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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 

 
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