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CTRI Number  CTRI/2025/07/090782 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Comparative study 
Study Design  Other 
Public Title of Study   Comparative study of laproscopic and open cholecystectomy for symptomatic gall stone disease  
Scientific Title of Study   Comparative study of laproscopic and open cholecystectomy for symptomatic gall stone disease  
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 PS Powar 
Designation  Professor  
Affiliation  Varun arjun medical College and hospital  
Address  Varun arjun medical College and hospital, NH 24, Banthara, Shahjahanpur, Uttar Pradesh 242307

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  8766941685  
Fax    
Email  Panditpowar90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PS Powar 
Designation  Professor  
Affiliation  Varun arjun medical College and hospital  
Address  Varun arjun medical College and hospital, NH 24, Banthara, Shahjahanpur, Uttar Pradesh 242307

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  8766941685  
Fax    
Email  Panditpowar90@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr PS Powar 
Designation  Professor  
Affiliation  Varun arjun medical College and hospital  
Address  Varun arjun medical College and hospital, NH 24, Banthara, Shahjahanpur, Uttar Pradesh 242307

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  8766941685  
Fax    
Email  Panditpowar90@gmail.com  
 
Source of Monetary or Material Support  
Varun arjun medical College and hospital  
 
Primary Sponsor  
Name  Kanishka patel 
Address  Sai sadan infront of k.k. inter college etawah  
Type of Sponsor  Other [Self] 
 
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 
Kanishka patel   Varun arjun medical College and hospital   Varun arjun medical College and hospital NH 24 Banthara Shahjahanpur Uttar Pradesh 242307
Shahjahanpur
UTTAR PRADESH 		 7351547511

kanishk.shriniwas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee, VAMC, Banthara Shahjahanpur Uttar Pradesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Open cholecystectomy/ laproscopic cholecystectomy   1 year time period  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  75.00 Day(s)
Gender  Both 
Details  Patients diagnosed with symptomatic gallstone disease (e.g., biliary colic, cholecystitis).
2. Age range: 18-75 years.
3. Both genders included.
4. Patients fit for general anesthesia (ASA I or II). 
 
ExclusionCriteria 
Details  1. Patients with complicated gallstone disease (e.g., cholangitis, pancreatitis).

2. Previous upper abdominal surgery leading to adhesions.
3. Patients with contraindications for laparoscopy (e.g., uncontrolled coagulopathy, severe cardiopulmonary diseases).
4. Pregnant women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1- Comparison of operative time, postoperative pain, and complications 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of hospital stay, recovery time, and cost-effectiveness.   
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/07/2025 
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="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   “Comparative Study of Laparoscopic and Open Cholecystectomy for Symptomatic Gall Stone Disease”
Submitted by: Dr. Kanishka Patel
Course: MS General Surgery (2023–2026)
Institution: Varun Arjun Medical College & Rohilkhand Hospital, Shahjahanpur, UP
1. Introduction:
Cholecystectomy is the standard treatment for symptomatic gallstones. Laparoscopic cholecystectomy (LC) has largely replaced open cholecystectomy (OC) due to advantages like:
Smaller incisions
Less postoperative pain
Shorter hospital stays
Faster recovery
However, safety concerns in complex cases still persist. This study compares both methods to guide surgical decision-making.

2. Review of Literature:
Operative Time: Initially longer for LC but now comparable as surgical experience has grown.
Hospital Stay & Recovery: LC results in significantly shorter stays and quicker return to normal activities.
Pain: Postoperative pain is consistently lower with LC.
Complications: OC and LC have comparable complication rates. LC had more bile duct injuries early on, now reduced.
Cost-Effectiveness: Though LC is costlier initially, it is more cost-effective long term.
Patient Satisfaction: Higher with LC due to faster recovery and better cosmetic results.
Recent Advances: SILS and robotic-assisted surgeries show promise for even better outcomes.

3. Aim & Objectives:

Aim:
To compare outcomes of laparoscopic vs. open cholecystectomy in symptomatic gallstone disease.

Objectives:

1. Compare operative time
2. Compare postoperative pain
3. Evaluate hospital stay
4. Compare complications
5. Assess patient satisfaction
6. Analyze cost-effectiveness

4. Materials and Methods:
Study Type: Prospective, comparative study
Duration: 1 year
Setting: Varun Arjun Medical College & Rohilkhand Hospital
Sample Size: 60 patients (30 LC, 30 OC)
Inclusion: Adults (18–75 years) with symptomatic gallstones, ASA I/II
Exclusion: Complicated gallstones, prior abdominal surgeries, severe comorbidities, pregnancy
Randomization: Computer-generated or sealed envelope technique
Surgical Technique:
LC: 4-port technique
OC: Right subcostal incision
Data Collection Parameters:
Demographics: Age, sex, BMI, comorbidities
Operative data: Operative time, intra-op complications, conversion rates
Postoperative data: Pain score (VAS), complications, hospital stay, recovery, scar assessment
Follow-up: 1 week, 1 month, 3 months
Statistical Tests: Chi-square, Fisher’s exact, t-test (Significance: p < 0.05)
5. Ethical Considerations:
Approval from the Institutional Ethics Committee
Informed consent in English & Hindi
Patient confidentiality maintained
Participation voluntary, with no effect on standard care
Risks and benefits explained
No insurance coverage; institutional care in case of complications
6. Consent Form Highlights:
Explained in native language
Participant can withdraw anytime
Consent for use of anonymous data in publications
Details regarding duration, benefits, risks, and confidentiality provide
7. Study Proforma Includes:
Personal details
History (complaints, medical/surgical/family/social)
Examination (general, abdominal)
Investigations (CBC, LFT, USG, etc.)
Diagnosis
Treatment & follow-up plan
8. Gantt Chart:

(To be submitted as per institutional format showing proposed timeline)

 
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