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
|
|
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
|
|
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.
|