Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial
Megadott ok: Before the enrolment of participants, the principal investigator was fired, and the study site did not allow the continuation of the study.
A legfontosabb adatok
- Fázis
- 4. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- Institute for Clinical Effectiveness, Japan
- Azonosító
- NCT07447479
- A regiszteradat frissítve
- 2026. augusztus 21.
- Eredeti leírás
This study is a prospective observational registry study that enrolls all patients aged 60 years or older suspected of having idiopathic normal pressure hydrocephalus based on the Third Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. From the cohort registered, patients judged to be candidates for surgery based on the 3rd Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. These patients will be randomized 1:1 to undergo either ventriculoperitoneal shunt surgery under general anesthesia or lumbar peritoneal shunt surgery under local anesthesia. A randomized clinical trial would attest the non-inferiority of lumbar peritoneal shunt surgery under local anesthesia compared to ventriculoperitoneal shunt surgery under general anesthesia regarding the improvement in timed up-and-go test scores at 3 months post-surgery relative to pre-surgery levels.A teljes eredeti leírásKevesebb
Functional Outcomes After Lumbopenitoneal Shunt Placement Under Local Anesthesia for Patients With Idiopathic Normal Pressure Hydrocephalus Trial
This study is a prospective observational registry study that enrolls all patients aged 60 years or older suspected of having idiopathic normal pressure hydrocephalus based on the Third Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. From the cohort registered, patients judged to be candidates for surgery based on the 3rd Edition of the Guidelines for the Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. These patients will be randomized 1:1 to undergo either ventriculoperitoneal shunt surgery under general anesthesia or lumbar peritoneal shunt surgery under local anesthesia. A randomized clinical trial would attest the non-inferiority of lumbar peritoneal shunt surgery under local anesthesia compared to ventriculoperitoneal shunt surgery under general anesthesia regarding the improvement in timed up-and-go test scores at 3 months post-surgery relative to pre-surgery levels.
Bevonási feltételek: Probable iNPH patients; Age 60 years or older at the time of the tap test; Patients capable of performing the Timed Up and Go test; Patients assignable within 2 weeks (14 days) of obtaining RCT consent; Patients capable of undergoing shunt surgery within 1 month (30 days) of assignment; Patients capable of follow-up at the assigned facility or referring facility for 12 months after assignment; Patients for whom informed consent was obtained.
Kizáró feltételek: Patients deemed unsuitable for lumbar-abdominal shunt surgery due to advanced degeneration of the lumbar spine and spinal canal, etc; Patients deemed unsuitable for abdominal shunt surgery due to a history of multiple open abdominal surgeries, a history of severe intra-abdominal infection, etc; Other patients deemed unsuitable by the attending physician.