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CTRI Number  CTRI/2011/06/001793 [Registered on: 09/06/2011] Trial Registered Prospectively
Last Modified On: 21/02/2013
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Changes in parameters of respiratory system during laparoscopic repair of inguinal hernia . A preliminary study.  
Scientific Title of Study   Changes in respiratory mechanics during extraperitoneal insufflation in inguinal hernia surgery. A preliminary study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EC/04/11/242  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram Hospital New Delhi 
Address  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar

New Delhi
DELHI
110060
India 
Phone  01142252513  
Fax  01142252513  
Email  nitinsethi77@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram Hospital New Delhi 
Address  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar

New Delhi
DELHI
110060
India 
Phone  01142252513  
Fax  01142252513  
Email  nitinsethi77@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nitin Sethi 
Designation  Associate Consultant 
Affiliation  Sir Ganga Ram Hospital New Delhi 
Address  Department of Anaesthesiology Pain and Perioperative Medicine Sir Ganga Ram Hospital Old Rajinder Nagar

New Delhi
DELHI
110060
India 
Phone  01142252513  
Fax  01142252513  
Email  nitinsethi77@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Pain and Perioperative MedicineSir Ganga Ram Hospital New Delhi-110060 India 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain and Perioperative Medicine 
Address  Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi-110060 India 
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 Nitin Sethi  Department of Anaesthesiology Pain and Perioperative Medicine   Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi 110060 India
New Delhi
DELHI 
09717494498

nitinsethi77@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Inguinal hernia repair,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists (ASA) physical status I and II
2. age group 18–75 years
3. Patients undergoing laparoscopic extraperitoneal inguinal hernia repair  
 
ExclusionCriteria 
Details  1. Patients with pre-existing respiratory disease
2. Patients with uncontrolled hypertension and unstable coronary artery disease (CAD)
3. Patients with BMImore than 30 kg/m2

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in respiratory mechanics parameters viz. dynamic respiratory compliance (Cdyn) and work of breathing (WOB).
 
Time from induction of anaesthesia to end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in respiratory mechanics parameters viz. airway resistance (R), peak inspiratory pressure (PIP) and minute ventilation (MV)

2. Changes in haemodynamic parameters viz. heart rate and blood pressure.

 
Time from induction of anaesthesia to end of surgery 
 
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   Phase 4 
Date of First Enrollment (India)   15/07/2011 
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="6"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Laparoscopy is a  commonly  performed surgical procedure wherein gas is  insufflated into the  abdominal cavity to facilitate therapeutic and diagnostic surgery via an endoscope Most laparoscopic surgeries involve intraperitoneal insufflation of the abdominal cavity but now   a days extraperitoneal approach for various laparoscopic procedures such as inguinal hernia repair, prostatectomy and ligation of  a varicocele is commonly employed. A large number of elderly patients who often have preexisting cardiorespiratory disease present for laparoscopic extraperitoneal inguinal  hernia repair.

 Insufflation of the abdominal cavity has several adverse respiratory and cardiovascular effects. Changes in respiratory function include decrease in pulmonary compliance , decrease in lung volumes and an increase in peak airway pressure. Major haemodynamic changes include alterations in arterial blood pressure (i.e. hypotension and hypertension), arrhythmias, increased systemic vascular resistance and decreased cardiac output. 

The respiratory and cardiovascular changes seen during intraperitoneal insufflation have been extensively studied.Although, there are a few studies done to study the haemodynamic effects of extraperitoneal insufflation ,there are no such studies done to evaluate the effect of extraperitoneal insufflation on changes in respiratory mechanics. 

The purpose of our study is to examine the effect of extraperitoneal insufflation on changes in respiratory mechanics.

 

 

 
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