| CTRI Number |
CTRI/2019/08/020644 [Registered on: 09/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Intra-abdominal pressure in the outcomes of perforation peritonitis. |
|
Scientific Title of Study
|
Evaluation of Serial Measurement of Intra-abdominal Pressure in the Outcomes of Perforation Peritonitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pritesh Kumar N |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Surgery,
2nd floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi, Central Delhi, India 110002
Central
DELHI
110002
India |
| Phone |
9632297674 |
| Fax |
|
| Email |
pkn644@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pawan Lal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Surgery,
2nd floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi, Central Delhi, India 110002
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
pawanlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Lal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Surgery,
2nd floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi, Central Delhi, India 110002
Central
DELHI
110002
India |
| Phone |
|
| Fax |
|
| Email |
pawanlal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgery,
2nd floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi, Central Delhi, India 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College New Delhi |
| Address |
Department of Surgery,
2nd floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi, Central Delhi, India 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Pritesh Kumar N |
Maulana Azad Medical College and associated Lok Nayak Hospital |
Department of Surgery, 2nd floor, B. L. Taneja Block, Maulana Azad Medical College, New Delhi, Central Delhi, India 110002
Central
DELHI |
9632297674
pkn644@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K650||Generalized (acute) peritonitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of perforation peritonitis undergoing intervention in the form of emergency laparotomy.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.History of previous abdominal surgery
3.Failed urethral catheterization |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Values of intra-abdominal pressure |
1.At presentation
2.Just before induction of GA
3.Post-induction of GA
4.24 hours after surgery
5.48 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
All-cause mortality at 30 days post-laparotomy.
Duration of hospital stay,
Occurrence of burst abdomen,
Prolonged ileus.
Organ dysfunction. |
At presentation
24 hours after surgery
48 hours after surgery
72 hours after surgery
Day of discharge
30th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/08/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intra-abdominal pressure is raised in many abdominal surgical emergencies and has implications on patient outcomes in terms of both morbidity and mortality. An ideal method of measuring the intra-abdominal pressure would be by use of an intra-abdominal transducer. However, indirect methods have been found to give a good estimate of the same. The present study utilizes bladder catheterization and saline manometry to measure the intra-abdominal pressure as per WSACS guidelines and to correlate the same with the outcomes of perforation peritonitis using objective scoring systems such as APACHE and SOFA.
|