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CTRI Number  CTRI/2019/03/017958 [Registered on: 07/03/2019] Trial Registered Prospectively
Last Modified On: 03/03/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study for assessment of change in symptoms and quality of life following cholecystectomy (Gall bladder removal surgery) 
Scientific Title of Study   ASSESSMENT OF POST CHOLECYSTECTOMY SYMPTOMS AND QUALITY OF LIFE EVALUATION: A PROSPECTIVE COHORT STUDY 
Trial Acronym  ASPOQ 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Toshib G A 
Designation  Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE, New Delhi  
Address  Department of Surgical Disciplines Room No 5025, 5th Floor, Teaching Block, Ansari Nagar, New Delhi 110029, India Ph. No. 26593206, Fax. 91-11-26588641,26588663

New Delhi
DELHI
110029
India 
Phone  9818226267  
Fax  91-11-26588641  
Email  toshibga@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suhani 
Designation  Assistant Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE, New Delhi  
Address  Department of surgical disciplines, Room no. 5025, 5th floor, Teaching block, AIIMS, New Delhi All India Institute of Medical Sciences, Ansari Nagar east,New Delhi South DELHI 110029

New Delhi
DELHI
110029
India 
Phone  9868397697  
Fax  91-11-26588641  
Email  drsuhani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Toshib G A 
Designation  Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCE, New Delhi  
Address  Department of surgical disciplines, Room no. 5025, 5th floor, Teaching block, AIIMS, New Delhi All India Institute of Medical Sciences, Ansari Nagar east,New Delhi South DELHI 110029

New Delhi
DELHI
110029
India 
Phone  9818226267  
Fax    
Email  toshibga@gmail.com  
 
Source of Monetary or Material Support  
Department of surgical disciplines, Room no. 5025, 5th floor, Teaching block, AIIMS, New Delhi 
 
Primary Sponsor  
Name  Department of Surgical Disciplines 
Address  Room no. 5025, 5th floor, Teaching block, AIIMS, New Delhi 
Type of Sponsor  Government 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 Toshib G A  ALL INDIA INSTITUTE OF MEDICAL SCIENCES (AIIMS), New Delhi, Department of surgical disciplines   Room no. 5025, 5th floor,Department of surgical disciplines, Teaching block, AIIMS, New Delhi South DELHI
New Delhi
DELHI 		 9818226267
91-11-26588641
toshibga@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a) Patients with cholelithiasis undergoing minimally invasive cholecystectomy.
b) Age greater than or equal to 18 years.
 
 
ExclusionCriteria 
Details  a)Patients suspected or diagnosed case of carcinoma gall bladder.
b)Patients undergoing cholecystectomy along with other surgery(for instance hernia repair in same sitting).
c) Patients undergoing open cholecystectomy.
d) Patients deemed unfit for General Anaesthesia. e) Patients not giving consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief of pre-operative symptoms and change in the quality of life after minimally invasive cholecystectomy.
 		 Pre-operative and then Follow up at around 01 week, 03 months and 6 months after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Persistence and/or emergence of new symptoms following minimally invasive cholecystectomy.  Follow up at around 01 week, 03 months and 6 months after surgery. 
 
Target Sample Size   Total Sample Size="159"
Sample Size from India="159" 
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)   10/03/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Minimally invasive cholecystectomy (which includes Laparoscopic / Robotic Cholecystectomy) is emerging as one of the most commonly performed elective surgical procedures performed worldwide.

However, the audit of symptom improvement and emergence of newer symptoms post minimally invasive cholecystectomy is lacking in the literature.

Further, the literature of impact of minimally invasive cholecystectomy on Quality of Life especially for patients with atypical symptoms and asymptomatic Gall stones is scant.

Hence, we wish to undertake this study to perform an audit of symptom improvement and emergence of newer symptoms and Quality of Life post minimally invasive cholecystectomy.

 
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