| CTRI Number |
CTRI/2018/01/011355 [Registered on: 16/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Can yoga reduce the need of medication after surgery? |
|
Scientific Title of Study
|
A prospective clinical study to evaluate the role of prophylactic antibiotics in laparoscopic cholecystectomy patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit Gupta |
| Designation |
senior resident |
| Affiliation |
UP University of Medical Sciences |
| Address |
Room no 202
PRA building
UP University of Medical Sciences
Saifai, Etawah
Room no 202
PRA Building
Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8191879754 |
| Fax |
|
| Email |
drmohitguptams@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Singh |
| Designation |
Head of Department |
| Affiliation |
UP University of Medical Sciences |
| Address |
Room no 235
Department of Surgery
UP UMS
Saifai, Etawah
Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8191879754 |
| Fax |
|
| Email |
attitudeindian@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohit Gupta |
| Designation |
Senior Resident |
| Affiliation |
UP University of Medical Sciences |
| Address |
Room no 202
PRA building
UP UMS
Saifai, Etawah
Room no 202
PRA Building
Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8191879754 |
| Fax |
|
| Email |
drmohitguptams@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self funded |
| Address |
Saifai, Etawah |
| Type of Sponsor |
Other [investigators eg Dr Mohit Gupta] |
|
|
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 |
| mohit gupta |
UP University of medical sciences |
Department of Surgery
UP University of Medical Sciences
Saifai, Etawah
Etawah
UTTAR PRADESH |
8191879754
drmohitguptams@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University ethical board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
antibiotics |
inj ceftriaxone 1 gm i.v. both pre operatively and post operatively |
| Comparator Agent |
antibiotics |
inj ceftriaxone given preoperatively only |
| Comparator Agent |
no antibiotics given |
no antibiotics given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
informed consent given |
|
| ExclusionCriteria |
| Details |
complicated cases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| surgical site infection |
Day 2
discharge
stitch removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
fever
hospital stay |
day 2 dischrge |
|
|
Target Sample Size
|
Total Sample Size="452"
Sample Size from India="452"
Final Enrollment numbers achieved (Total)= "452"
Final Enrollment numbers achieved (India)="452" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2015 |
| Date of Study Completion (India) |
31/07/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published ie no publications done till now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study had been done a lot in literaure to compare the role of full dose antibiotivs versus single shot antibiotics but our multiarm study compares both of them with no antibiotics
after our study we concluded that single dose of preoperative antibiotics are sufficient and comparable to full dose pre and post operative antibiotics. but use of No antibiotics are still not justified |