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CTRI Number  CTRI/2025/11/096745 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 02/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   HOW GALLBLADDER WALL THICKNESS AND C-REACTIVE PROTEIN LEVELS AFFECT OUTCOMES IN LAPAROSCOPIC CHOLECYSTECTOMY 
Scientific Title of Study   Correlation Of Pre-operative Gallbladder Wall Thickness And C-Reactive Protein With Operative And Post Operative Outcomes Of Laparoscopic Cholecystectomy 
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 Patel Akash Nareshkumar 
Designation  JUNIOR RESIDENT 
Affiliation  Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research  
Address  Department of Surgery, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9727041010  
Fax    
Email  patelakash.pa12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja Batra 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research  
Address  Department of Surgery, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9881165415  
Fax    
Email  drpoojabatra16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Batra 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research  
Address  Department of Surgery, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9881165415  
Fax    
Email  drpoojabatra16@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, 442001  
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College  
Address  Sawangi Meghe, Wardha, Maharashtra, India, 442001  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Patel Akash Nareshkumar  Jawaharlal Nehru Medical College   Department of Surgery Jawaharlal Nehru Medical College Sawangi Meghe Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA 		 9727041010

patelakash.pa12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: K82||Other diseases of gallbladder, (3) ICD-10 Condition: K819||Cholecystitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Undergoing laparoscopic cholecystectomy
Preoperative ultrasonographic measurement of gallbladder wall thickness (GBWT)and serum C-reactive protein (CRP) level assessment
Provision of informed written consent
 
 
ExclusionCriteria 
Details  Gallbladder perforation diagnosed preoperatively
Choledocholithiasis
Pregnancy
Recent trauma
Active malignancy
Concurrent other infections or sepsis
Patient on Anti-inflammatory drugs
Uncontrolled systemic comorbidities
Patients unwilling or withdrawing consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To asses the pre-operative evaluate gall bladder thickness and C-reactive protein.
2) To evaluate the association of preoperative gallbladder wall thickness (GBWT)) with operative difficulty (using Nassar criteria), operative and postoperative outcomes in patients undergoing laparoscopic cholecystectomy. 3) To evaluate the association of C-reactive protein (CRP) levels with operative difficulty (using Nassar criteria), operative and postoperative outcomes in patients undergoing laparoscopic cholecystectomy.
 		 Pre-op US GB wall thickness: within 7 days prior to surgery (document exact interval).
Baseline CRP: within 48–72 hours prior to surgery .
Follow-ups: after 7–10 days and 30 ±7 days (for post operative outcomes).
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To determine the predictive value of combined GBWT and CRP in anticipating intraoperative complexity.
2) To analyze the correlation of GBWT and CRP levels with postoperative complications like wound infection, bile leak, jaundice.

 		 Pre-operative: GBWT USG within 7 days before surgery ; CRP within 24-48 hr pre-op
Intra-operative: real-time recording (during surgery).
Post-op Day 1 (POD1)
Post-op Day 3 (POD3)
Post-op Day 7 (±2 days)
Post-op Day 30 (±7 days)
 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   19/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This study aims to establish the predictive value of preoperative gallbladder wall thickness (GBWT) and C-reactive protein (CRP) levels in anticipating intraoperative difficulty, operative time, conversion rates, and postoperative complications in patients undergoing laparoscopic cholecystectomy. The expected outcome is a significant correlation between elevated GBWT/CRP and increased surgical complexity. Identifying these markers preoperatively can aid surgeons in better case selection, improve surgical preparedness, and reduce intraoperative complications. It can also assist in counseling patients regarding possible risks and outcomes, thereby enhancing shared decision-making. This evidence can contribute to clinical guidelines by incorporating GBWT and CRP into preoperative assessment protocols, especially in resource-limited settings where advanced imaging or scoring systems are unavailable. Moreover, it will add to the existing literature on surgical risk stratification and may influence future research on preoperative optimization in biliary surgery. Ultimately, this study has the potential to improve surgical outcomes and promote safer laparoscopic practices.

 
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