| CTRI Number |
CTRI/2022/03/041465 [Registered on: 29/03/2022] Trial Registered Prospectively |
| Last Modified On: |
25/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Predict Difficult Laparoscopic Cholecystectomy Preoperatively by a Scoring method. |
|
Scientific Title of Study
|
Pre operative Prediction of difficulty grading in laparoscopic cholecystectomy using Scoring method - A Cross sectional Descriptive study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNSubaashini |
| Designation |
Post Graduate(M.S General Surgery) |
| Affiliation |
Sri Venkateshwaraa Medical College and Research Centre |
| Address |
No 24,25,26,Sri Natesan Nagar,Achariyapuram,Villianur,
Pudhucherry.
Ariyur,Pudhucherry
Pondicherry
PONDICHERRY
605 110
India |
| Phone |
9487061694 |
| Fax |
|
| Email |
docsubaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTDeepu |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College and Research Centre |
| Address |
Sri Venkateshwaraa Medical College and Research Centre
Ariyur,Pudhucherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9626926023 |
| Fax |
|
| Email |
drdeepu.surgeon@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTDeepu |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College and Research Centre |
| Address |
Sri Venkateshwaraa Medical College and Research Centre
Ariyur,Pudhucherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9626926023 |
| Fax |
|
| Email |
drdeepu.surgeon@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College And Research Centre,Pudhucherry. |
|
|
Primary Sponsor
|
| Name |
sri venkateshwara medical college and research centre |
| Address |
ariyur,puducherry |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrNSubaashini |
Sri venkateshwaraa medical college and research centre |
OPD 11,
Department of General surgery.
Pondicherry
PONDICHERRY |
9487061694
docsubaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
all patients undergoing laparoscopic cholecystectomy for gall stone disease |
|
| ExclusionCriteria |
| Details |
1.laparoscopy to open conversion due to intraoperative suspicion of malignancy.
2.laparoscopy to open conversion due to gallbladder perforation diagnosed intraoperatively.
3.laparoscopy to open conversion for CBD stone. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| scoring given by preoperative workup using RANDHAWA AND PUJAHARI Scoring method. |
Maximum 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish relationship between preoperative clinical,diagnostic evaluation and intraoperative difficulty. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
04/04/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy is a very common surgical procedure done for gall stone disease. This study is done to evaluate the efficacy of RANDHAWA AND PUJAHARI scoring system by assessing the difficulty in doing laparoscopic cholecystectomy preoperatively. Thereby, it helps the surgeon to schedule time and team for surgery and also helps in intimating the patients for longer hospitalization and more intense postoperative care. |