| CTRI Number |
CTRI/2025/07/090269 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Types of Brain Surgery for Sudden Bleeding Inside the Brain – A Forward-Looking Study |
|
Scientific Title of Study
|
Surgical Management of Spontaneous Intracerebral Hemorrhage-Endoscopic Versus Open Surgery- A Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Awdhesh Kumar Yadav |
| Designation |
Guide |
| Affiliation |
King Georges Medical University |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), room number 504, 5th floor, shatabdi hospital, phase 2 Chowk, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9919282888 |
| Fax |
|
| Email |
awkymail@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Awdhesh Kumar Yadav |
| Designation |
Guide |
| Affiliation |
King Georges Medical University |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), room number 504, 5th floor, shatabdi hospital, phase 2 Chowk, Lucknow, Uttar Pradesh.
UTTAR PRADESH
226003
India |
| Phone |
9919282888 |
| Fax |
|
| Email |
awkymail@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Awdhesh Kumar Yadav |
| Designation |
Guide |
| Affiliation |
King Georges Medical University |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), room number 504, 5th floor, shatabdi hospital, phase 2 Chowk, Lucknow, Uttar Pradesh.
UTTAR PRADESH
226003
India |
| Phone |
9919282888 |
| Fax |
|
| Email |
awkymail@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), room number 504, 5th floor, shatabdi hospital, phase 2 Chowk, Lucknow, Uttar Pradesh. |
|
|
Primary Sponsor
|
| Name |
Dr Sahil Garg |
| Address |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), room number 504, 5th floor, shatabdi hospital, phase 2 Chowk, Lucknow, Uttar Pradesh. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sahil Garg |
King George medical university Department of Neurosurgery |
King George Medical University, (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chowk, Lucknow, Uttar Pradesh.
Lucknow
UTTAR PRADESH |
9988539034
gargsahil2108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neuroendoscopic Hematoma Evacuation |
The intervention involved neuroendoscopic hematoma evacuation, a minimally invasive surgical technique performed under general anesthesia. A small burr hole was made at a predetermined site based on hematoma location, through which a rigid neuroendoscope was introduced into the hematoma cavity. Continuous irrigation and suction were used to evacuate the clot under direct endoscopic visualization. Hemostasis was achieved using bipolar cautery or tamponade as needed. This technique aims to reduce brain tissue trauma, operative time, and postoperative complications compared to conventional craniotomy. |
| Comparator Agent |
Open Craniotomy and Hematoma Evacuation |
open craniotomy with hematoma evacuation, a conventional surgical technique involving the creation of a bone flap to access the hematoma site. Under general anesthesia, the intracerebral clot was evacuated under direct vision using standard neurosurgical instruments. Hemostasis was ensured, and the bone flap was replaced following clot removal. This method represents the current standard approach for surgical management of spontaneous intracerebral hemorrhage. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients eligible for inclusion in the study were those diagnosed with spontaneous supratentorial intracerebral hemorrhage (ICH), confirmed through either computed tomography (CT) or magnetic resonance imaging (MRI) of the head. Inclusion criteria required a hematoma volume greater than 30 milliliters and the presence of a midline shift measuring 6 millimeters or more. Additionally, patients needed to have a Glasgow Coma Scale (GCS) score of 5 or higher to qualify. Both male and female patients between the ages of 18 and 75 years were considered for the study.
|
|
| ExclusionCriteria |
| Details |
Patients were excluded from the study if the intracerebral hemorrhage (ICH) was secondary to underlying conditions such as tumors, aneurysms, post-infarction hemorrhage, or vascular malformations. Additional exclusion criteria included a history of trauma or head injury, the presence of coagulation disorders, or the occurrence of multiple intracranial hematomas. Major systemic comorbidities affecting life expectancy (e.g., heart, kidney, liver, lung diseases).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study was the hematoma evacuation rate calculated using the formula preoperative hematoma volume postoperative volume / preoperative volume × 100, based on CT imaging performed after surgery. This parameter was used to compare the surgical efficacy between the neuroendoscopy and open craniotomy groups. |
CT head were obtained on the post operative days 0 and 5 and at the time of discharge. Radiological data was compared with the preoperative scan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes included postoperative Glasgow Coma Scale (GCS) at day 5 and at discharge, duration of ICU and hospital stay, incidence of rebleeding, residual hematoma, need for re-exploration surgery, postoperative complications (e.g., CSF leak, surgical site infection, meningitis, systemic infections), and mortality during hospital stay, along with functional outcome assessed at 3 months using the Extended Glasgow Outcome Scale (GOSE). |
three months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/07/2025 |
| 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
|
This study aimed to evaluate and compare the clinical outcomes of two suturing techniques—short stitch versus conventional stitch—for midline rectus sheath closure in patients undergoing emergency laparotomy. Conducted as a randomized comparative trial, the study enrolled 42 patients equally divided into two groups. The short stitch technique involved smaller tissue bites placed at shorter intervals, while the conventional technique followed standard wider spacing. The primary outcomes measured were postoperative complications, including wound dehiscence, surgical site infections (SSIs), and the development of incisional hernia over a 6-month follow-up period. The results demonstrated a clear advantage of the short stitch technique. Patients in this group experienced significantly fewer complications: SSIs occurred in only 9.5% compared to 38.1% in the conventional group, while wound dehiscence and incisional hernia rates were also notably lower (4.8% vs 33.3% and 4.8% vs 19.0%, respectively). These findings indicate that the short stitch method provides better wound integrity, lowers the risk of infection and hernia, and overall improves patient outcomes. The study concludes that the short stitch technique is a safer and more effective alternative for midline abdominal closure in emergency settings. |