| CTRI Number |
CTRI/2024/12/078131 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of laparoscopic totally extraperitoneal hernia repair with and without prophylactic antibiotics. |
|
Scientific Title of Study
|
Comparison of laparoscopic totally extraperitoneal hernia repair with and without prophylactic antibiotics: A randomized controlled study |
| 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 Ananya Dilip |
| Designation |
Post graduate resident doctor |
| Affiliation |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Department of Surgery Maulana Azad Medical College and
Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9971428110 |
| Fax |
|
| Email |
ananyadilip123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anubhav Vindal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College And Associated Lok Nayak Hospital |
| Address |
Department of Surgery Maulana Azad Medical College and
Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Dilip |
| Designation |
Post graduate resident doctor |
| Affiliation |
Maulana Azad Medical College And Associated Lok Nayak Hospital |
| Address |
Department of Surgery Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9971428110 |
| Fax |
|
| Email |
ananyadilip123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi -110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital,
New Delhi 110002 |
| 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 Ananya Dilip |
Lok Nayak Hospital |
Department of Surgery Maulana Azad Medical College and
Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India
New Delhi
DELHI |
9971428110
ananyadilip123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Maulana Azad Medical college and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patient receiving placebo(10ml of normal saline) |
The patients will be informed about randomization and possibility of being allotted to any of the 2 groups and consent for participation obtained. All patients will undergo antibiotic sensitivity testing as a part of their preoperative preparation. Patients will be randomized at induction of anesthesia. The anesthetist will be given 2 syringes marked A (1.2 g of Inj. Amoxyclav reconstituted in 10ml of normal saline) and B (placebo-10ml of normal saline).The staff nurse will be asked to pull out a sealed envelope which will reveal patient’s allocation into one of the two groups and enter the same in an allocation table, which will be reviewed by the primary researcher only at the end of the study. The anesthetist will administer one of the two syringes based on this allocation without the knowledge of operating surgeon or primary researcher. All patients will undergo laparoscopic inguinal hernia(TEP) repair by the same primary surgeons in a day care setting. |
| Intervention |
Patient receiving single dose of pre operative prophylactic antibiotic ( Inj. Amoxyclav 1.2 mg IV ) |
The patients will be informed about randomization and possibility of being allotted to any of the 2 groups and consent for participation obtained. All patients will undergo antibiotic sensitivity testing as a part of their preoperative preparation. Patients will be randomized at induction of anesthesia. The anesthetist will be given 2 syringes marked A (IV injection of 1.2 g of Inj. Amoxyclav reconstituted in 10ml of normal saline) and B (placebo-10ml of normal saline).The staff nurse will be asked to pull out a sealed envelope which will reveal patient’s allocation into one of the two groups and enter the same in an allocation table, which will be reviewed by the primary researcher only at the end of the study. The anesthetist will administer one of the two syringes based on this allocation without the knowledge of operating surgeon or primary researcher.
All patients will undergo laparoscopic inguinal hernia(TEP) repair by the same primary surgeons in a day care setting.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients of symptomatic inguinal hernia presenting to surgery outpatient department at Lok Nayak Hospital, New Delhi and planned for laparoscopic inguinal hernia surgery |
|
| ExclusionCriteria |
| Details |
1. Recurrent inguinal hernia,
2. Antibiotic intake 48 hours prior to surgery ,
3. Evidence of diabetes mellitus, other immunocompromised states and conversion to open procedure and
4. Pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of SSI (evidenced by development of redness, swelling, discharge or increase in pain over staple line in a period of 30 days post op) as defined by CDC classification. |
At 48hrs,1week,2week,4 weeek |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative pain using Visual Analogue
Scale (VAS) score |
At 6 hours,discharge,24 hours,1 week |
| Duration of hospital stay |
Pre, intra and post procedure |
| Patient satisfaction (Likert scale) |
At discharge, 1 week, 4 weeks |
| Post operative complications (Clavien Dindo classification) |
48hours, 1 week,2 week, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
24/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Despite extensive research in literature regarding randomized controlled studies evaluating the efficacy of prophylactic antibiotics in laparoscopic totally extraperitoneal repair (TEP), we were unable to find any. The only studies were observational or evaluated the role in open inguinal hernia repairs.Hence, the present study was designed to assess the role of prophylactic antibiotics in laparoscopic inguinal hernia repair.The Guidelines of the European Hernia Society for the treatment of inguinal hernia concluded that antibiotic prophylaxis does not significantly reduce the number of wound infection.This is a randomized placebo-controlled study designed to evaluate the role of prophylactic antibiotics in laparoscopic totally extraperitoneal hernia repair at a single center in New Delhi, India. The primary outcome measures will be occurence of surgical site infection (CDC classification) .The secondary outcomes will be post operative complications, post operative pain , duration of hospital stay and patient satisfaction. |