A study comparing the effectiveness of single burr hole of the skull with double burr hole of the skull in the management of chronic subdural haemorrhage
| ISRCTN | ISRCTN53688663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53688663 |
- Submission date
- 21/04/2025
- Registration date
- 24/04/2025
- Last edited
- 24/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study aims to evaluate the effectiveness of single burr hole as compared to double burr hole craniostomy for chronic subdural hematoma (cSDH), an old clot of blood on the surface of the brain beneath its outer covering. The objectives are to determine the outcomes, risks and benefits of single burr hole as compared to double burr hole in cSDH patients, and to evaluate illness, death and complications in cSDH patients.
Who can participate?
Patients aged 18 years and over with chronic subdural haematoma
What does the study involve?
Participants were randomly allocated to undergo either single burr hole craniostomy or double burr hole craniostomy. Participants were monitored through follow-ups at 1 week and 1 month after surgery. The follow-up assessments were designed to evaluate the effectiveness of the surgeries, monitor recovery, and detect any complications or differences in success rates between the two methods.
What are the possible benefits and risks of participating?
There are no additional risks from the procedure as such. The study will help contribute to the standardisation of treatment as single burr hole craniostomy is a simple, less time-consuming and less invasive treatment.
Where is the study run from?
All India Institute of Medical Sciences, Patna
When is the study starting and how long is it expected to run for?
June 2022 to September 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Deepak Kumar, deepaky447@gmail.com, id-deepak10890@aiimspatna.org
Contact information
Public, Scientific, Principal Investigator
Trauma office first floor
AIIMS Patna Trauma Center
AIIMS Patna, AIIMS Road
Phulwarisharif
Patna
801507
India
 ORCID ID |
0009-0003-9733-0101 |
|---|---|
| Phone | +91 (0)7991190620 |
| id-deepak10890@aiimspatna.org |
Study information
| Study design | Open randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A randomized controlled trial comparing the efficacy of single burr hole with double burr hole in the patients of chronic subdural hematoma |
| Study acronym | SDCSDH |
| Study objectives | Single burr hole craniostomy is equally effective as double burr hole craniostomy and introduces lesser risk in treatment of chronic subdural hematoma (cSDH). |
| Ethics approval(s) |
Approved 21/06/2022, AIIMS Patna Ethical Committee (Division of Research, All India Institute of Medical Sciences, Patna, AIIMS Road, Patna, 801507, India; +91 (0)612 2451006; researchdivision@aiimspatna.org), ref: AIIMS/Pat/IEC/PGth/Jul22/16 |
| Health condition(s) or problem(s) studied | Chronic subdural hematoma |
| Intervention | Participants were randomised by simple randomisation into two groups: Group A: Double burr hole (frontal and parietal) Group B: Single burr hole (parietal) Radiological assessment (NCCT BRAIN) was done preoperatively, postoperatively at 6 hours and at the time of discharge. Patients were followed up at 1 week and 1 month post-discharge. Follow-up questionnaires (persistent headache, focal neurological deficit, seizure and altered level of consciousness) were filled in the master chart and evaluated further. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Post-operative complications assessed at 6 hours, 1 week and 1 month post-intervention 2. Surgical site infection assessed using CDC criteria at 6 hours, 1 week and 1 month post-intervention 3. Persistence of headache assessed using the Headache Impact Test (HIT-6) at 1 month 4. Neurological deficit assessed using the Glasgow Coma Scale (GCS) at 1 month 5. Level of consciousness assessed using the Glasgow Coma Scale (GCS) at 1 month |
| Secondary outcome measures | 1. ICU length of stay measured using patients' medical records 2. Hospital length of stay measured using patients' medical records |
| Overall study start date | 21/06/2022 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 66 |
| Total final enrolment | 66 |
| Key inclusion criteria | All diagnosed cases of chronic subdural hematoma |
| Key exclusion criteria | 1. Patients with recurrent chronic subdural hematoma (cSDH) 2. Patients with asymptomatic chronic subdural hematoma (cSDH) 3. Patients with hematological disorders or those using anticoagulant drugs 4. Patients with septated membranes in chronic subdural hematoma (cSDH) 5. Patients with acute on chronic subdural hematoma (SDH) |
| Date of first enrolment | 01/07/2023 |
| Date of final enrolment | 01/07/2024 |
Locations
Countries of recruitment
- India
Study participating centre
AIIMS Patna, AIIMS Road, Phulwari Sharif
Patna
801507
India
Sponsor information
University/education
AIIMS Patna Trauma Center
AIIMS Road, Phulwarisharif
Patna
801507
India
| Phone | +91 (0)612-2451006 |
|---|---|
| admin@aiimspatna.org | |
| Website | https://aiimspatna.edu.in/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 05/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Plan to publish in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 23/04/2025 | No | No |
Additional files
Editorial Notes
22/04/2025: Study's existence confirmed by AIIMS Patna Ethical Committee.
