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CTRI Number  CTRI/2018/11/016338 [Registered on: 15/11/2018] Trial Registered Prospectively
Last Modified On: 03/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A study of causes of conversion of laparoscopic cholecystectomy to open surgery 
Scientific Title of Study   Factors affecting conversion of laparoscopic cholecystectomy to open surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poojitha Yalla 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9740604983  
Fax    
Email  poojithayalla@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajgopal Shenoy 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery New OPD block Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845243460  
Fax    
Email  kallyarajgopalshenoy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Poojitha Yalla 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9740604983  
Fax    
Email  poojithayalla@hotmail.com  
 
Source of Monetary or Material Support  
Department of general surgery, Kasturba Hospital, Manipal  
 
Primary Sponsor  
Name  Poojitha Yalla 
Address  Sonia Hostel, KMC Manipal, 576104 
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 
Dr Poojitha Yalla  Kasturba Hospital Manipal  Department of General Surgery R.No 19, 3rd floor New OPD Block Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 
9740604983

poojithayalla@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K81||Cholecystitis, (2) ICD-10 Condition: K80||Cholelithiasis, (3) ICD-10 Condition: K82||Other diseases of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients posted for laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  Gall bladder carcinoma.
Laparoscopy done, cholecystectomy not done/ procedure abandoned.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Identification of risk factors which cause conversion to open surgery.
Percentage of cases converted to open surgery. 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
To identify preoperative risk factors and intraoperative findings that affect conversion to open surgery  2 years 
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="310" 
Final Enrollment numbers achieved (Total)= "310"
Final Enrollment numbers achieved (India)="310" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/11/2018 
Date of Study Completion (India) 12/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Laparoscopic cholecystectomy is one of the most commonly performed laparoscopic surgeries, and conversion to open surgery in case of surgical difficulties or complications happens often. The factors affecting or causing conversion have been widely studied with different studies assessing different factors. 

 

The primary aim of this study is to assess the factors affecting conversion in our centre, Kasturba Hospital, Manipal and to compare the results with the studies done so far. 

 

All patients posted for laparoscopic cholecystectomy shall be included in the study, these patients shall be assessed preoperatively and postoperatively, using the proforma and in case of conversion to open surgery, the cause of conversion shall be documented. Intra-operative findings of all cases (irrespective of whether converted or not) will be assessed.

The data hence collected will be analyzed using statistical software.

 

Outcome Measures:

Identification of risk factors for conversion to open surgery, preoperatively, which could

  • Refine the process of preoperative counseling and informed consent of the patient with those risk factors.
  • Help in correcting any modifiable risk factors in these patients, thus reducing the chances of conversion

Identification of intra-operative findings which are more commonly associated with conversion, and hence a decision to open the abdomen could be taken earlier,

  • Thus reducing operative time.
  • Preventing any potential major complications which could reduce postoperative morbidity.

 


 
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