| 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
|
|
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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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Inguinal hernia repair, |
|
|
Intervention / Comparator Agent
|
|
|
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
|
|
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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.
|