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CTRI Number  CTRI/2019/08/020882 [Registered on: 26/08/2019] Trial Registered Prospectively
Last Modified On: 23/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF SAME DAY DISCHARGE LAPAROSCOPIC CHOLECYSTECTOMY WITH IN HOSPITAL STAY LAPAROSCOPIC CHOLECYSTECTOMY FOR CHRONIC GALL STONE DISEASE 
Scientific Title of Study   RANDOMIZED CONTROLLED STUDY COMPARING DAY CARE AND CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY FOR CHRONIC CHOLECYSTITIS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anubhav Vindal 
Designation  Professor of Surgery 
Affiliation  Maulana Azad Medical College 
Address  ROOM NO. 215 Department of Surgery 2nd floor BLT Block Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi India

Central
DELHI
110002
India 
Phone  9968604403  
Fax    
Email  anubhav.vindal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anubhav Vindal 
Designation  Professor of Surgery 
Affiliation  Maulana Azad Medical College 
Address  ROOM NO. 215 Department of Surgery 2nd floor BLT Block Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi India

Central
DELHI
110002
India 
Phone  9968604403  
Fax    
Email  anubhav.vindal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saurav Kumar 
Designation  Postgraduate student 
Affiliation  Maulana Azad Medical College 
Address  ROOM NO.410 Old Resident Doctors Hostel Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi India

Central
DELHI
110002
India 
Phone  9953284461  
Fax    
Email  srv428@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College Bahadurshah zafar marg New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College Bahadurshah Zafar marg New Delhi 11002 
Type of Sponsor  Other [University Teaching Hospital] 
 
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 
Anubhav Vindal  Maulana Azad Medical College  Department of Surgery Maulana Azad Medical College Bahadurshah Zafar marg
Central
DELHI 
9968604403

anubhav.vindal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K811||Chronic cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Laparoscopic Cholecystectomy  Patients will have an overnight hospital stay 
Intervention  Day care laparoscopic cholecystectomy  Patients will be discharged on same day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.All patients of confirmed cholelithiasis proven on USG without complications.
2. ASA grade 1 and 2
3. Responsible adult company at home until the next morning after surgery
4. Able to understand instructions (including the post-surgery primary care giver)
5. Home within the radius of 15km radius of LokNayak hospital in National capital territory of Delhi.
Capable of reaching the hospital on their own without depending on assistance from the hospital 
 
ExclusionCriteria 
Details  1.Complicated gall stone disease (acute
cholecystitis, gallstone pancreatitis, cholangitis,
choledocholithiasis)
2.Patients with previous abdominal surgery. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Discharge rate  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to return to activities of daily living
2. Hospital stay
3. Patient satisfaction 
7 day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   26/08/2019 
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="0"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nill 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study aims to compare day care laparoscopic cholecystectomy and conventional laparoscopic Cholecystectomy with resprct to discHarge rate.

Since its introduction, laparoscopic cholecystectomy (LC) has become the treatment of choice for symptomatic gallbladder disease. Although the operation itself has remained essentially unchanged since its introduction, there has been significant evolution in the manner in which patients undergoing laparoscopic cholecystectomy are managed. In its early application, all patients were hospitalized overnight following the procedure. Recently there has been a shift from hospital admission to the use of "short-stay units" or "23-hour admissions," in hope of providing an economic advantage to the laparoscopic approach.

Many studies have documented the safety and feasibility of day care LC in an ambulatory surgery unit in selected patients. These, however, emanate from countries with hospitals that have dedicated ambulatory surgery units and have well-established norms and protocols for day care surgery. The results of this day care laparoscopic cholecystectomy are promising in the developed nations, but performing laparoscopic cholecystectomy on an outpatient basis is not generally accepted in the developing nations, due to lack of equipped day care centres and transport problems

Health authorities, quality assurance agencies, and surgeons in developing countries have traditionally been reluctant to advocate outpatient surgery because of major resource variations and inequity in quality of health care delivery. Consequently, there has been little or no attempt to study the feasibility and safety of outpatient LC in these countries. This study has been designed to develop outpatient LC in a tertiary health care hospital of a developing country without a free standing facility or department for day care surgery.


 
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