Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele (PSEUDO)
Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial
Dear Sir or Madam,
You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). CSF pseudomeningocele is a complication that may occur after brain surgery and is characterized by an accumulation of cerebrospinal fluid beneath the skin. At present, there is no clear consensus regarding the optimal treatment approach.
How the study will be conducted
After enrollment in the study, you will be randomly assigned (by chance) to one of two groups:
Conservative management: no surgical intervention, regular follow-up, and wound care.
Interventional treatment: simple aspiration/puncture, insertion of a lumbar drain, or reoperation.
During the study, you will be followed for a period of 1 year. Follow-up examinations will include clinical assessment and brain imaging (CT or MRI) at 4 months and 12 months after enrollment.
Risks associated with the interventional group Simple cyst aspiration/puncture: infection, bleeding into the pseudomeningocele.
Lumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches.
Reoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study
12 months
Expected total number of participants enrolled in the study
20 participants
Benefit of the study
The aim of the study is to compare the effect of surgical intervention with conservative management.
Compensation for participation
Participation in this study is not associated with any financial compensation.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Norbert Svoboda, MD, PhD, FEBNS
- 전화번호: ++420973202932
- 이메일: norbert.svoboda@uvn.cz
연구 장소
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Prague
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Prague, Prague, 체코, 16000
- 모병
- Military University Hospital Prague
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연락하다:
- Norbert Svoboda, MD, PhD, FEBNS
- 전화번호: ++420973202932
- 이메일: norbert.svoboda@uvn.cz
-
연락하다:
- Martin Majovsky, MD, Ass. Prof., PhD, FEBNS
- 전화번호: +420973202963
- 이메일: martin.majovsky@uvn.cz
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pseudomeningocele after elective intracranial surgery
- Willing and able to give informed consent
- No prior cranial or spinal surgical intervention
- Pseudomeningocele Palpation Scale (PPS) II-IV, no severe pain of the PMC (VAS 7-10) - Tension MK
Exclusion Criteria:
- PMC following emergency or trauma surgery
- Known or suspected infection at the PMC site at recruitment
- Severe comorbidities preventing participation (e.g. terminal illness, organ failure)
- Conditions requiring urgent unrelated surgical intervention
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Conservative
Patients managed without surgical procedures, except for skin sutures.
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실험적: Interventional
Patients undergoing local treatment - lumbar drainage insertion, simple wound puncture, fibrin glue or any combination.
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Insertion of Lumbar drain
aspiration of the CSF fluid with injection
after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele
Revision surgery in order to prevent future pseudomeninogocele formation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CSF Leakage or Tension pseudomeningocoele
기간: 12 months
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New-onset wound CSF leakage requiring revision surgery, or pseudomeningocele associated with severe headaches not responsive to analgesics.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Infection
기간: 12 months
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To compare the infection rate between the two treatment groups.
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12 months
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Glasgow Outcome Scale Extended (GOSE)
기간: 12 months
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To assess functional recovery using the Glasgow Outcome Scale-Extended (GOSE) at 1 year post-surgery.
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12 months
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Absorption of the Pseudomeningocoele
기간: 12 months
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Absorption of pseudomendingocoele at 4 months and 1 year post-surgery assessed by CT or MRI
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12 months
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Pain
기간: 12 months
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Persistence of headache after the surgery - Pain Scale 0-10 (VAS)
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12 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 108/20-55/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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