Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial

Phase 4Not Yet RecruitingNCT07447479

Institute for Clinical Effectiveness, Japan196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

196

Conditions

Idiopathic Normal Pressure Hydrocephalus (INPH)

Interventions

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Change in timed up and go test score

Time frame: 3 months

Secondary Outcomes

Intensive Care Delirium Screening Checklist score

0-8 scale (0 best and 8 worst)

Time frame: 24 hours

10% or greater improvement in the timed up and go score

Time frame: 3 months

Change in timed up and go score

Time frame: 1 month

Change in timed up and go score

Time frame: 6 months

Change in timed up and go score

Time frame: 12 months

Change in average walking speed measured by the 10-meter walk test

Time frame: 3 months

Change in Tinetti scale score

Tinetti scale score is 0-28 scale (28 best and 0 worst)

Time frame: 3 months

Change in modified Rankin Scale score

modified Rankin Scale score 0-6 (0 completely independent and 6 death)

Time frame: 3 months

Change in Overactive Bladder Questionnaire score

Overactive Bladder Questionnaire score has two components of Symptom Bother Scale and HRQoL Scale. Symptom Bother Scale: The 8 items are scored from 1 ("Not at all") to 6 ("A very great deal"). The scores are then summed to produce a total score ranging from 8 to 48, where higher scores indicate greater symptom bother. HRQoL Scale: The 25 items are scored from 1 ("All of the time" / "Extremely") to 6 ("None of the time" / "Not at all"). Importantly, these items are reverse-scored before being summed. The total and subscale scores are then transformed to a 0-100 scale. On this scale, higher scores reflect a better health-related quality of life.

Time frame: 3 month

Change in Mini-Mental State Exam scores

Mini-Mental State Exam scores ranges 0-30 (30 best and 0 worst)

Time frame: 3 months

Change in Montreal Cognitive Assessment--Japanese Version scores

Montreal Cognitive Assessment--Japanese Version scores ranges 0-30 (30 best and 0 worst)

Time frame: 3 months

Change in 5-level EQ-5D version (EQ-5D-5L)

0-1 (0 worst and 1 best quality of life)

Time frame: 3 months

Change in 5-level EuroQoL 5D (VAS)

0-100 (0 worst and 100 best quality of life)

Time frame: 3 months

Days from surgery to discharge

Time frame: 3 months

Days of ambulation after surgery

Time frame: 7 days

Functional Outcomes After LumbOpenitoneal Shunt Placement UndeR Local Anesthesia for Patients With Idiopathic Normal preSsure Hydrocephalus (FLOURISH) Trial

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts