| CTRI Number |
CTRI/2024/06/069141 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
the significance of biomarkers in abdominal drain fluid for anastomotic leakage. |
|
Scientific Title of Study
|
Predictive value of perianastomotic drain fluid biomarkers in anastomotic leak: a cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjunath Maruti Pol |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences
(AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9990187137 |
| Fax |
|
| Email |
manjunath.pol123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta Bhartiya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences
(AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9996552211 |
| Fax |
|
| Email |
sweta.bhartiya96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweta Bhartiya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, B-1 ward, Surgery Block, All India Institute of Medical Sciences
(AIIMS), Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9996552211 |
| Fax |
|
| Email |
sweta.bhartiya96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines AIIMS New Delhi
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of Surgical Disciplines, fourth floor, Surgery Block, All India Institute of Medical Sciences (AIIMS),
Ansari Nagar, New Delhi
|
| 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 Sweta Bhartiya |
AIIMS Delhi |
Department of Surgical Disciplines, first floor, B-1 ward,
Surgery Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi, South DELHI
South
DELHI |
9996552211
sweta.bhartiya96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 – 70 Years
2. Both gender
3. Post-operative abdominal surgery undergone intestinal anastomosis
4. Patients can follow instructions and are ready for regular follow up
5. Able to provide informed and written consent
6. Non-trauma elective and emergency cases with small intestine perforation or obstruction.
7. Mesenteric ischemia or strangulation: Small Intestinal obstruction with segmental ischemia or gangrene
8. Tumour: small bowel mass , Small bowel malignancy with adequate negative margin
9. Entero-cutaneous fistula
10. Symptomatic benign disease such as Meckles diverticulum or perforated diverticulitis or intussusception of bowel needing resection and anastomosis
11. Incarcerated hernia
12. Patients with ileostomy for closure |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 70 years
2. Patients taking immunosuppressive therapy and chemotherapy.
3. Patients with known hematological disorders or malignancy.
4. Patients with known chronic liver or kidney disease
5. Auto-immune disease or immunodeficiency syndrome
6. Pregnant or lactating mother
7. Refusal to consent or participate in the study
8. Proximal diverting ostomy creation at the time of intestinal anastomosis
9. Patients receiving Albumin Supplementation during the period of the study.
10. Abdominal trauma with small intestine perforation or obstruction.
11. Active inflammatory bowel disease (Crohn’s enteritis with complications)
12. Anastomosis involving oesophagus, stomach, duodenum, colon and rectum
13. Patients on immunosuppressive drugs, post-chemotherapy or post-radiotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Diagnostic accuracy of drain fluid biomarkers in predicting anastomotic leak |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of ICU & hospital stay
2. Post-operative morbidity: Clavien- Dindo classification
3. Post-op complications: SSI, IA abscess, obstruction, Burst abdomen, AKI, LRTI, ARDS, DVT
4. Post-operative re-intervention
5. Quality of life
6. Cost-analysis
7. Mortality
|
1. Days
2. Clavien Dindo classification
3. Yes or No
4. Days
5. questionnaire
6. In rupees
7. Yes or No |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
29/06/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
| Justification for conduct of this study
- Anastomotic leak (AL) occurs when there is anastomosis dehiscence followed by leakage of intestinal contents into the peritoneum. The incidence of AL ranges from 2% to 20%.
- AL is one of the catastrophic complication following bowel anastomosis. Even though there several techniques of anastomosis described, none provide a leak proof outcomes. AL entails a complex post-operative course with increased morbidity and high short-term mortality (10 – 20%).
- AL usually presents with systemic inflammatory syndrome (SIRS), while the presentation may occasionally be asymptomatic. Patients are often taken up for imaging or damage control surgery when they present with clinical features of AL.
- Imaging has varying sensitivity and specificity for AL, and is not diagnostic. However, it can potentially delay the surgical procedure owing to its false negative findings.
- Despite several established risk factors and the numerous studies on this subject, AL is still difficult to predict, and on the contrary, AL with SIRS may rapidly worsen and despite intervention it may progress rapidly to mortality.
- In order to make diagnosis of AL at an early stage (prior to presentation), different methods other than imaging, like biomarkers of inflammation in serum and drain fluid are under investigations
- Serum biomarkers [such as total leucocyte count, C-reactive protein (CRP), cytokines (e.g., TNF-α, IL-6, IL-1β), serum lactate, and Procalcitonin (PCT)] have been utilised to detect AL. However, they were found be non-specific, had variable cut-off for values (e.g., CRP, PCT etc), and these became significantly positive (increased) only after the appearance of symptoms or SIRS.
- From the available literature, the pH, lactate and CRP of drain fluid has been investigated by a few, and have concluded that it is a promising tool in predicting AL. However, none of these biomarkers have yet been verified in large scale clinical trials and lacks validation. Additionally, these were tested for colorectal surgeries only, and not following small bowel anastomosis.
- Hence, this study is trying to find if drain fluid biomarkers could help in detecting AL prior to presentation (or SIRS) so that an intervention can be performed in a time frame that can reduce morbidity and save lives.
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