| CTRI Number |
CTRI/2024/03/064220 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Difficulty assessment of surgery in patients with gall bladder inflammation |
|
Scientific Title of Study
|
Correlation of the Severity of Acute Cholecystitis with the Technical Challenges of Laparoscopic Cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padala Sahithi |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery, Kasturba Hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9963298057 |
| Fax |
|
| Email |
padala1.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Steffi Jennifer Dcruz |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery, Kastruba Hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7204662780 |
| Fax |
|
| Email |
steffi.dcruz@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshen M Samuel |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery, Kasturba Hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8123306328 |
| Fax |
|
| Email |
roshen.samuel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Padala Sahithi |
| Address |
Department of General Surgery, Kasturba Hospital, Manipal |
| 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 Padala Sahithi |
Kasturba Hospital |
Room No:5,Department of General Surgery, 3rd floor, Surgery OPD Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
9963298057
padala1.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K810||Acute cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute cholecystitis based on Tokyo 18 guidelines at Kasturba Hospital, Manipal |
|
| ExclusionCriteria |
| Details |
Patients failing to get laparoscopic cholecystectomy at Kasturba Hospital, Manipal |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnosis and assessment of severity of acute cholecystitis |
At Admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the difficulty of laparoscopic cholecystectomy |
At the time of laparoscopic cholecystectomy |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
23/03/2024 |
| 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="9"
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
|
Patients
admitted with acute cholecystitis at Kasturba Hospital, Manipal will be recruited for the study after taking
informed consent. The grade of acute cholecystitis will be assessed according
to the Tokyo guidelines 18 and the patient will be followed up till the surgery
and the difficulty of the surgery will be assessed according to the difficulty
score described by Iwashitha et al. This study aims to correlate the severity of acute cholecystitis with the difficulty of laparoscopic cholecystectomy.
|