| CTRI Number |
CTRI/2024/11/077088 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see clinical outcome of patients who underwent difficult laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Clinical, Biochemical and Imaging Outcomes Following Difficult Laparoscopic Cholecystectomy: An Ambispective 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 |
Mohammed Motiwala |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Room 204, Surgery Block, AIIMS, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
08980956292 |
| Fax |
|
| Email |
motiwalamohammed97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Room 419, 4th floor, Surgery Block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810359760 |
| Fax |
|
| Email |
rajinderparshad@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Motiwala |
| Designation |
Senior Resident |
| Affiliation |
AIIMS |
| Address |
Room 204, Surgery Block, AIIMS, New Delhi, Ansari Nagar East
New Delhi
DELHI
110029
India |
| Phone |
08980956292 |
| Fax |
|
| Email |
motiwalamohammed97@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari nagar, East, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mohammed Motiwala |
All India Institute of Medical Sciences, New Delhi |
Room No. 18n Ground floor, Surgery Block, Ansari Nagar, new Delhi
New Delhi
DELHI |
08980956292
motiwalamohammed97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who underwent laparoscopic cholecystectomy meeting with working definition of difficult laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Malignancy on histopathology
Refusal to consent
Lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess short term surgical, symptomatic and biochemical outcomes at 3 months in patients undergoing difficult cholecystectomy in prospective arm
• To assess long term symptomatic, biochemical and radiological outcomes at minimum 1 year in patients undergoing difficult cholecystectomy |
3 months & 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess Quality of Life using GIQLI (Gastro Intestinal Quality of Life Index) at 3-6 months in patients undergoing difficult cholecystectomy in prospective arm |
3-6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/12/2024 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Laparoscopic Cholecystectomy is considered the gold standard procedure for gall stone diseases. Laparoscopic cholecystectomy has shown to improve symptoms and quality
of life in patients suffering from symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy for difficult gall
bladders, including subtotal cholecystectomy, also report positive improvements
in symptoms and quality of life post-surgery. But these patients tend to have
longer hospital stay attributed to SSI, readmission and intervention for
retained stones, bile leak in post operative period. These complications can
impact on quality of life in longer times.
This study aim to assess the outcome of difficult laparoscopic cholecystectomy in terms of clinical, biochemical and imaging parameters. |