castel, C Gorbatchef, Anne Le Sidaner, M Mathonnet, N Lesavre, P Orsoni, C Brochard, V Desfourneaux
Přispěvatelé: CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Rouen, Normandie Université (NU), Université Paris Diderot - Paris 7 (UPD7), CHU Limoges, Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), This study was funded by a grant from the French Ministry of Health (PHRC 2011) and promoted by Bordeaux University Hospital (Délégation à la Recherche Clinique, Centre Hospitalier Universitaire de Bordeaux)., CHU Bordeaux [Bordeaux], CHU Rennes - Service gastroentérologie, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d'Investigation Clinique - Epidemiologie Clinique / Essais Cliniques Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL), Service de physiologie digestive, urinaire, respiratoire et de l'exercice [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Hôpital Charles Nicolle [Rouen], Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), CHU Marseille, Enjalbert, Alain, Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
Rok vydání: 2016
Předmět:
Adult
Male
medicine.medical_specialty
Constipation
Adolescent
[SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology
Lumbosacral Plexus
Electric Stimulation Therapy
Stimulation
law.invention
Young Adult
03 medical and health sciences
0302 clinical medicine
Hematoma
Double-Blind Method
Randomized controlled trial
Refractory
law
medicine
Humans
ComputingMilieux_MISCELLANEOUS
Aged
Cross-Over Studies
business.industry
[SDV.NEU.NB] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology
[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
Middle Aged
medicine.disease
Crossover study
[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology
Surgery
Lumbosacral plexus
Implantable Neurostimulators
Treatment Outcome
030220 oncology & carcinogenesis
Anesthesia
Defecation
Female
030211 gastroenterology & hepatology
medicine.symptom
business
Follow-Up Studies
Zdroj: British Journal of Surgery
British Journal of Surgery, 2017, 104 (3), pp.205-213. ⟨10.1002/bjs.10326⟩
British Journal of Surgery, Wiley, 2017, 104 (3), pp.205-213. ⟨10.1002/bjs.10326⟩
ISSN: 1365-2168
0007-1323
DOI: 10.1002/bjs.10326
Popis: Background Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT. Methods Patients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year. Results Thirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time. Conclusion These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).
Databáze: OpenAIRE
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