| CTRI Number |
CTRI/2024/09/074344 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk factors associated with conversion of laparoscopic cholecystectomy to open cholecystectomy – A Prospective Observational study |
|
Scientific Title of Study
|
Preoperative and intraoperative risk factors associated with conversion of laparoscopic cholecystectomy to open cholecystectomy – A Prospective Observational 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 |
Dr Shesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of General Surgery UPUMS Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7351539585 |
| Fax |
|
| Email |
drsheshkrverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of General Surgery UPUMS Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7351539585 |
| Fax |
|
| Email |
drsheshkrverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of General Surgery UPUMS Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7351539585 |
| Fax |
|
| Email |
drsheshkrverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| UPUMS Saifai Etawah, Uttar Pradesh, India - 206130 |
|
|
Primary Sponsor
|
| Name |
Uttar pradesh university of Medical sciences |
| Address |
Saifai, Etawah, Uttar Pradesh, India - 206130 |
| Type of Sponsor |
Government 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 |
| Mohammad Atif |
UP University of Medical Sciences |
Dept of General Surgery, 2nd floor, Old building, UPUMS Saifai, Etawah
Etawah
UTTAR PRADESH |
07078157580
Atifkhan239@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, UPUMS, Saifai, Etawah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients admitted with clinical diagnosis of cholelithiasis and planned for laparoscopic cholecystectomy.
2. Patients able to give informed consent |
|
| ExclusionCriteria |
| Details |
1. Critically ill patients at high risk. 2. Patients with suspected or confirmed gall bladder cancer. 3. Patient not giving consent to be a part of study. 4. On further evaluation of the patient, different final diagnosis was confirmed. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Male gender ,old age ,history of previous abdominal surgery can be factors for conversion. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Raised ALP levels can be related to presence of CBD stones found intraoperatively.
Development of constitutional symptoms postoperatively can be related to preoperative variables. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
11/10/2024 |
| 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
|
One of the most common causes of abdominal pain is the presence of gallstons.Cholecystectomy is the only effective management of symptomatic gallstones, with 93% of gallbladder disease problems referred to surgeons. Laparoscopic cholecystectomy (LC) is a standard treatment for gallstone disease. LC results in a lower overall complication rate and shorter postoperative hospital stay compared to open cholecystectomy (OC). Identifying preoperative patient-related factors, anticipating the need to convert from laparoscopic cholecystectomy to open surgery, can help identify high-risk patients and redefine surgical strategy in this group. These predictive conversion factors can also improve patient safety and increase the cost-effectiveness of gallstone treatment. The study will be taking into account all patients planned for laparoscopic cholecystectomy, irrespective of their preoperative findings, so as to remove the operator bias. The study will be taking another step to bring to the table a scoring method, to advance the development of research into the stream of cholecystectomy. |