CTRI Number |
CTRI/2023/11/059957 [Registered on: 17/11/2023] Trial Registered Prospectively |
Last Modified On: |
15/11/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparision between early laparoscopic cholecystectomyand delayed laparoscopic cholecystectomy in acute cholecystitis. |
Scientific Title of Study
|
EARLY VERSUS DELAYED LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
NITU SINGH |
Designation |
POST GRADUATE TRAINEE |
Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
Address |
DEPARTMENT OF SURGERY,SILCHAR MEDICAL COLLEGE AND HOSPITAL
Cachar ASSAM 788014 India |
Phone |
8210596588 |
Fax |
|
Email |
nitus0803@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SIDDHARTHA SANKAR BHATTACHARJEE |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
Address |
DEPARTMENT OF SURGERY,SILCHAR MEDICAL COLLEGE AND HOSPITAL
Cachar ASSAM 788014 India |
Phone |
9435071196 |
Fax |
|
Email |
sidharth_dr@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
SIDDHARTHA SANKAR BHATTACHARJEE |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
Address |
DEPARTMENT OF SURGERY,SILCHAR MEDICAL COLLEGE AND HOSPITAL
Cachar ASSAM 788014 India |
Phone |
9435071196 |
Fax |
|
Email |
sidharth_dr@yahoo.com |
|
Source of Monetary or Material Support
|
Silchar Medical College and Hospital,Ghungoor,Masinpur,Silchar,Uttar Krishnapur, Assam ,788014 |
|
Primary Sponsor
|
Name |
NITU SINGH |
Address |
SILCHAR MEDICAL COLLEGE AND HOSPITAL,GHUNGOOR, MASINPUR,SILCHAR, UTTAR KRISHNAPUR, ASSAM, 788014 |
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 |
DrNITU SINGH |
SILCHAR MEDICAL COLLEGE AND HOSPITAL |
OFFICE ROOM OF SURGERY DEPARTMENT ,1ST FLOOR, DEPARTMENT OF SURGERY ,SILCHAR MEDICAL COLLEGE AND HOSPITAL Cachar ASSAM |
8210596588
nitus0803@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Silchar Medical College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K810||Acute cholecystitis, (2) ICD-10 Condition: K810||Acute cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
DELAYED LAPAROSCOPIC CHOLECYSTECTOMY |
DELAYED LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS |
Intervention |
EARLY LAPAROSCOPIC CHOLECYSTECTOMY |
EARLY LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients who have been clinically and radiologically diagnosed as acute cholecystitis along with patients who have been previously diagnosed as a case of cholecystitis brought to the hospital with acute attack and planned for laparoscopic cholecystectomy. |
|
ExclusionCriteria |
Details |
1)All patients who are medically unfit for laparoscopic cholecystectomy
2)Persisting symptoms or failure of medication
3)Acute Calculus Cholecystitis with CBD stones
4)Perforation/peritonitis
5)Chronic Cholecystitis
6)Common bile duct stones
7)Carcinoma of Gall Bladder
8)Empyema Gall Bladder
9)Emphysematous Cholecystitis |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY |
3 DAYS |
|
Secondary Outcome
|
Outcome |
TimePoints |
Early laparoscopic cholecystectomy morbidity & mortality are similar to those of elective delayed cholecystectomy |
12 months |
EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY |
6 WEEKS |
|
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
|
Phase 3 |
Date of First Enrollment (India)
|
20/12/2023 |
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
|
Acute cholecystitis is
the most common acute disease in hepatobiliary surgery and one of the most
common diseases in digestive tract surgery in general (1). With aging, the
incidence increases from 4% in the third decade to 27% in the seventh decade of
life (2). Biliary calculosis is undoubtedly a disease of modern man. At least
20% of the human population is thought to have cholelithiasis but in
the most developed countries of the world this percentage is higher. The fact
is that this disease is much more common in areas where the diet is irrational
(fat-rich and high- calorie diet).
The incidence of the
disease increases with age.
Women of childbearing age are more likely to suffer than men
(1.5-3.0:1). There is a 4F formula that is attractive but does not explain the
mechanism and occurrence of biliary calculosis (female, forty, fat and
fertile). It should also be known that almost 50% of biliary lithiasis is
asymptomatic and is detected accidentally during some clinical trials. Cholecystectomy is method of choice
for treatment of gallbladder calculosis.
Open cholecystectomy has been the “gold standard†for symptomatic cholelithiasis
for a century. However, in the last two decades the introduction of
laparoscopic cholecystectomy has revolutionized the treatment of gallbladder
calculosis (4).
Laparoscopic cholecystectomy is now
considered to be the procedure of choice that achieves a shorter recovery
period and reduced treatment costs. In earlier years acute cholecystitis was
regarded as a relative contraindication for laparoscopic cholecystectomy
because of inflammatory changes that impair tissue quality and make it difï¬cult
to accurately visualize anatomical structures.
As technological advances have been
accompanied by improvements in surgical performance laparoscopy has become the
“gold standard†in the treatment of chronic cholecystitis with cholelithiasis,
and over time the indications widen and acute gallbladder inflammation is also
resolved by laparoscopy. |