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
|
|
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
|
|
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. |