| CTRI Number |
CTRI/2025/11/098014 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Keyhole surgery or drain tube: which heals a liver abscess faster? |
|
Scientific Title of Study
|
Laparoscopic drainage versus image guided pigtail catheter drainage for liver abscess - a randomized control 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 Fathima Firoze |
| Designation |
M.S general surgery post graduate student |
| Affiliation |
Aarupadai Veedu medical college and hospital;Puducherry |
| Address |
Department of General surgery, room number 10, C block, Aarupadai veedu medical college and hospital , Pondy Cuddalore main road, Kirumampakkam, Pondicherry, India, Pin code: 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
6238565313 |
| Fax |
|
| Email |
fathimafiroze2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akmal A |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of General surgery, room number 10, C block, Aarupadai veedu medical college and hospital , Pondy Cuddalore main road, Kirumampakkam, Pondicherry, India, Pin code: 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8939932440 |
| Fax |
|
| Email |
aakmal04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shriram |
| Designation |
Associate Professor, Department of radiology |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of Radiology, B block, Aarupadai veedu medical college and hospital , Pondy Cuddalore main road, Kirumampakkam, Pondicherry, India, Pin code: 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9048576155 |
| Fax |
|
| Email |
radioshri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, room number 10, C block, Aarupadai veedu medical college and hospital, Pondy Cuddalore main road, kirumampakkam , Pondicherry, India. Pin code: 607403 |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu medical college and hospital |
| Address |
Aarupadai veedu medical college and hospital, Pondy Cuddalore main road, Kirumampakam, Pondicherry, India. Pincode:607403 |
| Type of Sponsor |
Private 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 Fathima Firoze |
Aarupadai Veedu medical college and hospital |
Department of general surgery, room number 10, C block, Aarupadai veedu medical college and hospital, Pondy Cuddalore main road, Kirumampakkam, Pondicherry, India. Pin code :607403
Pondicherry
PONDICHERRY |
6238565313
fathimafiroze2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee , Aarupadai Veedu medical college and hospital,Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K750||Abscess of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic drainage of liver abscess |
Intervention is a surgical procedure; will be done once and the average duration would be 60 minutes |
| Comparator Agent |
USG guided pigtail catheter drainage of liver abscess |
Comparator is a procedure; will be done once and the average time would be 30-45 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Alcoholics, single abscess |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathies, malignancy, patients with systemic hypertension and cardiac disease, multiple abscesses |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
6, 24, 48 hours, Day 3 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding |
6, 24, 48 hours, Day 3 & Day 7 |
| Duration of hospital stay |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="1"
Months="6"
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
|
Liver abscess is most common visceral abscess. I am doing a study between laparoscopic drainage of liver abscess and USG guided pigtail catheter drainage of liver abscess and comparing post operative complications and duration of hospital stay. |