CTRI Number |
CTRI/2019/08/020882 [Registered on: 26/08/2019] Trial Registered Prospectively |
Last Modified On: |
23/08/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
COMPARISON OF SAME DAY DISCHARGE LAPAROSCOPIC CHOLECYSTECTOMY WITH IN HOSPITAL STAY LAPAROSCOPIC CHOLECYSTECTOMY FOR CHRONIC GALL STONE DISEASE |
Scientific Title of Study
|
RANDOMIZED CONTROLLED STUDY COMPARING DAY CARE AND CONVENTIONAL
LAPAROSCOPIC CHOLECYSTECTOMY FOR CHRONIC CHOLECYSTITIS. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Anubhav Vindal |
Designation |
Professor of Surgery |
Affiliation |
Maulana Azad Medical College |
Address |
ROOM NO. 215 Department of Surgery 2nd floor BLT Block
Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi India
Central DELHI 110002 India |
Phone |
9968604403 |
Fax |
|
Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Anubhav Vindal |
Designation |
Professor of Surgery |
Affiliation |
Maulana Azad Medical College |
Address |
ROOM NO. 215 Department of Surgery 2nd floor BLT Block
Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi India
Central DELHI 110002 India |
Phone |
9968604403 |
Fax |
|
Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Saurav Kumar |
Designation |
Postgraduate student |
Affiliation |
Maulana Azad Medical College |
Address |
ROOM NO.410 Old Resident Doctors Hostel
Maulana Azad Medical College, Bahadurshah Zafar Marg,New Delhi India
Central DELHI 110002 India |
Phone |
9953284461 |
Fax |
|
Email |
srv428@gmail.com |
|
Source of Monetary or Material Support
|
Maulana Azad Medical College
Bahadurshah zafar marg New Delhi 110002 |
|
Primary Sponsor
|
Name |
Maulana Azad Medical College |
Address |
Maulana Azad Medical College
Bahadurshah Zafar marg
New Delhi
11002 |
Type of Sponsor |
Other [University Teaching 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 |
Anubhav Vindal |
Maulana Azad Medical College |
Department of Surgery
Maulana Azad Medical College
Bahadurshah Zafar marg Central DELHI |
9968604403
anubhav.vindal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K811||Chronic cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Conventional Laparoscopic Cholecystectomy |
Patients will have an overnight hospital stay |
Intervention |
Day care laparoscopic cholecystectomy |
Patients will be discharged on same day |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.All patients of confirmed cholelithiasis proven on USG without complications.
2. ASA grade 1 and 2
3. Responsible adult company at home until the next morning after surgery
4. Able to understand instructions (including the post-surgery primary care giver)
5. Home within the radius of 15km radius of LokNayak hospital in National capital territory of Delhi.
Capable of reaching the hospital on their own without depending on assistance from the hospital |
|
ExclusionCriteria |
Details |
1.Complicated gall stone disease (acute
cholecystitis, gallstone pancreatitis, cholangitis,
choledocholithiasis)
2.Patients with previous abdominal surgery. |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Discharge rate |
7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Time to return to activities of daily living
2. Hospital stay
3. Patient satisfaction |
7 day |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
26/08/2019 |
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="0" Months="0" Days="30" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nill |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The study aims to compare day care laparoscopic cholecystectomy and conventional laparoscopic Cholecystectomy with resprct to discHarge rate.
Since
its introduction, laparoscopic cholecystectomy (LC) has become the treatment of
choice for symptomatic gallbladder disease. Although the operation
itself has remained essentially unchanged since its introduction, there has
been significant evolution in the manner in which patients undergoing
laparoscopic cholecystectomy are managed. In its early application,
all patients were hospitalized overnight following the procedure. Recently
there has been a shift from hospital admission to the use of "short-stay
units" or "23-hour admissions," in hope of providing an economic
advantage to the laparoscopic approach.
Many
studies have documented the safety and feasibility of day care LC in an
ambulatory surgery unit in selected patients. These, however,
emanate from countries with hospitals that have dedicated ambulatory surgery
units and have well-established norms and protocols for day care surgery. The
results of this day care laparoscopic cholecystectomy are promising in the
developed nations, but performing laparoscopic
cholecystectomy on an outpatient basis is not generally accepted in the
developing nations, due to lack of equipped day care centres and transport
problems
Health
authorities, quality assurance agencies, and surgeons in developing countries
have traditionally been reluctant to advocate outpatient surgery because of
major resource variations and inequity in quality of health care delivery. Consequently,
there has been little or no attempt to study the feasibility and safety of
outpatient LC in these countries. This study has been designed to develop
outpatient LC in a tertiary health care hospital of a developing country
without a free standing facility or department for day care surgery. |