| CTRI Number |
CTRI/2024/03/064603 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
To Know Improvement In Symptoms After Laparoscopic And Open Cholecystectomy In Gall Stone Diseases. |
|
Scientific Title of Study
|
Evaluation Of Symptomatic Improvement After Laparoscopic And Open Cholecystectomy In Gall Stone Diseases A Longitudinal Study From A Tertiary Care Centre. |
| 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 Jagveer Jadon |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of General Surgery 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7080063358 |
| Fax |
|
| Email |
jagveersinhjadon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Kumar Singh |
| Designation |
Professor and HOD, Department of General Syrgery |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9997484037 |
| Fax |
|
| Email |
rajeev.singh00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Kumar Singh |
| Designation |
Professor and HOD, Department of General Syrgery |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
UTTARANCHAL
263139
India |
| Phone |
9997484037 |
| Fax |
|
| Email |
rajeev.singh00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Jagveer Jadon, Department of General Surgery 2nd floor, Dr. Susheela Tiwari Government Hospital, Haldwani, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Dr. Jagveer Jadon |
| Address |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand |
| 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 Jagveer Jadon |
Dr. Susheela Tiwari Hospital |
Department of General Surgery, 2nd floor, Susheela Tiwari Hospital, Haldwani, Nainital, Uttarakhand
Nainital
UTTARANCHAL |
7080063358
jagveersinhjadon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, GMC, Haldwani |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All cases presenting to surgery OPD and Emergency of Dr. SUSHEELA TIWARI HOSPITAL diagnosed to be a case of cholelithiasis. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. HIV 1 and 2,
3. Unstable mental status
4. Seriously ill patients..
5. Not willing to participate in this study.
6. Pregnant female
7. Asymptomatic cholelithiasis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of symptomatic improvement after laparoscopic and open cholecystectomy in gall stone disease |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study effectiveness of cholecystectomy.
2. Which symptoms can be attributed to presence of stones in GB.
3. Severity of symptoms in relation to the Gall stone disease.
4. Improvement of symptoms after cholecystectomy.
5. Causes of post cholecystectomy Syndrome
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
29/03/2024 |
| 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="6"
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
|
The present study is a longitudinal study done after approval of Institutional Ethics Committee in all patients of cholelithaisis presenting in OPD satisfying inclusion and exclusion criteria.
The study consist of
- Selection of patients.
- Detailed history and clinical examination.
- Appropriate Investigations.
- Follow-up during the post-operative phase.
- Analysis and interpretation
Cases including both open and
laparoscopic cholecystectomy. In this study we will compare the pre-operative
and post-operative value, with course of time at 1 month, 3months & 6
months interval. We will use the standard scales for the monitoring of both pre-operative
and post-operative symptoms.
For dyspepsia we will take the help of Glasgow Dyspepsia
Severity Score. This is a tool for global measurement of dyspepsia. Here also
the range is from minimum value (0) to maximum value (10). |