| CTRI Number |
CTRI/2025/01/079731 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the outcomes of the emergency exploratory laparotomy patients in terms of ICU and in-hospital mortality, who require intensive care in the perioperative setting (before or after operation), retrospectively and prospectively after implementing a co-designed care bundle. |
|
Scientific Title of Study
|
Impact of implementing co-designed care bundles on the outcomes of critically ill patients after emergency exploratory laparotomy-a pre-post analysis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Kumar Dey |
| Designation |
Senior Resident(Academic) |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesiology and Critical Care; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Central ICU; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9007559418 |
| Fax |
|
| Email |
amitkumardey.cmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Swagata Tripathy |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesiology and Critical Care; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Central ICU; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Swagata Tripathy |
| Designation |
Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Anesthesiology and Critical Care; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Central ICU; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8763400534 |
| Fax |
|
| Email |
tripathyswagata@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar, Sijua, Patrapada, Bhubaneswar, Odisha, India. PIN 751019 |
|
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Primary Sponsor
|
| Name |
Amit Kumar Dey |
| Address |
Senior Resident (Academic), Department of Anesthesiology and Critical Care; All India Institute of Medical Sciences Bhubaneswar; Sijua; Patrapada; Bhubaneswar, Odisha, India. PIN 751019.
Central ICU; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar, Odisha, India. PIN 751019. |
| Type of Sponsor |
Other [Amit Kumar Dey] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Swagata Tripathy |
AIIMS Bhubaneswar |
Department of Anesthesiology and Critical Care; AIIMS Bhubaneswar; Sijua; Patrapada; Bhubaneswar
Khordha
ORISSA |
8763400534
tripathyswagata@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee; AIIMS Bhubaneswar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AIIMS emergency laparotomy quality improvement care bundle (AEL-QICB) |
Components of the bundle- According to the ERAS Society recommendation on emergency laparotomy, the perioperative bundle of care for patients undergoing emergency laparotomy has two components – a diagnostic pathway for early diagnosis and a resuscitation pathway before surgery, along with optimization measures in the postoperative period.
Diagnostic pathway-
1)Rapid assessment for physiological derangements by the Early Warning Scores (NEWS/MEWS)
2)Screen for sepsis/organ dysfunction by qSOFA, Blood tests, ABG, Blood culture, and plasma glucose
3)Early imaging by CT scan/ USG
4)Interdepartmental coordination regarding intensive care
5)Source control within 6hr for non-septic patients and within 3hr for septic patients.
Resuscitation pathway-
1)Intravenous fluid for septic shock
2)Correct acid-base disorder, dyselectrolytemia and blood glucose
3)Broad-spectrum appropriate antibiotics
4)Nasogastric decompression to prevent aspiration
5)Urinary catheter to monitor organ perfusion
6)Patients should be risk assessed before surgery using validated tools like P-POSSUM (The Portsmouth Physiological and Operative Severity Score) or the NELA (National Emergency Laparotomy Audit) score for the enumeration of Mortality and morbidity
Intensive care management post-emergency exploratory laparotomy involves a multidisciplinary approach.
This includes vigilant monitoring, advanced life support, and comprehensive care bundles tailored to each patients needs. Critical aspects of ICU management include hemodynamic support, respiratory care, meticulous fluid and electrolyte balance, effective pain management, and stringent infection control measures, which are already standard practice. |
| Comparator Agent |
Current institutional practice |
Current institutional practice
No specific bundle care is followed. |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing emergency exploratory (upper and lower midline incision) laparotomy for the acute disease process, trauma, or surgical complication required intensive care in the perioperative period
Patients requiring concurrent general thoracotomy are also included
|
|
| ExclusionCriteria |
| Details |
1)Patients under 16 years of age
2)Elective laparotomy
3)Appendicectomy of any type as the sole surgical procedure
4)Cholecystectomy of any type as the sole surgical procedure
5)Gynecological laparoscopy or laparotomy of any type unless the primary pathology is proven to be general surgical
6)Surgery related to organ transplantation
7)Emergency laparotomy for vascular surgery
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare perioperative outcomes of the patients undergoing emergency exploratory laparotomy before and after implementing the AIIMS Emergency Laparotomy Quality Improvement Care Bundle (AEL-QICB).
Primary objective- To compare the ICU and in-hospital mortality between the two study populations. |
Primary outcome-ICU and in-hospital mortality will be assessed within 30 days of hospitalization. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objectives-
Day 30 mortality
ICU length of stay
ICU Re-admission rate
|
All secondary outcomes will be assessed within 30 days of hospitalization. |
|
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Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
01/03/2025 |
| 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="10"
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
|
Emergency exploratory laparotomy is a critical surgical procedure often performed on patients with acute abdominal conditions with an annual incidence of around one in a thousand population. Bowel obstruction and bowel perforation, along with bowel ischemia, account for the majority of the patient population. The incidences and burden of the acute surgical abdomen in India are comparable worldwide. Given the urgency and complexity of the surgery, emergency laparotomy carries very high mortality and morbidity worldwide. Although the underlying pathology varies pre-operatively, often, the patients are elderly and very sick with sepsis and organ dysfunction. Preparing these patients for high-risk surgery consumes a meaningful amount of hospital resources, although crucial for optimizing outcomes and reducing morbidity and mortality rates. Multinational studies reported a short-term mortality of 7-21% and an even higher (26.6%) long-term mortality, along with a significant proportion (23.8%) requiring ICU admission. Exploratory laparotomy patients requiring ICU care have documented considerable morbidity and mortality (33%, 1-year mortality and 59.4%, 5-year mortality) along with higher resource utilization. Independent predictors of mortality were older age(>62), high APACHE-II score, peri-operative immunosuppression, and delayed admission to the ICU. Several quality improvement initiatives have been implemented worldwide, like the UK Emergency Laparotomy Network (ELN), emergency laparotomy pathway quality improvement care (ELPQuiC), Enhanced Peri-Operative Care for High-risk Patients (EPOCH), ERAS exploratory Laparotomy 2022 etc, with mixed results. Data on acute care in emergency exploratory laparotomy are lacking in lower-middle-income countries, especially populous countries like India. |