A randomized study of convention decompressive surgery versus novel technique of retaining bone flap by four quadrant technique for traumatic brain injury

Fourâ??quadrant osteoplastic decompressive craniotomy vs Conventional Decompressive craniectomy for Traumatic Brain Injury: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010981

Enrollment

100

Registered

2017-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Head injury patients

Interventions

Intervention1: Four quadrant osteoplastic decompressive craniotomy: Alternative technique to traditional conventional decompressive craniectomy where the bone flap after surgery is cut into 4 pieces a

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with Traumatic Brain injury with surgically evacuable lesions planned for primary decompressive craniectomy and following evacuation of hematoma and lax augmentation duroplasty, brain is persistingly bulging 2) If ICP is persistently >25mmHg for 1-12 hours in patients on ICP monitoring for traumatic brain injury with surgically non-evacuable lesions(secondary decompressive craniectomy)

Exclusion criteria

Exclusion criteria: 1) Refusal by caretakers to become a part of the study 2) Patients requiring mass closure due to unstable clinical condition/malignant cerebral edema 3) Patients with penetrating contaminated wounds

Design outcomes

Primary

Measure	Time frame
A) Functional status at discharge, 3 months and 6 months Functional Status: Glasgow Outcome Scale Extended (GOS-E) will be used to measure functioning level in everyday life. The GOS-E is the most commonly used measure of functional outcome in traumatic brain injury. B) Survival at 3 and 6 months Timepoint: 1) At the time of discharge, 1 month after discharge, 3 months and 6 months after discharge, the GOS-E will be used to assess the primary outcome. 2) The study which was started in January 2017 and ended in July 2017 will assess patients upto 6 months after the discharge date.	—

Measure

Time frame

A) Functional status at discharge, 3 months and 6 months Functional Status: Glasgow Outcome Scale Extended (GOS-E) will be used to measure functioning level in everyday life. The GOS-E is the most commonly used measure of functional outcome in traumatic brain injury. B) Survival at 3 and 6 months Timepoint: 1) At the time of discharge, 1 month after discharge, 3 months and 6 months after discharge, the GOS-E will be used to assess the primary outcome. 2) The study which was started in January 2017 and ended in July 2017 will assess patients upto 6 months after the discharge date.

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Secondary

Measure	Time frame
A) Assessment of rate of complications in each group like post traumatic hydrocephalus, syndrome of the trephined, CSF leak etc B) Radiological outcome- The status of midline shift, status of basal cisterns (present, compressed, effaced), and the presence of uncal herniation etc, IVH, subarachnoid hemorrhage, SDH, and/or EDH will be assessed. In addition, for each CT scan, a Marshall and Rotterdam score was calculated. C) Duration of hospital intervention/ICU stay/ventilator careTimepoint: Assess these complications during in hospital stay and in the post operative period upto the end of follow up. End of follow up is 6 months after discharge.	—

Measure

Time frame

A) Assessment of rate of complications in each group like post traumatic hydrocephalus, syndrome of the trephined, CSF leak etc B) Radiological outcome- The status of midline shift, status of basal cisterns (present, compressed, effaced), and the presence of uncal herniation etc, IVH, subarachnoid hemorrhage, SDH, and/or EDH will be assessed. In addition, for each CT scan, a Marshall and Rotterdam score was calculated. C) Duration of hospital intervention/ICU stay/ventilator careTimepoint: Assess these complications during in hospital stay and in the post operative period upto the end of follow up. End of follow up is 6 months after discharge.

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Countries

India

Contacts

Public ContactSiddharth Vankipuram

King Georges Medical University

neurochandra@gmail.com9742109586

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026