| CTRI Number |
CTRI/2025/08/092949 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Correlation between patients receiving different duration of antibiotics and postoperative infectious complications in patients undergoing Pancreaticoduodenectomy |
|
Scientific Title of Study
|
Antibiotic duration and infectious complications in patients undergoing Pancreaticoduodenectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rapolu Sri Chandana Deepthi |
| Designation |
Junior Resident |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department of General Surgery,5th Level,B Block,Nehru Hospital,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7470340499 |
| Fax |
|
| Email |
deepthichandana48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Lileswar Kaman |
| Designation |
Professor and Head of General Surgery |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department of General Surgery,5th Level,B Block,Nehru Hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009644 |
| Fax |
|
| Email |
kamanlil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rapolu Sri Chandana Deepthi |
| Designation |
Junior Resident |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department of General Surgery, 5th level, B block, Nehru hospital, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7470340499 |
| Fax |
|
| Email |
deepthichandana48@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of General Surgery, 5th level, B block, PGIMER, Sector 12 , Chandigarh |
| Type of Sponsor |
Research institution and 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 |
| RAPOLU SRI CHANDANA DEEPTHI |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF GENERAL SURGERY,5TH LEVEL, B BLOCK, NEHRU HOSPITAL, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH-12
Chandigarh
CHANDIGARH |
7470340499
deepthichandana@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: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antibiotic duration in patients undergoing pancreaticoduodenectomy |
In patients undergoing pancreaticoduodenectomy(Whipples procedure), are divided into two groups. Both the groups would be receiving same empirical antibiotic i.e. Inj Piperacillin+ Tazobactam 4.5g QID, or dose modification in case of patient with renal compromise but duration of antibiotic varies as Group A for 4 days and group B 8days.Later to assess the role of antibiotic duration in reduction of post operative infectious complications primarily surgical site infection, then rest intra abdominal abscess, postoperative pancreatitis, cholangitis and non specific infectious complications such as pneumonia. UTI, sepsis |
| Comparator Agent |
The incidence of infectious complications in patient undergoing pancreaticoduodenectomy |
Primary objective - To assess the effect of the antibiotic duration in two groups- Group A 4 days (96hr) and group B 8 days (192hr) with infectious complications mainly surgical site infection(SSI) post operatively. To study other infectious complications such as intra abdominal abscess, post operative pancreatitis, cholangitis and non specific complications such as pneumonia, urinary tract infection , sepsis and length of hospital stay |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
80.00 Day(s) |
| Gender |
Both |
| Details |
1. Patient willing to give consent for being participant in the study
2.Patient undergoing WHIPPLE- pancreaticoduodenectomy for benign and malignant etiology
3.Inj Piptaz( piperacillin + tazobactam) 4.5g IV four times a day empirically. Antibiotic will be replaced accordingly to intraoperative bile culture and sensitivity
4. Renal dose adjustment of Injection Piperacillin + Tazobactam will be considered in patients with renal compromise |
|
| ExclusionCriteria |
| Details |
1.Patient not giving informed consent
2.Patients undergoing total pancreatectomy. enucleation, distal pancreatectomy
3.Post operative complications other than infectious complications
4.If patients of Group A develop prolonged septic complications requiring extended antibiotic course will either be excluded or be accounted in group B
5. Patient developing organ failure, requiring mechanical ventilation or pressure support or ICU admission or operated outside or lost to follow up/absconded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of the antibiotic duration in two groups 4days (96hr) and 8 days(192hr) undergoing pancreaticoduodenectomy with infectious complications mainly surgical site infection (SSI) postoperatively |
TILL 4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see reduction of other post operative infectious complications such as intra abdominal abscess, post operative pancreatitis, cholangitis, and non specific such as pneumonia, urinary tract infection , sepsis and length of hospital stay |
TILL 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/08/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
TO STUDY THE EFFECT OF ANTIBIOTIC DURATION AND THE INCIDENCE OF INFECTIOUS COMPLICATIONS MAINLY SURGICAL SITE INFECTIONS (SSI) IN PATEINTS UNDERGOING PANCREATICODUODENECTOMY. A RANDOMIZED CONTROL STUDY |