| CTRI Number |
CTRI/2024/07/071170 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effectiveness of Enhanced recovery after surgery versus conventional care in Emergency colorectal conditions |
|
Scientific Title of Study
|
Role of Enhanced recovery after surgery versus conventional care in Emergency colorectal surgeries A non inferior randomised 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 Riya Tyagi |
| Designation |
Junior resident |
| Affiliation |
Post Graduate Institute of Medical education and research, Chandigarh |
| Address |
Department of General surgery, 5th floor, B- block
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9650740485 |
| Fax |
|
| Email |
drriyatyagi03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Raj Sakaray |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical education and research, Chandigarh |
| Address |
Department of General Surgery, 5th floor, B- block
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7569838589 |
| Fax |
|
| Email |
sakaraypgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Tyagi |
| Designation |
Junior resident |
| Affiliation |
Post Graduate Institute of Medical education and research, Chandigarh |
| Address |
Department of General Surgery, 5th floor, B- block
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9650740485 |
| Fax |
|
| Email |
drriyatyagi03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, 5th floor, B- block, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Riya Tyagi |
| Address |
Department of General surgery, 5th floor, B-block, PGIMER, Chandigarh |
| 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 RIYA TYAGI |
Post Graduate Institute of medical education and research |
Department of General Surgery, 5th floor, B- block
Chandigarh
CHANDIGARH |
9650740485
drriyatyagi03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional care |
Routine peri operative care |
| Intervention |
Enhanced Recovery after surgery components- Pre operative, Intra operative and Post operative |
Pre operatively- Making patient and family understand the nature of the disease and planned procedure, Optimisation of Blood pressure, Blood sugars, Taking consultations from other departments like Cardiology for CAD and take appropriate clearances prior to surgery; Intra operative- Goal direct fluid therapy, Avoiding opioid analgesics, Avoiding drain placement, Minimally invasive surgery; Post operative- Removal of Ryle’s tube, catheters as early as possible, Early oral intake, Early ambulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hemodynamically stable patients
Patients diagnosed/suspected with colorectal cancers with acute abdomen (bleed, obstruction)
Patients with IBD requiring emergency surgery
Patients responding and maintaining resuscitation
Patient who will give consent |
|
| ExclusionCriteria |
| Details |
Patients not giving consent for study
Patients requiring ICU care for 24 hours or more
Patients requiring mechanical ventilation for 48 hours or more
Patients with persistent organ failure
Patients with colorectal perforation peritonitis
Pregnant patients
ASA 3 or more
Hemodynamically unstable patients requiring pressure support post operatively |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative length of stay |
Till patient discharged |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative complications
Readmission rates
Peri operative mortality
Initiation of 1st cycle of adjuvant chemotherapy (if needed) |
30 days post operatively
30 days post operatively
30 days post operatively
Till initiation of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A double blinded non inferiority randomised control trial that compares the effect of Modified Enhanced recovery after surgery protocol versus conventional care in Emergency colorectal conditions- obstruction/bleed to be conducted at Post Graduate Institute of medical education and research, India. The primary outcome will be Post operative length of stay. Secondary outcomes will be assessed after 30 days which would include- Post operative complications, Readmission rates, Peri operative mortality and Initiation of 1st cycle of adjuvant chemotherapy (if needed). |