- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07583836
DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
연구 개요
상세 설명
Despite the increasing advocacy for early surgery, significant variability persists in clinical practice. This inconsistency stems from conflicting evidence in the literature, with some studies reporting substantial neurological benefits from early intervention, while others find no significant difference compared to delayed surgery. Similarly, in our institute, both early and delayed decompressions are in practice, whichever considered suitable by the experts. But no study has done to date that compare the outcome of both techniques. Given these gaps, there is a pressing need for a comprehensive evaluation of the existing evidence to determine the optimal timing of surgical intervention for acute traumatic SCI especially among our local population where past evidence is scarce. So, this study seeks to contribute to this critical discourse by systematically evaluating the impact of early versus delayed surgical decompression on clinical outcomes in our local population. The study would not only add evidence to the global and local data but would also help the surgeons to choose the better technique in future as the technique with better outcome would be preferred in future among all the local patients who will present to our hospital with acute SCI. Adopting the treatment strategy with better outcome would also help to reduce the overall morbidity associated with a cute SCI in our local population.
Finally objectives are , to compare the outcome of early versus delayed surgical decompression among patients presenting with traumatic spinal cord injury in a tertiary care hospital.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Dr. Salman Tahir, MBBS
- 전화번호: +92 322 6192355
- 이메일: ffh.rawalpindi@fauji.org.pk
연구 장소
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Rawalpindi, 파키스탄
- 모병
- Fauji Foundation Hospital, Rawalpindi
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연락하다:
- Salman Dr, MBBS
- 전화번호: +92 322 6192355
- 이메일: xalmantahir@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients presenting with spinal cord injury (both cervical and thoracic) as per described in the operational definition
- Age from 18-60 years
- Both male and female patients
Exclusion Criteria:
- Patients with penetrating spinal injuries such as gunshot/stab wounds
- Patients with pre-existing neurological conditions like myelopathy etc.
- Patients with any kind of malignancy
- Patients having CSF infection etc.
- Patients who are not fit for general anesthesia (i.e. ASA Grade >2 Annexure-B)
- Diagnosis of subclinical or clinical polyneuropathy
- Non-traumatic or pathological fractures or cord compression
- Inability to cooperate with preoperative physical examination because of cognitive impairment
- Patients with previous spinal column or SCI.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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improvement in neurological impairment using ASIA Impairment Scale (AIS)
기간: 12 Weeks after surgery
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Treatment outcomes will be measured 12 weeks after early or delayed surgical decompression among all the patients who underwent spinal cord injury in terms of improvement in neurological impairment using ASIA Impairment Scale (AIS) attached as annexure-C.
Outcome will be labelled as good if shows improvement for at least two AIS grades.
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12 Weeks after surgery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
키워드
기타 연구 ID 번호
- 999/RC/FFH/RWP
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