| CTRI Number |
CTRI/2021/09/036527 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
13/09/2021 |
| 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 effects of early against conventional tube removal in decreasing the complications after pancreas and small intestine surgery |
|
Scientific Title of Study
|
Early versus Conventional drain removal in reducing the overall postoperative morbidity in patients undergoing Pancreatoduodenectomy - A Randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SREE SUBRAMANIYAN S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF GENERAL SURGERY
Old hospital
Building
JIPMER
Dhanvantari Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8015476825 |
| Fax |
|
| Email |
sssubramani96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJ KUMAR NAGARAJAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF GENERAL SURGERY
Old hospital
Building
JIPMER
Dhanvantari Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443292979 |
| Fax |
|
| Email |
raj.jipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJ KUMAR NAGARAJAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JIPMER |
| Address |
DEPARTMENT OF GENERAL SURGERY
Old hospital
Building
JIPMER
Dhanvantari Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443292979 |
| Fax |
|
| Email |
raj.jipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal institute of postgraduate medical education and research,
Dhanvantari Nagar, Puduchherry 605006, India |
| 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 |
| DR SREE SUBRAMANIYAN S |
JIPMER |
Dept Of General surgery Office,Second Floor, Institute
Block, Gorimedu,
Puducherry-605006
Pondicherry
PONDICHERRY |
8015476825
sssubramani96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients drain removed according to treating surgeon’s discretion |
After assessing the drain fluid amylase and if the patients are within the study criteria- Patients drain will be removed according to treating surgeon’s discretion (conventional group) |
| Intervention |
Patients drain removed on POD 3 (early drain removal group)
|
After assessing the drain fluid amylase and if the patients are within the study criteria- Patients drain will be removed on POD 3 {post operative day- 3} (early drain removal group) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients who undergo Pancreatoduodenectomy with drain fluid amylase on POD 1 (<5000IU/L) and POD 3 (<350IU/L) in the department of General Surgery and Surgical Gastroenterology JIPMER |
|
| ExclusionCriteria |
| Details |
1. Less than 18 years
2. Early Post Pancreatectomy haemorrhage [Defined as onset <24 h after the end of the index operation)
3. Re-laparotomy within 72 hours from index operation
4. Sinister appearance of drain effluent (pancreatic juice)
5. Clinical suspect of biliary fistula
6. Peripancreatic fluid collection > 5cm (max diameter) at a routine transabdominal USG before randomization.
7. Surgeons decision for keeping the drain (>POD3) in study group for whatever reasons.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the length of hospital stay (LOS) between the early drain removal and conventional drain removal group in patients undergoing pancreatoduodenectomy. |
To compare the length of hospital stay (LOS) by assessing on day 3, 10 and 30 (if not discharged) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) To compare the Pancreatic fistula rates among two groups
ii) To compare the rate of Intra abdominal collections among two groups
iii) To compare the Delayed gastric emptying rate among two groups
iv) To compare the rate of Gastrointestinal bleeding among two groups.
|
i) To compare the Pancreatic fistula by day 10 and day 30 ( if not discharged)
ii) To compare the rate of Intra abdominal collections by day 10 and day 30 ( if not discharged)
iii) To compare the Delayed gastric emptying rate by day 10 and day 30 ( if not discharged)
iv) To compare the rate of Gastrointestinal bleeding by day 10 and day 30 ( if not discharged)
|
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All
consecutive patients who undergo minimally invasive or open
pancreatoduodenectomy with drain fluid amylase on POD 1 (<5000IU/L) and POD
3 (<350IU/L) in the Department of Surgery and Surgical gastroenterology will
be included in the study. Drain will be placed intraoperatively for all
patients at the end of the procedure. After obtaining informed consent,
eligible patients are randomized into two groups on POD 3 by a computer
generated allocation schedule to receive either early or conventional drain removal. In both the groups, drain fluid amylase
levels are assessed on POD 1 and day 3. In Group 1 drain will be removed
according to treating surgeons discretion whereas in group 2, the drain will be
removed on POD 3 after ruling out intra-abdominal collection by ultrasound. Hospital stay, Pancreatic fistula, Intra abdominal
collections, Delayed gastric emptying, Gastrointestinal bleeding will be
analyzed in both the groups. |