| CTRI Number |
CTRI/2023/04/051406 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Laparoscopic drainage versus Percutaneous catheter drainage of liver abscess |
|
Scientific Title of Study
|
Comparison of laparoscopic versus percutaneous catheter drainage of solitary liver abscess-A randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nischay Gupta |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
GH-9/2, Ist floor, Paschim Vihar, New Delhi
Central
DELHI
110087
India |
| Phone |
7838689346 |
| Fax |
|
| Email |
nischayg50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nischay Gupta |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
GH-9/2, Ist floor, Paschim Vihar, New Delhi
Central
DELHI
110087
India |
| Phone |
7838689346 |
| Fax |
|
| Email |
nischayg50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nischay Gupta |
| Designation |
Post Graduate student |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
GH-9/2, Ist floor, Paschim Vihar, New Delhi
Central
DELHI
110087
India |
| Phone |
7838689346 |
| Fax |
|
| Email |
nischayg50@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital |
| Address |
Jawaharlal Nehru Marg, Near Delhi Gate, 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 Rajdeep Singh |
Lok Nayak Hospital |
Jawaharlal Nehru Marg, Central Delhi-110002
Central
DELHI |
9968604383
rajdeep.mamc@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: K750||Abscess of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic Liver abscess drainage
|
Under G.A., pneumoperitoneum will be created
• Under direct visualization, abscess will be deroofed and drained completely, with placement of intra-abdominal drain
• Other structures will be visualized for any other findings, such as patchy caecal necrosis or intra-abdominal collections.
• Drain output monitoring will be done. |
| Comparator Agent |
USG guided Pigtail catheter drain Placement |
Patient laid supine, parts cleaned and draped.
• Site is marked using USG guidance.
• USG guided pigtail catheter inserted under local anesthesia and fixed to skin.
• Drain output monitoring will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Size >200ml on USG |
|
| ExclusionCriteria |
| Details |
• Pregnancy and lactation
• Shock
• Malignancy
• Recurrent abscess
• INR >2.0 at the time of intervention
• Ruptured/ impending rupture |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to drain removal |
Time to drain removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of hospital stay, recurrence of abscess, any other intra- operative findings (bile leakage, peritoneal spillage / abscess) number of ultrasound exams required. |
Duration of hospital stay, recurrence of abscess, any other intra- operative findings (bile leakage, peritoneal spillage / abscess) number of ultrasound exams required. |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Written and informed consent will be taken from the individual for participating in the study. All patients with liver abscess coming to Surgery OPD or emergency will be evaluated as per management of liver abscess. Ultrasound will be done in emergency; Routine investigations will be sent. All patients will receive medical therapy of double antibiotics as per recommendation. All patients fulfilling the inclusion and exclusion criterion will be allotted a computer generated random number which will be allocated by sealed envelope technique, all odd numbers will belong to Group-A and even numbers will belong to Group-B. Group-A (n=10)- Laparoscopic drainage with drain placement Group-B (n=10)- Percutaneous pigtail catheter drainage. PAC clearance will be obtained for patients planned for Laparoscopic drainage (Group-A) under G.A and advice will be followed. Drainage of abscess with either of the procedure will be performed within 48 hours of admission. Complications of the two procedures will be evaluated and treated accordingly. Criterion for drain removal will be applied, based on amount, character, clinical outcomes. Drain out Time will be noted (days for which drain will be placed) Duration of hospital stay will be studied from the time of admission to the time of discharge. Patient will be discharged who meet the discharge criterion - afebrile for at least 24 hours, orally accepting, free of drains and normal coagulation profile. Data will be entered in a proforma and analyzed for any statistical difference between duration of hospital stay and drain out time in patients undergoing either of the 2 procedures.
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