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Clinical Trials/CTRI/2024/10/075667
CTRI/2024/10/075667Not yet recruitingNot Applicable

Evaluation of gasless diagnostic laparoscopy in assessment of patients presenting with acute abdomen

Maulana Azad Medical College1 site in 1 country65 target enrollmentStarted: November 2, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
65
Locations
1
Primary Endpoint
Rate of successful completion of gasless laparoscopy (visualisation of 10 of 12 structures as per list

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Patients of acute abdomen with hypotension who are not responding to fluid resuscitation after giving 2L IV fluids.
  • 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.

Outcomes

Primary Outcomes

Rate of successful completion of gasless laparoscopy (visualisation of 10 of 12 structures as per list

Time Frame: Baseline

Secondary Outcomes

  • 1) Detection rate of intra abdominal pathologies (no. of structure identified)(2) Surgeon satisfaction score)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

nithya k

Maulana Azad Medical College

Study Sites (1)

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