| CTRI Number |
CTRI/2017/11/010478 [Registered on: 14/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/08/2020 |
| 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 a different method of treatment (called "Enhanced Recovery After Surgery" or "ERAS") from traditional treatment to find out time taken for recovery after undergoing surgery for gastric cancer. |
|
Scientific Title of Study
|
Comparison of enhanced recovery after surgery versus conventional approach in gastric cancer - 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 |
Shritosh Kumar |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 307, PG-2 Hostel, AIIMS, SIjua
Khordha
ORISSA
751019
India |
| Phone |
9663595356 |
| Fax |
|
| Email |
shritosh30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushar Subhadarshan Mishra |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4th floor, Academic Block, AIIMS, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9438884251 |
| Fax |
|
| Email |
doctushar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shritosh Kumar |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 307, PG-2 Hostel, AIIMS, SIjua
Khordha
ORISSA
751019
India |
| Phone |
9663595356 |
| Fax |
|
| Email |
shritosh30@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Sijua, Patrapada, Bhubaneswar, Orissa |
| 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 |
| Shritosh Kumar |
All India Institute of Medical Sciences, Bhubaneswar |
Department of General Surgery, AIIMS, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA |
9663595356
shritosh30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, Patients diagnosed with carcinoma stomach, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional |
Under conventional group, patients fasted from midnight before the day of surgery.
A sedative premedication is usually given. Nasogastric tube is placed preoperatively and usually remained until flatus occurred and no gastric retention presented after operation. Intra-abdominal drains were placed during the surgery and in most cases they were maintained until the output was insignificant or till the day before discharge.
After the surgery, the patients were not allowed oral intake until flatus or obvious gastrointestinal movement occurred. The patients mobilized at their will and usually lay in bed for about two days after surgery.
The discharge criteria will be the same for both conventional and ERAS modality of treatment.
|
| Comparator Agent |
Enhanced Recovery After Surgery (ERAS) |
1. No preanesthetic medication.
2. Oral hydration solution 3 h before surgery.
3. Combination of epidural analgesia (TH7-11) and general anesthesia during surgery
4. Near 0 fluid balance; low threshold to begin Noradrenaline to keep MAP 60 mm hg
5. Short-acting anaesthetic drugs and short-acting muscle relaxants.
6. Titration of anaesthetic agents to be achieved using the BIS
7. Low-tidal volume ventilation.
8. Intraop warming
9. Perioperative DVT pumps
10. Perioperative 6th hr RBS control to keep 180mg% with insulin infusion.
11. Continuous thoracic epidural infusion of analgesics after surgery
12. Nonsteroidal anti-inflammatory drug intravenously after surgery thrice daily ( along with thoracic epidural- diclofenac 75mg iv ; Paracetamol 1 gm iv sos; only paracetamol if renal compromise)
13. Thoracic epidural follow-up in ward.
14. Removal of thoracic epidural on post op day 2 evening 5pm.
15. In ward, oral paracetamol 20mg /kg orally 6th-8th hrly for analgesics
16. Normal diet till evening on day before surgery folloed by complex carbohydrate drink at night.
17. Complex carbohydrate drink 3 hours before surgery.
18. No drain in distal gastrectomy, one or two drains in total gastrectomy.
19. NGT removed immediately after surgery.
20.Remove drain on POD 2
21. Encouraged to sit out of the bed for more than 6 hours on POD 1. Encourage to walk length of the ward on POD 2.
22.Drink water on POD 1, water and carbohydrate drink on POD 2. Liquid diet slowly upgraded to semi solid on POD 5 and solid on POD 7.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a) Histologically confirmed adenocarcinoma of stomach for which surgery is expected.
b) Patient age more than 18 years
c) Accepting solids or at least oral liquids
d) Eastern Cooperative Oncology Group performance status of 0, 1 or 2
e) American Society of Anesthesiologists score of I or II
f) No contraindication of epidural anesthesia
g) Written informed consent |
|
| ExclusionCriteria |
| Details |
a) Patients with uncontrolled diabetes or who needed the administration of insulin
b) Pregnancy
c) Involvement of duodenum |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative hospital stay. |
The patient will be assessed on post operative days 1,2,3,4,5,6,7,8,9,10 and further unless patient meets the discharge criteria. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of complications such as anastomotic leak, bowel obstruction, pneumonia, surgical site infection, mortality, reoperation and readmission |
30 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/09/2017 |
| Date of Study Completion (India) |
05/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gastric cancer is the fifth most common malignancy in the world and
third leading cause of cancer death in both sexes worldwide. A gastrectomy
with lymphadenectomy is the mainstay of treatment and perioperative
chemotherapy or chemoradiotherapy is administered in patients with advanced
disease. Gastric cancer was found to be the second most common cause of death
among all fatal cancers in both sexes aged 30-69 years in India. To minimize postoperative complications, the patients are kept fasting
from the night before surgery till variable periods after that, the bowel is
mechanically prepared, the patients are put on prolonged nasogatric
decompression, abdominal drains are put in for early detection of anastomotic
leakage, many of these being conventional than being objectively of benefit.
Enhanced recovery after surgery (ERAS) is an evidence based
multidisciplinary perioperative and postoperative care program, has dropped
many of the conventional approaches to get additional improvements in outcomes
such as decreased hospital stay, hospital cost without any increase in postoperative
complications. This approach has been successfully carried out around the
world for colorectal surgeries. ERAS has successfully been tried in patients
with gastric cancer but the series have been small. In patients with
gastric cancer, poor nutritional status pre operatively is common which may
interfere with healing and post operative outcome. Hence this study has been
planned to study the efficacy of ERAS protocol in such patients.
|