| CTRI Number |
CTRI/2025/02/080970 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY TO UNDERSTAND THE EASINESS OF EARLY CHOLECYSTECTOMY AND INTERVAL CHOLECYSTECTOMY IN PATIENTS OF ACUTE CHOLECYCTITIS |
|
Scientific Title of Study
|
A Randomized Control Trial to assess feasibility of early cholecystectomy in patients of acute cholecystitis verses interval cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Verma |
| Designation |
Junior Resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of General Surgery
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES
Etawah
Uttar Pradesh
Department of General Surgery
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES
Etawah
Uttar Pradesh
PIN CODE 206130
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7678969578 |
| Fax |
|
| Email |
asha89golu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Profesor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of General Surgery
UPUMS
Etawah
Uttar Pradesh
Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9953177755 |
| Fax |
|
| Email |
dranilsjhdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha verma |
| Designation |
Junior Resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
R.N. 226 Department of General Surgery
UPUMS
Etawah
Uttar Pradesh
Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
7678969578 |
| Fax |
|
| Email |
asha89golu@gmail.com |
|
|
Source of Monetary or Material Support
|
| UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCE SAIFAI ETAWAH INDIA PIN CODE 206130 |
|
|
Primary Sponsor
|
| Name |
UPUMS Saifai Etawah |
| Address |
Saifai Etawah
pin code 206130 |
| 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 |
| Dr Asha verma |
UPUMS Saifai Etawah |
R.N. 226 Department of General Surgery Saifai Etawah pin cod 206130
Etawah
UTTAR PRADESH |
7678969578
asha89golu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences Saifai,Etawah(U.P.)-206130 Saifai,Etawah |
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 |
EARLY CHOLECYSTECTOMY |
EARLY (WITHIN 72 HOUR OF ONSET OF SYMPTOM) CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS PATIENTS |
| Comparator Agent |
INTERVENTIONAL CHOLECYSTECTOMY |
INTERVAL OF 6 TO 8 WEEKS AFTER ACUTE CHOLECYSTITIS |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
all patients with symptomatic gallstone disease with recent onset within 72 hours of typical pain.
Grade 1 Tokyo guidelines. |
|
| ExclusionCriteria |
| Details |
Patient who are not giving consent to be the part of study.
Patient with pancreatitis.
Patient of acute cholecystitis after 72 hours of symptom onset.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ESTABLISH THE FEASIBILITY OF EARLY CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS |
WITHIN 72 HOUR OF STARTING OF THE SYMPTOMS OF ACUTE CHOLECYSTITIS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the feasibility of early cholecystectomy as compared to interval cholecystectomy |
At 6 week intervel |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ozkardeş AB et al (2014), conducted a study to compare the clinical outcome and cost of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Sixty patients with acute cholecystitis were randomized into early (within 24 hours of admission) or delayed (after 6–8 weeks of conservative treatment) laparoscopic cholecystectomy groups. There was no significant difference between study groups in terms of operation time and rates for conversion to open cholecystectomy. On the other hand, total hospital stay was longer and total costs were higher in the delayed laparoscopic cholecystectomy group. Intraoperative and postoperative complications were recorded in 8 patients in the early laparoscopic cholecystectomy group, whereas no complications occurred in the delayed laparoscopic cholecystectomy group.Despite intraoperative and postoperative complications being associated more with early laparoscopic cholecystectomy compared with delayed intervention, early laparoscopic cholecystectomy should be preferred for treatment of acute cholecystitis because of its advantages of shorter hospital stay and lower cost.
Ahmad UJ et al (2020), conducted a study that total 100 patients with clinical diagnosis of acute cholecystitis, admitted in the surgical wards of Gauhati Medical College and Hospital during the period of 1st July 2017 to 30th June 2018 were selected for the study. 40 patients underwent early cholecystectomy (within 7 days of onset of symptoms) and 60 patients underwent elective or late cholecystectomy (after a gap of 6-8 weeks from the acute attack). In the present series the average duration of surgery was 90.37±11.96 minutes in the early group and 65.3±7.83 minutes for the elective group which is found to be statistically significant (p value<0.05). In the early surgery group 8.33% required conversion to open surgery. In the elective surgery group 3.63% required conversion. Wound infection, biliary leakage, bile duct injury, and respiratory tract infection was found to be statistically not significant between the two groups. Early cholecystectomy is feasible and safe for acute cholecystitis and is better method of treatment because of its shorter hospital stay, which is a major economic benefit to both the patient and health care system.
"To assess the feasibility of early cholecystectomy in the prevention of intraoperative complications, post operative complications, cost effectiveness, as compared to interval cholecystectomy" |