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IRCT20230907059376N4 IRCT 2024-02-14 Khyber Teaching Hospital, Peshawar Importance of timing in craniotomy in Spontaneous intracereberal haemorrhage: experience in tertiary care hospital Importance of timing in craniotomy in Spontaneous intracereberal haemorrhage 2022-01-21 anticipated 70 Complete https://irct.ir/trial/75460 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we implemented randomization to ensure unbiased allocation of participants to treatment groups. We employed block randomization, grouping participants based on specific criteria, and then randomly assigning them to treatment groups within each block. This method helps maintain balance across treatment groups and controls for potential confounding variables. Randomization was carried out at the individual level, ensuring each participant had an equal chance of being assigned to any treatment group, Blinding description: Outcome assessors were blinded to treatment assignments through the utilization of sealed envelopes containing group allocations, ensuring impartial evaluation of study outcomes. N/A Intracranial Haemorrhage. Intervention 1: Control group: This approach involved providing standard medical care without immediate surgical intervention. Specifically, patients received routine medical attention aimed at stabilizing their condition and managing symptoms. This included pharmacological interventions such as medications to control blood pressure, pain management, and other supportive measures. However, crucially, these patients did not undergo surgical procedures such as craniotomy for hematoma evacuation.Additionally, patients in the medical management group did not undergo continuous monitoring of vital signs and neurological status, nor was there a predefined cutoff point for initiating surgical intervention based on changes in these parameters. Instead, they were managed conservatively with medical therapy alone, with interventions for complications initiated as clinically indicated rather than preemptively. Intervention 2: Intervention group: Patients assigned to the early surgical intervention group received a more aggressive treatment approach involving prompt surgical intervention within 24 hours of symptom onset. This involved performing a craniotomy procedure aimed at evacuating the hematoma and achieving control of the bleeding source. The surgical intervention was conducted promptly to minimize the potential deleterious effects of the hematoma, such as increased intracranial pressure and compression of vital brain structures.Unlike the medical management group, patients in the early surgical intervention group underwent surgical procedures aimed at directly addressing the underlying pathology causing their symptoms. This proactive approach aimed to expedite hematoma evacuation and prevent further neurological deterioration associated with delayed surgical intervention.Following the surgical procedure, patients in both groups were regularly monitored and followed up with imaging studies to assess the efficacy of the treatment approach. This allowed clinicians to evaluate the resolution of the hematoma, assess for any complications related to the intervention, and track the overall clinical progress of the patients over time. Yes - There is a plan to make this available What will be shared: Data will be provided under the title importance of timing in craniotomy in Spontaneous intracereberal haemorrhage: experience in a Tertiary care hospital When: Data will be available after approval of RCT To whom: Data will be available to neurosurgeons and medical students Conditions: Data will be used after approvla from principle author Where to obtain: Data will be obtained through email to principle author Muhammad Idris Khan idrisnsw83@gmail.com How to obtain: Process is simple. Just the seeker have to email the author Comments:
public Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar scientific Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar Pakistan Patients age range from 18 to 70 years Patients of both genders, i.e. male and female Patients who were diagnosed with spontaneous ICH and confirmed by neuroimaging to have a Glasgow Coma Scale (GCS) score of 5-18 18 years 70 years Both Patients who have traumatic intracerebral bleeding All the cases requiring surgical intervention Deep-seated bleeding, coagulopathy, pregnancy, or pre-existing neurological conditions that could affect results were excluded from this study. I62.9 Nontraumatic intracranial hemorrhage, unspecified Treatment - Drugs Treatment - Surgery Control group: This approach involved providing standard medical care without immediate surgical intervention. Specifically, patients received routine medical attention aimed at stabilizing their condition and managing symptoms. This included pharmacological interventions such as medications to control blood pressure, pain management, and other supportive measures. However, crucially, these patients did not undergo surgical procedures such as craniotomy for hematoma evacuation.Additionally, patients in the medical management group did not undergo continuous monitoring of vital signs and neurological status, nor was there a predefined cutoff point for initiating surgical intervention based on changes in these parameters. Instead, they were managed conservatively with medical therapy alone, with interventions for complications initiated as clinically indicated rather than preemptively. Intervention group: Patients assigned to the early surgical intervention group received a more aggressive treatment approach involving prompt surgical intervention within 24 hours of symptom onset. This involved performing a craniotomy procedure aimed at evacuating the hematoma and achieving control of the bleeding source. The surgical intervention was conducted promptly to minimize the potential deleterious effects of the hematoma, such as increased intracranial pressure and compression of vital brain structures.Unlike the medical management group, patients in the early surgical intervention group underwent surgical procedures aimed at directly addressing the underlying pathology causing their symptoms. This proactive approach aimed to expedite hematoma evacuation and prevent further neurological deterioration associated with delayed surgical intervention.Following the surgical procedure, patients in both groups were regularly monitored and followed up with imaging studies to assess the efficacy of the treatment approach. This allowed clinicians to evaluate the resolution of the hematoma, assess for any complications related to the intervention, and track the overall clinical progress of the patients over time. Functional Independance measure. Timepoint: The measurement was taken at baseline and after 90 days. Method of measurement: A modified Ranken scale was used to assess the functional independance measure. Khyber Teaching Hospital, Peshawar Approved 2022-01-12 Ethical committe of khyber teaching hospital University Rd, Rahat Abad, Peshawar, Khyber Pakhtunkhwa, Pakistan Peshawar Khyber Pakhtunkhwa Pakistan