| CTRI Number |
CTRI/2022/03/041346 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study effect of ERAS protocol in improving outcome in patients undergoing surgery for stomach cancer |
|
Scientific Title of Study
|
Effect of Enhanced Recovery After Surgery (ERAS) protocol with respiratory prehabilitation on postoperative recovery and inflammatory and immune response in patients undergoing elective gastrectomy– 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 |
SRIRAM V S |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Junior Resident, Department of Surgery, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9633245335 |
| Fax |
|
| Email |
sriramvs1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRIRAM V S |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Junior Resident, Department of Surgery, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9633245335 |
| Fax |
|
| Email |
sriramvs1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRIRAM V S |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Puducherry |
| Address |
Junior Resident, Department of Surgery, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9633245335 |
| Fax |
|
| Email |
sriramvs1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
SRIRAM V S |
| Address |
Junior Resident, Department of Surgery, JIPMER, Puducherry |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Suresh Kumar |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Surgery
Pondicherry
PONDICHERRY |
9788637893
Drsureshkumar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Intervention studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS PROTOCOL |
Preoperative, intraoperative and post operative management of patients will be as per ERAS guidelines as mentioned in protocol.
Duration of therapy- for length of hospital stay |
| Comparator Agent |
Standard protocol |
Existing institutional guidelines for pre operative, intraoperative and post operative care will be followed
Duration of therapy- length of hospital stay |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients admitted for elective gastrectomy procedure in the department of Surgery |
|
| ExclusionCriteria |
| Details |
Age < 18 years or > 75 years
ASA (American Society of Anesthesiologists) physical status more than III
Conditions that make cooperation with ERAS programme impossible (e.g. Mental disorder, paralysis)
Severe organ dysfunction (heart, brain, hepatic or renal)
Patients with diabetes who require High insulin therapy for uncontrolled diabetes/ Severe malnutrition
Distant metastases necessitating resection of other organs
Patients who cannot perform the prescribed respiratory prehabilitation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Length of hospitalization- from the day of admission to the day of discharge
Length of postoperative hospital stay- measured from day of surgery to day of discharge.
|
date of admission
date of surgery
date of discharge from hospital
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulmonary complications (atelectasis, pleural effusion) |
every 24 hours in the postoperative period and at discharge
|
1.Serum albumin and prealbumin
2.C reactive protein
3.Neutrophil count
4.IL8, IL10
5.TNF-alpha
6.Serum LDH
7.IgG/IgM |
Measured at admission and postoperative day 3 and 7 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/04/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single centered, randomized control trial studying the effect of Enhanced Recovery After Surgery protocol in patients of gastric cancer undergoing elective gastrectomy. The primary outcome of the study will be length of Hospitalization and secondary outcomes will be occurrence of post operative pulmonary complications, and to compare immunological an inflammatory indices of the two study groups |