| CTRI Number |
CTRI/2024/06/069654 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
First hospital admission vs later hospital admission surgery for laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Index vs Interval Cholecystectomy After Mild Biliary Pancreatitis - AProspective Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kodali Akhila |
| Designation |
Junior resident |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8374738371 |
| Fax |
|
| Email |
kodali1.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajgopal Shenoy |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845243460 |
| Fax |
|
| Email |
rajgopal.shenoy@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Manasa U |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022229976 |
| Fax |
|
| Email |
manasa.u@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital , Manipal, Udupi, Karnataka, India. Pincode: 576104 |
|
|
Primary Sponsor
|
| Name |
Kodali Akhila |
| Address |
Department of General Surgery, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka, India. pincode : 576104 |
| Type of Sponsor |
Other [Kodali Akhila (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 Kodali Akhila |
Kasturba Hospital, Manipal |
Department of General Surgery, Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
8374738371
kodali1.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above age of 18 years admitted to Kasturba hospital, Manipal with a diagnosis of mild biliary pancreatitis and managed surgically by departments of General Surgery and Surgical
Gastroenterology.All cases of biliary pancreatitis regardless of comorbidities such as diabetes mellitus, hypertension, mild to moderate cardiovascular diseases. |
|
| ExclusionCriteria |
| Details |
All cases with age less than 18 years.
All cases who did not give consent for surgery.
Patients of pancreatitis of other etiology other than biliary causes.
All cases with severe respiratory failure and sever cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the outcome between early vs delayed cholecystectomy
To assess the intraoperative and postoperative complications of cholecystectomy in biliary pancreatitis
|
During hospital stay for surgery, at follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the reasons for conversion of laparoscopic cholecystectomy to open cholecystectomy
To compare the duration of hospital stay in laparoscopic vs open cholecystectomy |
During hospital stay for surgery, at follow up. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
08/07/2024 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Informed consent will be obtained from the patient, patient attenders will be explained about the need of the study, the questionnaire. Details of patient will be noted, a questionnaire will be filled which includes information related to age of the patient, gender, any comorbidities of patient, duration of symptoms, duration of hospital stay, investigations the patient underwent such as ultrasound scan, CECT, ERCP, MRCP, difficulty intraoperatively according to Nassar grade, injury to structures such as bile duct injury, bowel injury, post operative recovery will be assessed by Calvin Dindi classification. A follow up within 1 month( which is standard of care ) by OPD visit or telephone call, any complications will be recorded. Patient will be recruited from Department of General Surgery and Department of Surgical Gastroenterology. |