- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07583836
DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
COMPARISON OF DELAYED VERSUS EARLY SURGICAL DECOMPRESSION FOR TRAUMATIC SPINAL CORD INJURY
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Dr. Salman Tahir, MBBS
- Telefonnummer: +92 322 6192355
- E-Mail: ffh.rawalpindi@fauji.org.pk
Studienorte
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Rawalpindi, Pakistan
- Rekrutierung
- Fauji Foundation Hospital, Rawalpindi
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Kontakt:
- Salman Dr, MBBS
- Telefonnummer: +92 322 6192355
- E-Mail: xalmantahir@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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improvement in neurological impairment using ASIA Impairment Scale (AIS)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 999/RC/FFH/RWP
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