| CTRI Number |
CTRI/2023/07/054683 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparision of two methods in the patients with open abdomen |
|
Scientific Title of Study
|
Comparision of negative pressure abdominal dressing versus Bogota bag application in patients with laparostomy-A Randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amipara Rajdeepkumar Vrajlal |
| Designation |
Post Graduate |
| Affiliation |
Maulana azad medical college |
| Address |
Department of genenral surgery
2nd floor, BL Taneja block,MAMC new delhi
2nd floor, BL Taneja block,MAMC new delhi
New Delhi
DELHI
110002
India |
| Phone |
8866151780 |
| Fax |
|
| Email |
amipararajdeepkumar1000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Ghuliani |
| Designation |
professor |
| Affiliation |
Maulana azad medical college |
| Address |
Department of genenral surgery
2nd floor, BL Taneja block,MAMC new delhi
2nd floor, BL Taneja block,MAMC new delhi
New Delhi
DELHI
110002
India |
| Phone |
9899326388 |
| Fax |
|
| Email |
drdeepakghuliani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amipara Rajdeepkumar Vrajlal |
| Designation |
Post Graduate |
| Affiliation |
Maulana azad medical college |
| Address |
Department of genenral surgery
2nd floor, BL Taneja block,MAMC new delhi
2nd floor, BL Taneja block,MAMC new delhi
New Delhi
DELHI
110002
India |
| Phone |
8866151780 |
| Fax |
|
| Email |
amipararajdeepkumar1000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery, MAMC-New delhi |
|
|
Primary Sponsor
|
| Name |
AMIPARA RAJDEEPKUMAR VRAJLAL |
| Address |
Department of general surgery,
2nd floor BL taneja block,MAMC New delhi |
| 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 |
| Dr Amipara Rajdeepkumar Vrajlal |
MAMC and associated hospitals |
department of general surgery 2nd floor, bl taneja block mamc nenw delhi.
New Delhi
DELHI |
8866151780
amipararajdeepkumar1000@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: K659||Peritonitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
negative abdominal pressure dressing |
After emergency surgery abdomen will be temporarily closed by Negative Pressure Abdominal Dressing |
| Comparator Agent |
comparator-2:Bogota bag application |
After emergency surgery abdomen will be temporarily closed by bogota bag application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Significant bowel edema precluding abdominal wall closure.
Significant fecal peritonitis with >500ml of enteric contents/pus.
|
|
| ExclusionCriteria |
| Details |
Pregnancy.
Bleeding Diathesis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Days for definitive primary abdominal wall closure(closure of midline fascial layers and skin |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of Hospital stay.
Burst abdomen rate
|
every day till 1 month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/07/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Once the patient is planned for emergency laparotomy by midline incision the patient will undergo emergency necessary investigations and will be taken for emergency surgery, depending upon intraoperative findings the decision of laparostomy will be taken than abdomen will be temporarily closed by Negative Pressure Abdominal Dressing or Bogota bag application as per randomization. after that both methods will be assessed on basis of time taken to closed the abdomen primarily. |