Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial
Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a c...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Scholz, Romy [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2018 |
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| Anmerkung: |
© The Author(s). 2018 |
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| Übergeordnetes Werk: |
Enthalten in: Trials - London : BioMed Central, 2000, 19(2018), 1 vom: 17. Okt. |
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| Übergeordnetes Werk: |
volume:19 ; year:2018 ; number:1 ; day:17 ; month:10 |
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| DOI / URN: |
10.1186/s13063-018-2951-6 |
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SPR030106184 |
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| 245 | 1 | 0 | |a Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial |
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| 520 | |a Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. | ||
| 650 | 4 | |a Idiopathic normal-pressure hydrocephalus |7 (dpeaa)DE-He213 | |
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| 650 | 4 | |a Ventriculoperitoneal shunt |7 (dpeaa)DE-He213 | |
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10.1186/s13063-018-2951-6 doi (DE-627)SPR030106184 (SPR)s13063-018-2951-6-e DE-627 ger DE-627 rakwb eng Scholz, Romy verfasserin aut Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. Idiopathic normal-pressure hydrocephalus (dpeaa)DE-He213 Randomized trial (dpeaa)DE-He213 Dementia (dpeaa)DE-He213 Ventriculoperitoneal shunt (dpeaa)DE-He213 Programmable anti-siphon device (dpeaa)DE-He213 Lemcke, Johannes (orcid)0000-0002-8073-1625 aut Meier, Ullrich aut Stengel, Dirk aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 17. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:17 month:10 https://dx.doi.org/10.1186/s13063-018-2951-6 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 17 10 |
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10.1186/s13063-018-2951-6 doi (DE-627)SPR030106184 (SPR)s13063-018-2951-6-e DE-627 ger DE-627 rakwb eng Scholz, Romy verfasserin aut Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. Idiopathic normal-pressure hydrocephalus (dpeaa)DE-He213 Randomized trial (dpeaa)DE-He213 Dementia (dpeaa)DE-He213 Ventriculoperitoneal shunt (dpeaa)DE-He213 Programmable anti-siphon device (dpeaa)DE-He213 Lemcke, Johannes (orcid)0000-0002-8073-1625 aut Meier, Ullrich aut Stengel, Dirk aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 17. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:17 month:10 https://dx.doi.org/10.1186/s13063-018-2951-6 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 17 10 |
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10.1186/s13063-018-2951-6 doi (DE-627)SPR030106184 (SPR)s13063-018-2951-6-e DE-627 ger DE-627 rakwb eng Scholz, Romy verfasserin aut Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. Idiopathic normal-pressure hydrocephalus (dpeaa)DE-He213 Randomized trial (dpeaa)DE-He213 Dementia (dpeaa)DE-He213 Ventriculoperitoneal shunt (dpeaa)DE-He213 Programmable anti-siphon device (dpeaa)DE-He213 Lemcke, Johannes (orcid)0000-0002-8073-1625 aut Meier, Ullrich aut Stengel, Dirk aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 17. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:17 month:10 https://dx.doi.org/10.1186/s13063-018-2951-6 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 17 10 |
| allfieldsGer |
10.1186/s13063-018-2951-6 doi (DE-627)SPR030106184 (SPR)s13063-018-2951-6-e DE-627 ger DE-627 rakwb eng Scholz, Romy verfasserin aut Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. Idiopathic normal-pressure hydrocephalus (dpeaa)DE-He213 Randomized trial (dpeaa)DE-He213 Dementia (dpeaa)DE-He213 Ventriculoperitoneal shunt (dpeaa)DE-He213 Programmable anti-siphon device (dpeaa)DE-He213 Lemcke, Johannes (orcid)0000-0002-8073-1625 aut Meier, Ullrich aut Stengel, Dirk aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 17. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:17 month:10 https://dx.doi.org/10.1186/s13063-018-2951-6 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 17 10 |
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10.1186/s13063-018-2951-6 doi (DE-627)SPR030106184 (SPR)s13063-018-2951-6-e DE-627 ger DE-627 rakwb eng Scholz, Romy verfasserin aut Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. Idiopathic normal-pressure hydrocephalus (dpeaa)DE-He213 Randomized trial (dpeaa)DE-He213 Dementia (dpeaa)DE-He213 Ventriculoperitoneal shunt (dpeaa)DE-He213 Programmable anti-siphon device (dpeaa)DE-He213 Lemcke, Johannes (orcid)0000-0002-8073-1625 aut Meier, Ullrich aut Stengel, Dirk aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 17. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:17 month:10 https://dx.doi.org/10.1186/s13063-018-2951-6 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 17 10 |
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Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial |
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Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. © The Author(s). 2018 |
| abstractGer |
Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. © The Author(s). 2018 |
| abstract_unstemmed |
Background Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. Methods/design In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. Discussion SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN13838310. Registered on 10 November 2016. © The Author(s). 2018 |
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Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial |
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https://dx.doi.org/10.1186/s13063-018-2951-6 |
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Lemcke, Johannes Meier, Ullrich Stengel, Dirk |
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