| CTRI Number |
CTRI/2024/07/071617 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the patients who were given and those who were not given prophylacyic antibiotics before a planned laparoscopic gallbladder surgery |
|
Scientific Title of Study
|
Prophylactic antibiotic versus no antibiotic in patients undergoing elective laparoscopic cholecystectomy: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Kumar Roy |
| Designation |
Post graduate trainee, General Surgery |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Surgery
Regional Institute of Medical Sciences
Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9051274947 |
| Fax |
|
| Email |
skroy2303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan Maibam |
| Designation |
Assistant Professor, General Surgery |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Surgery
Regional Institute of Medical Sciences
Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9774524948 |
| Fax |
|
| Email |
cmaibam82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Kumar Roy |
| Designation |
Post graduate trainee, General Surgery |
| Affiliation |
Regional Institute of Medical Sciences, Imphal |
| Address |
Department of Surgery
Regional Institute of Medical Sciences
Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9051274947 |
| Fax |
|
| Email |
skroy2303@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgery, Regional Institute of Medical Sciences, Imphal |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Lamphelpat, Imphal West, Manipur, 790005 |
| Type of Sponsor |
Government medical college |
|
|
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 Suman Kumar Roy |
Regional Institute of Medical Sciences, Imphal |
Department of surgery, MSW 1/4 and FSW 1/4
Imphal West
MANIPUR |
9051274947
skroy2303@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
| Comparator Agent |
Injection CEFTRIAXONE SULBACTUM 1.5gm |
The other group will receive single dose Inj. Ceftriaxone + Sulbactum 1.5gm intravenously within one hour of surgery as prophylactic antibiotic |
| Intervention |
Normal saline |
10ml to be injected intravenously within 1 hour of start of surgery as placebo to group without prophylactic antibiotic |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed case of Gall stone disease/ GB polyp/ Chronic cholecystitis
2.≥18 years of age
|
|
| ExclusionCriteria |
| Details |
1.Antibiotic use within 7 days of planned laparoscopic cholecystectomy
2.Mucocele, Empyema, Gangrenous gall bladder
3.Preoperative ERCP or concomitant choledocholithiasis
4.Medical comorbidities (e.g. Diabetes, Malignancy, Immunocompromised)
5.Patients requiring antibiotics for any other reasons
6.Intraoperative gall bladder rupture or biliary spillage |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Surgical site infection
2.Duration of hospital stay |
1.Post Operative Day 1
2.Post Operative Day 2
3.Post Operative Day 7
4.Post operative Day 14
5.Post operative Day 21
6.Post operative Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative infectious complications |
1.Post Operative Day 1
2.Post Operative Day 2
3.Post Operative Day 7
4.Post operative Day 14
5.Post operative Day 21
6.Post operative Day 30 |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
Final Enrollment numbers achieved (Total)= "190"
Final Enrollment numbers achieved (India)="190" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
10/02/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Antibiotics should be used judiciously to prevent the development of antibiotics resistance, adverse effects as well to reduce the cost of treatment. There is great need for a more stringent and uniform use of antibiotics prophylaxis in general surgery. This study is aimed to compare the incidence of surgical site infections in patients undergoing elective laparoscopic cholecystectomy with prophylactic antibiotic and no antibiotic. This is a randomized controlled study to be carried out in the Department of Surgery, RIMS, Imphal. The duration of the study will be of around 02 years from July 2024 to June 2026. A total of 172 patients admitted in Department of surgery, RIMS, Imphal for undergoing laparoscopic cholecystectomy would be included as governed by inclusion/exclusion criteria. 86 patients will be allocated randomly to either group (with prophylactic antibiotic or no antibiotic group) using computer generated random tables. After obtaining ethical clearance, informed consent will be taken from the patients after explaining the nature and purpose of the study being done. Participants will be blinded. The patients will be subjected to a detailed pre-operative, intra-operative and post operative assessment. Patients would be followed up for a period of 30 days after surgery and observations will be noted. Surgical site infections if any will be treated and patient will be followed up till SSI resolves. After the study period, data will be analysed for statistical significance. The findings of this randomized controlled trial will be tabulated graphically. Descriptive statistics will be used for data analysis. There is no such study done in this region (North Eastern part of India) in the past which compares the incidence of surgical site infections in elective laparoscopic cholecystectomy with prophylactic antibiotic versus without antibiotic hence my study will help in addressing the research gap and contribute valuable insights to the existing literature.
|