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CTRI Number  CTRI/2024/05/067764 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 19/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Difficulties and complications of lumbar drain 
Scientific Title of Study   Lumbar drain in transnasal endoscopic neurosurgery cases: technical difficulties and complications- an observational 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  Dr Senthil Kumar TS 
Designation  Senior Consultant Department of Anaesthesiology 
Affiliation  SIMS Hospital 
Address  SIMS Hospital, Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026

Chennai
TAMIL NADU
600026
India 
Phone  9444191218  
Fax    
Email  drsenthilkumarts@protonmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Senthil Kumar TS 
Designation  Senior Consultant Department of Anaesthesiology 
Affiliation  SIMS Hospital 
Address  SIMS Hospital Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026

Chennai
TAMIL NADU
600026
India 
Phone  9444191218  
Fax    
Email  drsenthilkumarts@protonmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Senthil Kumar TS 
Designation  Senior Consultant Department of Anaesthesiology 
Affiliation  SIMS Hospital 
Address  SIMS Hospital Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026

Chennai
TAMIL NADU
600026
India 
Phone  9444191218  
Fax    
Email  drsenthilkumarts@protonmail.com  
 
Source of Monetary or Material Support  
SIMS hospitals - institute of neuroscience  
 
Primary Sponsor  
Name  SIMS Hospitals 
Address  Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Senthil Kumar TS  SIMS Hospital  Metro No.1 Jawaharlal Nehru Road, Landmark:, next to Vadapalani, Chennai, Tamil Nadu 600026
Chennai
TAMIL NADU 		 944419218

drsenthilkumarts@protonmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SIMS Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lumbar drain  Insertion of lumbar drain under sterile aseptic precautions after general anaesthesia and studying difficulties  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All neurosurgery patients scheduled for elective transnasal transsphenoidal resection of stellar, suprasellar lesions requiring lumbar drain, all neurosurgery patients scheduled for elective transnasal CSF rhinorrhea repair requiring lumbar drain, ASA 1, 2 and 3 patients  
 
ExclusionCriteria 
Details  Patients unwilling to participate in study, ASA 4 and 5, patients with history of bleeding diagnosis, patients with infection at the site of drain insertion, patients having systemic sepsis, patients who have undergone previous spine operations, per existing neurological or demyelinating lesions  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence of complications associated with preoperative lumbar drain placement in endoscopic pituitary surgery
To study the incidences of difficulties observed with lumbar CSF drain catheter placement 		 From insertion of lumbar drain to removal  
 
Secondary Outcome  
Outcome  TimePoints 
To study the difficulties observed with lumbar CSF drain catheter placement  Before, during & after surgery  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/06/2024 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsenthilkumarts@protonmail.com].

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 13-04-2060?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   All patients who satisfy the inclusion  and exclusion criteria will be monitored for technical difficulties and complications of the lumbar drain which will be performed under general anaesthesia and observations recorded and reported 

 
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