| CTRI Number |
CTRI/2024/12/078321 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
CLINICORADIOLOGICAL MARKERS IN PREDICTING A DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY - AN OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
CLINICORADIOLOGICAL MARKERS IN PREDICTING A DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY - AN OBSERVATIONAL STUDY |
| Trial Acronym |
CLINICORADIOLOGICAL MARKERS IN PREDICTING A DIFFICULT LAPAROSCOPIC CHOLECYSTECTOMY - AN OBSERVATIONAL STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DRSHRISHAILMETGUD@GMAIL.COM |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR HARSH M SONEJI |
| Designation |
JR, MS GENERAL SURGERY |
| Affiliation |
KLE JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
KLE DR PRABHAKAR KORE HOSPITAL
NEHRU NAGAR
590010
BELAGAVI KARNATAKA
Belgaum
KARNATAKA
590010
India |
| Phone |
9148335444 |
| Fax |
|
| Email |
harshsoneji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHRISHAIL C METGUD |
| Designation |
MS GENERAL SURGERY |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
KLE DR PRABHAKAR KORE HOSPITAL
NEHRU NAGAR BELAGAVI
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448110157 |
| Fax |
|
| Email |
DRSHRISHAILMETGUD@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRISHAIL C METGUD |
| Designation |
MS GENERAL SURGERY |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
KLE DR PRABHAKAR KORE HOSPITAL
NEHRU NAGAR BELAGAVI
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448110157 |
| Fax |
|
| Email |
DRSHRISHAILMETGUD@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR HARSH M SONEJI |
| Address |
KLE DR PRABHAKAR KORE HOSPITAL
NEHRU NAGAR 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 HARSH M SONEJI |
KLE DR PRABHAKAR KORE HOSPITAL, BELAGAVI |
KLE DR PRABHAKAR KORE HOSPITAL, NEHRU NAGAR, BELAGAVI
Belgaum
KARNATAKA |
9148335444
harshsoneji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE, JNMC BELAGAVI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with Gall stone disease |
|
| ExclusionCriteria |
| Details |
Patients who have undergone cholecystectomy
Patients with pancreatitis
Pregnancy
Immunocompromised patients
History of any major GI surgery
Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and radiological markers to predict if a laparoscopic cholecystectomy will be difficult or not. |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
30/12/2024 |
| 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 Yet Recruiting |
| 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
|
To use the clinical and radiological parameters to predict a laparoscopic cholecystectomy will be difficult or easy. |