| CTRI Number |
CTRI/2024/10/075667 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of gasless laparoscopy in assessment of patients presenting with acute abdomen |
|
Scientific Title of Study
|
Evaluation of gasless diagnostic laparoscopy in assessment of patients presenting with acute abdomen |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
nithya k |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 2A, room Non 202, Department of General Surgery, Maulana Azad Medical College, Bahadur Shah Zafar Marge, near Delhi Gate, Dariyaganj, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9953793347 |
| Fax |
|
| Email |
nithya0096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Mishra |
| Designation |
Professsor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 2A, room no 201, Department of General Surgery, Maulana Azad Medical College, Bahadur Shah Zafar Marge, near Delhi Gate, Dariyaganj, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9899797734 |
| Fax |
|
| Email |
anurag.alok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
nithya k |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 2A, Room No 202, Dept. Of General Surgery, Maulana Azad Medical College, Bahadur Shah Zafar Marge, near Delhi Gate, Dariyaganj, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9953793347 |
| Fax |
|
| Email |
nithya0096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi gate, Dariya Ganj, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, Bahadur Shah Zafar Marg, near Delhi Gate, Dariyaganj, New Delhi, 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 |
| Dr Nithya k |
Maulana Azad Medical College |
Department of General Surgery Maulana Azad Medical College, Bahadur Shah Zafar Marge, near Delhi Gate, Dariyaganj, New Delhi
New Delhi
DELHI |
9953793347
nithya0096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
nil |
| Intervention |
NIl |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients 18 years and above and less than 65 years age presenting with acute abdomen and are planned for Exploratory laparotomy who give consent for the study will be enrolled. |
|
| ExclusionCriteria |
| Details |
1) Patients of acute abdomen with hypotension who are not responding to fluid resuscitation after giving 2L IV fluids.
2) Patients of acute abdomen with history of previous laparotomy
3) Patients of acute abdomen who pregnant or are lactating
4)Patients of acute abdomen with BMI greater than or equal to 30.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of successful completion of gasless laparoscopy (visualisation of 10 of 12 structures as per list |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Detection rate of intra abdominal pathologies (no. of structure identified)
2) Surgeon satisfaction score
3) Time duration to complete diagnostic laparoscopy
4) Rate of missed finding
5)Intra operative complication of laparoscopy |
1) post operative day 0
2) Post operative day 0
3) Intra operative
4) Post operative day 0
5) Post operative day 0 |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
02/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute abdomen accounts for 4 – 9.1% of all visits to the emergency department. As
acute abdomen is time critical, early diagnosis is crucial for further
management. Majority of patients who present with acute abdomen undergo exploratory
laparotomy. The rate of negative laparotomy in which no significant findings
are there is variable, with LMIC having negative laparotomy rate of 17.6%. NELA
year 8 recorded a mortality rate of 9% in patients who underwent exploratory
laparotomy. For India, mortality rate post exploratory laparotomy is an
even higher number ranging from 20 to 33%. The increased mortality rate
in Low -Middle Income countries (LMIC) like India may be due to delayed
diagnosis and lack of facilities for adequate diagnosis. Laparotomy
related complications including SSI, fascial rupture, bleeding, seroma, anastomotic
leakage, strangulation or herniation, and the need for reoperation during the
same LOS is 31%. Medical complications including pneumonia, respiratory
dysfunction, pulmonary embolism, sepsis, acute kidney dysfunction, acute liver
dysfunction, stroke, asystole and resuscitation, heart failure and atrial
fibrillation were recorded in 53.6%. Even negative laparotomies are not
without any morbidity. Laparoscopy is the only exploration that can directly visualize the
abdominal cavity and diagnose peritonitis because of the presence of fluids in
paracolic gutters and Douglas and subphrenic and subhepatic spaces. Moreover,
it can visualize the affected organ. it will help to choose the right
place for the incision, such as in the case of perforated diverticulitis or a
difficult gynaecological problem; and finally, in other cases it will help to
avoid an unnecessary laparotomy. If the result of the laparoscopy is negative and
depending on the experience of the surgeon, unnecessary laparotomy can be
avoided In resource-limited healthcare settings in low-middle income countries,
many patients who require abdominal surgery undergo open laparotomy or go
without surgery altogether. Anecdotally, many abdominal conditions remain
undiagnosed due to lack of access to diagnostic imaging and diagnostic
procedures (i.e., endoscopy, laparoscopy). These resource deficiencies lead to
avoidable morbidity and mortality which could be reduced with access to
laparoscopic surgery. For resource-limited hospitals where diagnostic imaging
is unavailable, gasless laparoscopy is a financially affordable diagnostic
option. |