| CTRI Number |
CTRI/2024/02/062240 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
BETTER RECOVERY IN PATIENTS AS COMPARED TO TRADITIONAL APPROACH IN PATIENTS AFTER LAPAROSCOPIC SURGERY |
|
Scientific Title of Study
|
ENCHANCED RECOVERY AFTER SURGERY VERSUS TRADITIONAL PROTOCOL IN LAPROSCOPIC SURGERIES |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tessy George |
| Designation |
Resident, Department of Anaesthesiology |
| Affiliation |
P.D.U Medical college and Hospital Rajkot |
| Address |
Department of Anesthesiology, New OPD building, P.D.U Medical college and hospital,Rajkot, Gujarat-360001
Rajkot
GUJARAT
360001
India |
| Phone |
8547718336 |
| Fax |
|
| Email |
tessygeorge24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Vandana Parmar |
| Designation |
Head of department of anesthesiology |
| Affiliation |
P.D.U Medical college and Hospital Rajkot |
| Address |
Department of Anesthesiology, New OPD building, P.D.U Medical college and hospital,Rajkot, Gujarat-360001
Rajkot
GUJARAT
360001
India |
| Phone |
8320966490 |
| Fax |
|
| Email |
drvandanapithadia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tessy George |
| Designation |
Resident, Department of Anaesthesiology |
| Affiliation |
P.D.U Medical college and Hospital Rajkot |
| Address |
PDU MEDICAL COLLEGE AND HOSPITAL
DEPARTMENT OF ANESTHESIOLOGY
NEW OPD BUILDING, 3rd floor, RAJKOT Gujarat-360001
Rajkot
GUJARAT
360001
India |
| Phone |
8547718336 |
| Fax |
|
| Email |
tessygeorge24@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDU MEDICAL COLLEGE AND HOSPITAL, RAJKOT |
|
|
Primary Sponsor
|
| Name |
Dr Tessy George |
| Address |
Department of Anaesthesiology
New OPD building
PDU Medical college and Hospital |
| 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 |
| DR TESSY GEORGE |
P.D.U MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, NEW OPD BUILDING, 3RD FLOOR RAJKOT, GUJARAT-360001
Rajkot
GUJARAT |
8547718336
tessygeorge24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics committe,PDU Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective laparoscopic surgery under general anesthesia
2.ASA grade I, II,III |
|
| ExclusionCriteria |
| Details |
ASA IV, V
Uncontrolled systemic disease
Emergency operations
Respiratory and cardiac disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesic requirement and readiness to discharge |
Immediate postop,15min,30min,2 hourly,6hourly,12hourly,24hourly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Early mobilisation
Early oral intake
postoperative nausea and vomiting
|
immediate postop,15mins,30mins,2hourly,6hourly,12hourly,24hourly |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/02/2024 |
| 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
|
· The preoperative fasting, patient education, minimize starvation, giving 25gms oral carbohydrate drink, minimize bowel preparation, optimization of co-morbidities and hemoglobin · Intraoperative haemodynamic control, oxygenation, intravenous fluid, use of antihypertensives. · Postoperative early oral intake, mobilization, urinary catheter removal and need for recatherization, requirement of post operative analgesia, postoperative nausea and vomiting
|