| CTRI Number |
CTRI/2025/07/090834 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Subdural bleed operation |
|
Scientific Title of Study
|
CT Imaging features of Chronic subdural hematoma: Correlation with preoperative clinical findings and postoperative outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anoop Kumar Singh |
| Designation |
Head of the Department, Neurosurgery |
| Affiliation |
Lifeline Hospital and Research Centre Azamgarh |
| Address |
Neurosurgery department, First floor, Room number 1, Lifeline Hospital and Research Centre, 496, Madaya, Azamgarh, UP, -276001 496, Madaya, Azamgarh, UP, -276001 Azamgarh UTTAR PRADESH 276001 India |
| Phone |
09415243070 |
| Fax |
|
| Email |
anoop.yd@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anoop Kumar Singh |
| Designation |
Head of the Department, Neurosurgery |
| Affiliation |
Lifeline Hospital and Research Centre Azamgarh |
| Address |
Neurosurgery department, First floor, ROOM NUMBER 1,
Lifeline Hospital & Research Centre, 496, Madaya, Azamgarh, UP, -276001 496, Madaya, Azamgarh, UP, -276001 Azamgarh UTTAR PRADESH 276001 India |
| Phone |
09415243070 |
| Fax |
|
| Email |
anoop.yd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vikas Verma |
| Designation |
SR-I Neurosurgery |
| Affiliation |
Lifeline Hospital and Research Centre Azamgarh |
| Address |
Neurosurgery department, Room number 6, Lifeline Hospital & Research Centre, 496, Madaya, Azamgarh, UP, -276001 496, Madaya, Azamgarh, UP, -276001 Azamgarh UTTAR PRADESH 276001 India |
| Phone |
9161647777 |
| Fax |
|
| Email |
verma2025vikas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Line Hospital and Research Centre, 496, Madya, Azamgarh, UP |
|
|
Primary Sponsor
|
| Name |
Lifeline Hospital and Research Centre |
| Address |
496, Madaya, Azamgarh, UP |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anoop Kumar Singh |
Life Line Hospital and Reserach Centre |
OT1 and OT2
Department of Neurosurgery Azamgarh UTTAR PRADESH |
09415243070
anoop.yd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Life Line Hospital Ajamgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microscopic chronic subdural hematoma evacuation |
After general anesthesia, the patient will be positioned with the affected side up and parallel to the roof. Two linear skin incisions, each measuring two centimeters, will be placed, one on the frontal and the other on the parietal area. All scalp layers will be cut, retracted, and burr hole will be made at each site. The dura will be cauterized and incised, and the underlying subdural bleed will be evacuated.
At this stage microscope will be used and will be focussed at the surgical bed through the burr holes to explore the presence of any additional membranes. If the underlying brain is visible, the cavity will be irrigated, and closure will be followed. If not, the surgical floor will be explored further through the microscope for the presence of additional membranes until a normal brain surface is reached.
All these subcompartments will be connected through the fenestrations, and encysted cavities will be thoroughly irrigated to evacuate entrapped subdural bleeding. Finally, with the exposure of the normal brain and hemostasis, closure will follow.
The presence and number of additional membranes will be documented and compared with the preoperative imaging. The patient will be followed in the postoperative period for any complications and with serial scans for the recurrence.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
CT/MRI confirmed chronic subdural hematoma (CSDH) patient
Age more than 18 years
Operated with double burr hole drainage technique
|
|
| ExclusionCriteria |
| Details |
1. Cases with incomplete medical records or imaging data.
2. CSDH operated with other than burr hole drainage technique.
3. Patients who are not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of membranes identified till the visibility of normal brain
2. Fenestration of all membranes
3. completeness in the evacuation of chronic subdural hematoma |
from the incision till the closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Complications like pneumocephalus, bleeding |
24 hours after surgery |
| Reduction in hospital stay |
Recovery and discharge |
| Reduction in recurrence |
One month |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brief statement of the study hypothesis Chronic subdural hematoma (SDH) is a blood collection in the subdural space that is more than 3 weeks old. Chronic subdural hematoma (CSDH) is a common neurosurgical condition, particularly affecting the elderly population. Despite being a well-recognized entity, CSDH presents several challenges in terms of management and outcome prediction. The diagnosis is based on clinical symptoms and radiological investigation, mostly non-contrast CT scans. Computed Tomography (CT) imaging has become indispensable in diagnosing and managing CSDH. It provides critical information about the hematoma’s characteristics, including its size, density, and mass effect on surrounding brain structures. MRI brain scans have added advantages, providing information about the chronicity of the hematoma and the presence or absence of additional membranes. TREATMENT Conservative: Bed Rest, Osmotic Diuresis, Corticosteroids Surgery: Craniotomy/burr hole (Single and double burr hole) drainage and Twist drill craniostomy Endovascular intervention: Middle meningeal artery embolization Worldwide double burr hole craniostomy is the most commonly performed surgical procedure for a chronic subdural hematoma. With the advantages of being the most straightforward neurosurgical procedure that can be performed even in the most resource-constrained settings, using the least instruments, the procedure is known for its inherent complications, the most notable among them being recurrence. The most common reason for these recurrences is the presence of additional membranes, resulting in a multicompartmental chronic subdural hematoma (SDH) in affected patients. Missing any of these membranes will increase the chances of recurrence. Identification and proper surgical management of these membranes are crucial to avoid recurrences. Membrane identification According to the prevailing literature, an MRI brain scan is more sensitive than a CT scan in delineating these membranes preoperatively, thereby helping to avoid recurrences. However, since CT scan heads are the investigation of choice in emergencies, surgery in most CSDH patients is performed solely based on the CT, further increasing the chances of recurrence. Hence, the author explores the preoperative CT and MRI brain findings in patients with CSDH, under the supervision of an experienced radiologist with more than five years of experience, to identify additional membranes and further correlate these findings during surgery to improve surgical outcomes. Surgical aspects Furthermore, in the surgical portfolio, the use of endoscopes in this surgery is again being touted as a means to avoid these recurrence risks. However, using a microscope as the sole surgical equipment in this surgery has never been considered to identify the membranes and fenestrate them, thereby increasing cure rates. Contrary to the fact that neurosurgeons remain more familiar with microscopes than endoscopes, it could probably be the only neurosurgical procedure where endoscope use is claimed to be superior, and the use of microscopes had never been considered. One reason could be a small burr hole is the only opening to enter inside the skull, and given apparent reason, entry and vision of a microscope may be considered less effective than endoscopic vision. However, in the author’s view, as an experienced microscopic neurosurgeon, this can’t be a limitation, as he can easily see the surgical floor even with a 12mm burr hole and, if required, can perform his work efficiently of membrane fenestration through a seemingly small bur hole opening. Worldwide, especially in developing countries, the availability of CT scans is often better than that of MRIs in many places, and most neurosurgeons remain more comfortable with microscopes than endoscopes. The primary purpose of the protocol This study aimed to confirm the hypothesis that we can achieve a similar cure rate in terms of recurrence avoidance using our more universally available CT head and microscope modalities compared to an endoscope in CSDH patients. This will be a real help for our patients in middle and low-socioeconomic countries. |