| CTRI Number |
CTRI/2026/04/109283 [Registered on: 24/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Postoperative c reactive protein testing to predict anastomotic leak in patients after bowel surgery |
|
Scientific Title of Study
|
Crp( c reactive protein) as a predictive marker in anastomotic leak |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Sri guru Ramdas insitute of medical sciences and research,Vallabh,Amritsar |
| Address |
Surgery unit 4 floor 2nd south side sgrd vallah , Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9855435868 |
| Fax |
|
| Email |
dr_arun_gupta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Manpreet Sharma |
| Designation |
Surgery junior resident |
| Affiliation |
Sri guru Ramdas institute of medical sciences and research, vallah, Amritsar |
| Address |
Surgery unit 4 floor 2 south side , vallah, Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
8837880089 |
| Fax |
|
| Email |
Manpreet78sharma93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Sri Guru Ramdas institute of medical sciences and research vallah, Amritsar |
| Address |
Surgery unit4 floor 2 nd south side ,Sgrd vallah, Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9855435868 |
| Fax |
|
| Email |
Dr_arun_gupta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri guru ram Das university of medical sciences |
| Address |
Surgery unit 4 floor 2 nd south side room no 1vallah,sgrd,Amritsar , Punjab pin code 143501 |
| Type of Sponsor |
Private 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 |
| DrArun Kumar Gupta |
Department of Surgery |
Sri guru ram das institute of medical sciences and research room no 1south side 2 nd floor ,vallah,Amritsar,Punjab pincode 143501
Amritsar
PUNJAB |
9855435868
dr_arun_gupta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitee |
Approved |
| Institutional ethics comittee |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 18 years and above
Patients undergoing elective gastrointestinal surgery involving vowel anastomosis ( eg colorectal,small bowed or gastric)
Patients with primary anastomosis without diverting stoma |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of postoperative C-reactive protein levels in predicting anastomotic leak, measured by sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic (ROC) curve. |
Primary time point-POD 3 CRP
Secondary time points- POD 4 and POD 5
Optional: include pod 1-2 for trend analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="50"
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)
|
05/05/2026 |
| 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="5"
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
|
Crp as a predictive marker in anastomotic leak Anastomotic leak remains one of the most serious complications following gastrointestinal surgery, contributing significantly to postoperative morbidity, mortality, prolonged hospital stay, and increased healthcare costs. Early diagnosis of anastomotic leak is challenging due to its often subtle and nonspecific clinical presentation in the immediate postoperative period. Therefore, there is a need for reliable, easily available biomarkers that can facilitate early detection or safe exclusion of this complication. C-reactive protein (CRP) is an acute-phase reactant synthesized by the liver in response to inflammatory stimuli and is routinely measured in the postoperative setting. This thesis evaluates the role of postoperative CRP as a predictive marker for anastomotic leak. Serial CRP levels were analyzed, with particular emphasis on postoperative day (POD) 3 to 5, a period during which physiological postoperative inflammation is expected to decline in uncomplicated cases. The study demonstrates that persistently elevated or rising CRP levels beyond POD 3 are significantly associated with the development of anastomotic leak. CRP showed high diagnostic accuracy, particularly a high negative predictive value, indicating its usefulness in excluding anastomotic leak when levels fall below established cut-off values. Receiver operating characteristic (ROC) analysis identified optimal CRP thresholds for predicting anastomotic leak, supporting its role as an early warning marker. |