| CTRI Number |
CTRI/2024/07/071296 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Comparing the post operative speedy recovery between conventional and fastrack method] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing postoperative recovery after pancreaticoduodenectomy surgery by conventional versus FAST TRACK protocol |
|
Scientific Title of Study
|
Fast Track Surgery in Whipples Procedure - 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 Amarnath G |
| Designation |
Mch Surgical Gastroenterology Resident |
| Affiliation |
Government Stanley Medical College |
| Address |
Room No 202, Block No 601 A, Institute of Surgical Gastroenterology and Liver Transplant, Government Stanley Medical College, 1, Old Jail Road, George town, Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9600337523 |
| Fax |
|
| Email |
doctorgamarnath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeswanth S |
| Designation |
Professor / Head of the Department, Surgical Gastroenterology |
| Affiliation |
Government Stanley Medical College |
| Address |
Block No 601 A, Institute of Surgical Gastroenterology and Liver Transplant, Government Stanley Medical College, 1, Old Jail Road, George Town, Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9444357682 |
| Fax |
|
| Email |
dr_jeswanth@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarnath G |
| Designation |
Mch Surgical Gastroenterology Resident |
| Affiliation |
Government Stanley Medical College |
| Address |
Room No 202, Block No 601 A, Institute of Surgical Gastroenterology and Liver Transplant, Government Stanley Medical College, 1, Old Jail Road, George Town, Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9600337523 |
| Fax |
|
| Email |
doctorgamarnath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Amarnath G,
Government stanley medical college, no 1, old jail road, George town, chennai 600001 |
|
|
Primary Sponsor
|
| Name |
Dr Amarnath G |
| Address |
601 A Block, Institute of Surgical Gastroenterology and Liver Transplant, Government Stanley Medical College, 1, Old Jail Road, George Town, Chennai 600001 |
| Type of Sponsor |
Other [Self] |
|
|
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 AmarnathG |
Government Stanley Medical College |
Room No 202, Block No 601 A, Institute of Surgical Gastroenterology and Liver Transplant, Government Stanley Medical College, 1, Old Jail Road, George Town, Chennai 600001
Chennai
TAMIL NADU |
9600337523
doctorgamarnath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Stanley Medical College and Hospital, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL METHOD |
POSTOP:
Intermittent intravenous analgesia
NG tube decompression till POD-5
Oral liquids from POD -6
Soft Diet from POD-7
No nausea & vomiting prophylaxis
No specific action on mobilization
No specific criteria for removal of foley’s catheter & abdominal drain
No specific criteria for discharge
|
| Intervention |
FAST TRACK METHOD |
Day 0: Iv fluids, NPO, Epidural analgesia (continuous infusion of bupivacaine 0.125% with fentanyl 2 microgram /ml at rate of 5ml /hr until day 5 ± iv para / NSAIDS
If epidural is contraindicated (analgesia with morphine + iv para / NSAIDS) given.
Day 1 - Removal of Nasogastric tube if 300 ml
Clear oral liquids
Mobilisation out of bed for 1 hour
Metoclopromide (60mg / day) started to reduce nausea & vomiting
Trickle feeding 20-30ml /hr through feeding jejunostomy
Day 2: Enhanced mobilization for 2 hours
Urinary catheters removed
FJ 50ml /hr
Day 3:
Liquid diet
Drain tube amylase checked
Removal of drainage tubes if no pancreatic or biliary fistula and
volume less than 200 ml
Mobilisation for 4 hours, personal hygiene care in bathroom
Day 4
Soft solid diet
Day 5 - Dietary increase on daily basis (5-6 small meals) until reaching a calorie intake of 1000 kcal on day -8
Epidural catheters removed
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing pancreaticoduodenectomy(lap/open) for either one of the following diagnosis during the study period in our SGE department
Carcinoma(ductal) head of pancreas
Periampullary carcinoma
Distal CBD growth
Duodenal carcinoma
Cystic neoplasm of pancreas head
Neuroendocrine tumour of pancreas head
Chronic calcific pancreatitis with head mass
|
|
| ExclusionCriteria |
| Details |
Consent not given by the patient
Locally advanced or distant metastasis (who undergo palliative bypass)
Having more than 2 co-morbidities
Pre operative systemic organ failure
ASA- IV / V
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fast track & conventional protocols are compared in Whipple’s surgery based on early Ryle’s tube removal, early orals, early mobilization, early removal of drainage tube, continuous epidural analgesics and the outcome will be measured |
2-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing the total hospital stay of patients followed up with conventional & fast track method in post operative whipples patients |
4-6 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/08/2024 |
| 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="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
|
The study will include only selected
patients who fit in our inclusion criteria & undergo pancreatico-duodenectomy at our Institute of Surgical
Gastroenterology & Liver Transplantation, Govt Stanley medical College
& Hospital.
A total of 44 lots, 22 for fast
track & 22 for conventional protocol will be kept in a container and
allowing patients to choose the follow up protocol under randomization at the
time of admission and will be followed accordingly.
Fast track will be considered as
study group and will be compared to control (conventional group)
The
purpose of the study will be explained to the subjects and a written informed
consent
will be
obtained
Preoperative parameters- detailed
demographic profile, clinical symptoms with duration, clinical findings, blood
investigations reports (complete blood counts, renal function tests with
electrolytes, blood sugar, liver function test), viral marker status (HBsAg,
Anti HCV), upper GI endoscopy, findings of radiological imaging (x ray chest,
usg abdomen with doppler, CECT abdomen / MRI abdomen & CA 19-9 values were
recorded.
After assessing operability,
classical pancreaticoduodenectomy to be done. Post operatively each patient will be followed according to the group alloted and recovery will be compared in each group. |