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CTRI Number  CTRI/2017/08/009208 [Registered on: 01/08/2017] Trial Registered Retrospectively
Last Modified On: 01/08/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to analyse the effect of intra abdominal pressure on the outcome of laparotomies 
Scientific Title of Study   Optimisation of intra abdominal pressure during the perioperative period and its effect on outcome in patients undergoing laparotomies in a tertiary care setting - An experimental study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashwin R 
Designation  MBBS, MS, MRCSEd 
Affiliation  Madurai Medical Collge 
Address  Department of General Surgery Govt. Rajaji Hospital, Madurai Medical College Alwarpuram Madurai - 625020

Madurai
TAMIL NADU
625020
India 
Phone  9952409865  
Fax    
Email  ashwin90ster@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr D Maruthu Pandian 
Designation  MS, FICS, FAIS 
Affiliation  Madurai Medical Collge 
Address  Head of department Department of General Surgery Govt. Rajaji Hospital, Madurai Medical College Alwarpuram Madurai - 625020

Madurai
TAMIL NADU
625020
India 
Phone  9443407777  
Fax    
Email  adharsh@live.com  
 
Details of Contact Person
Public Query
 
Name  Ashwin R 
Designation  MBBS, MS, MRCSEd 
Affiliation  Madurai Medical Collge 
Address  Department of General Surgery Govt Rajaji Hospital Madurai Medical College Alwarpuram Madurai 625020

Madurai
TAMIL NADU
625020
India 
Phone  9952409865  
Fax    
Email  ashwin90ster@gmail.com  
 
Source of Monetary or Material Support  
Madurai Medical College, Madurai, India 
 
Primary Sponsor  
Name  Ashwin R 
Address  13 bharathy st ellaipillaichavady 
Type of Sponsor  Other [self] 
 
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 
ashwin  Madurai Medical College  Department of General Surgery Govt. Rajaji Hospital, Madurai Medical College Alwarpuram Madurai - 625020 India
Madurai
TAMIL NADU 
9952409865

ashwin90ster@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  abdominal conditions that need emergency or elective laparotomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control arm  routine post operative follow up without intra abdominal pressure monitoring 
Intervention  Reducing Intra abdominal pressure post surgery  WCACS protocols are followed to reduce the intra abdominal pressure in patients after lapartomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients more than 18 years admitted in surgical wards and planned for emergency/ elective laparotomy 
 
ExclusionCriteria 
Details  1. Patients with pre-existing conditions that prevent insertion of a Foley’s catheter or pre-existing lesions of urinary bladder.
2. Patients where bladder injury is suspected.
3. Patients where rectus closure is not done in the same sitting.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
decreased incidence of post operative complications like wound dehiscence, rectus dehiscence. early detection of secondary peritonitis  early post operative period (within 2 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
decreased morbidity due to laparotomy in study arm  at discharge 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2016 
Date of Study Completion (India) 17/09/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Khan S, Verma AK, Ahmad SM, Ahmad R. Analyzing intra-abdominal pressures and outcomes in patients undergoing emergency laparotomy. J Emerg Trauma Shock. 2010;3(4):318–25 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction:

 

Intra abdominal pressure affects optimal function of various organ systems. The incidence of overt abdominal compartment syndrome in the post operative period is coming down with advances in intensive care. Eventually, the focus has now shifted to intra abdominal hypertension and its possible deleterious effects. This study analyses the effect of maintaining optimal IAP on outcome of laparotomies.

 

Materials and Methods:

 

This is a prospective, interventional study conducted among surgical inpatients planned for elective or emergency laparotomy. Eighty-four patients were enrolled and randomly allotted into two groups A and B. In both the groups, pre-operative and serial post-operative IAP measurements were done. In-group A, IAH was controlled using WCACS protocols. The rate of overall and individual complications was assessed.

 

Results:

 

The incidence of IAH in the preoperative period was 21% - 25% among elective laparotomies and 75– 79 % among emergencies. Incidence of post-operative IAH (0 hour value) and eventually at 6, 24 and 48 hours was analysed. The interventions were effective in reducing the intra-abdominal pressure as only two patients with IAH were recorded at the end of 24 hours. There was a significant decrease in overall complication rate (p = 0.029) and abdominal wall complications (p = 0.038). The decrease in the rate of anastomotic leak was not significant.

 

Conclusion:

 

The high incidence of perioperative IAH emphasises the need for perioperative IAP monitoring. Maintaining optimal IAP in the post operative period is vital as it reduces post laparotomy complications especially wound and rectus dehiscence and thereby reducing the morbidity.

 
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