| CTRI Number |
CTRI/2019/01/016840 [Registered on: 02/01/2019] Trial Registered Prospectively |
| Last Modified On: |
01/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study analyzing the complication rates of keeping the skull bone to its original position at a major neurosurgical centre in South India |
|
Scientific Title of Study
|
Prospective study analyzing the complication rates of cranioplasty at a major neurosurgical centre in South India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandesh O |
| Designation |
Registrar |
| Affiliation |
Kasturba medical college, Manipal.Karnataka |
| Address |
Srirangadarshan Nivasa.
Malligenagara ,Malligenahalli, Sagar road. Shimoga 577201. Karnataka
Registrar
Dept of Neurosurgery
KMC manipal.
Karnataka.
Udupi
KARNATAKA
577201
India |
| Phone |
9964734518 |
| Fax |
|
| Email |
sandeshsrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGirish Menon |
| Designation |
Professor and HOD |
| Affiliation |
Kasturba medical college, Manipal.Karnataka |
| Address |
Dept of Neurosurgery
KMC manipal
Karnataka
Dept of Neurosurgery
KMC manipal
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7760563666 |
| Fax |
|
| Email |
girish.menon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sandesh O |
| Designation |
Registrar |
| Affiliation |
Kasturba medical college, Manipal.Karnataka |
| Address |
Srirangadarshan Nivasa.
Malligenagara ,Malligenahalli, Sagar road. Shimoga 577201. Karnataka
Registrar
Dept of Neurosurgery
KMC manipal.
Karnataka.
Udupi
KARNATAKA
577201
India |
| Phone |
9964734518 |
| Fax |
|
| Email |
sandeshsrd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrSandeshO |
| Address |
Registrar
Dept of Neurosurgery
KMC manipal.
Karnataka. |
| Type of Sponsor |
Private 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 |
| Sandesh O |
Kasturba Medical College , Manipal.Karnataka. |
Dept of Neurosurgery.
Kasturba Medical College , Manipal.Karnataka.
Udupi
KARNATAKA |
9964734518
sandeshsrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Secretariat ,Kasturba Medical College, Manipal , Udupi.Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing cranioplasty procedures in our hospital during the study period |
|
| ExclusionCriteria |
| Details |
Cranioplasties done after tumor removal will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of complications and outcome. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measures to reduce complications |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/01/2019 |
| 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="4"
Days="13" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Prospective study analyzing the complication rates of cranioplasty at a major neurosurgical centre in South India. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Although cranioplasty is a straightforward procedure, it may result in a significant number of complications. These include infections, seizures, intracranial hematomas and others. Many reports have stated that early cranioplasty is associated with higher complications. We intend to share our experience and results on outcomes of cranioplasty from our university hospital. In addition, we intend to propose a few simple steps that would help reduce the complications of these procedures |