| CTRI Number |
CTRI/2022/11/047265 [Registered on: 14/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Advantage of UGI scopy in detecting other conditions , before Laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
Utility of UGI Scopy in symptomatic cholelithiasis patients before Laparoscopic Cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivarsha Balaji Kumar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery , 3 rd floor . Smt Sharada Madhav Pai OPD building , Kasturba Hospital , Manipal 576104
Tiger circle road , Madhav Nagar , Manipal , Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9444874920 |
| Fax |
|
| Email |
vivarsha.kumar@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Krishna M |
| Designation |
Professor & HOU |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery , 3 rd floor . Smt Sharada Madhav Pai OPD building , Kasturba Hospital , Manipal 576104
Tiger circle road , Madhav Nagar , Manipal , Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sunil.krishna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vivarsha Balaji Kumar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of General Surgery , 3 rd floor . Smt Sharada Madhav Pai OPD building , Kasturba Hospital , Manipal 576104
Tiger circle road , Madhav Nagar , Manipal , Karnataka - 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9444874920 |
| Fax |
|
| Email |
vivarsha.kumar@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital , Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Tiger circle road , Madhav nagar , Manipal , Karnataka - 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vivarsha Balaji Kumar |
Kasturba Medical college and Hospital |
Department of General Surgey and department of Gastroenterology , Smt.Sharada Madhav Pai OPD building , Kasturba hospital
Udupi
KARNATAKA |
9444874920
vivarsha.kumar@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Kasturba Medical college and Kasturba hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic cholelithiasis patients |
|
| ExclusionCriteria |
| Details |
-Age less than 18 years
-Complicated gall stone disease lile pancreatitis, cholangitis, cholecystitis
-USG findings like cholecystitis , empyema, polyps , adenomyomatous and CA gall bladder
Laparoscopy converted to open
Asymptomatic gall stone disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Age distribution of cholelithiasis
- Mean age
-Utility of UGI scopy
-Commonest upper GI symptoms associated with cholelithiasis
-Commonest finding in UGI scopy
-Pain score in pre operatively and post operatively
-Significance in pain reduction between 2 groups |
-Significance in pain reduction between 2 groups at immediate post op , within 1 month and between 1 to 3 months of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/11/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to determine the advantages of pre operative diagnosis and treatment of associated Esophgeal and gastric pathologies in view of post operative pain and other symptom reduction Also to evaluate the upper GI symptoms and UGI scopy findings in symptomatic gall stone patients |