| CTRI Number |
CTRI/2024/10/075293 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ERAS PROTOCOL and conventional protocol in elective GI surgeries. |
|
Scientific Title of Study
|
Comparison of post operative recovery in patients undergoing Elective gastrointestinal surgeries with and without ERAS Protocol A Randomised Controlled Study |
| 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 Deepak kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 2A, Room No.202, Department of General Surgery, Maulana Azad Medical College, Near Bahadur Shah Zafar Marg, Daryaganj
New Delhi
DELHI
110002
India |
| Phone |
8700369665 |
| Fax |
|
| Email |
deepak9868kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Bhushan Singh |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 2A, Room No.201, Department of General Surgery, Maulana Azad Medical College, Near Bahadur Shah Zafar Marg, Daryaganj
New Delhi
DELHI
110002
India |
| Phone |
9717212602 |
| Fax |
|
| Email |
drchandrabhushansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak kumar |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 2A, Room No.202, Department of General Surgery, Maulana Azad Medical College, Near Bahadur Shah Zafar Marg, Daryaganj
New Delhi
DELHI
110002
India |
| Phone |
8700369665 |
| Fax |
|
| Email |
deepak9868kumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, Near Delhi Gate, Dariyaganj, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital, Bahadurshah Zafar Marg ,New Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrDeepak Kumar |
Maulana Azad Medical College |
Maulana Azad Medical College,Ward 2A,Department Of Surgery Bahadur Shah Zafar Marg, Near Delhi Gate, Dariyaganj, New Delhi,110002
New Delhi
DELHI |
8700369665
deepak9868kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional protocol |
1)Over night NPO
2)No preop carbohydrate loading
3)Bowel preparation
4)Opiod analgesics intraoperatively
5)NG tube insitu for atleast 24-48hours
6)Oral sips allowed after passing flatus
7)Removal of abdominal drain on POD 4-6
Total Duration approx 120hr.
|
| Intervention |
ERAS PROTOCOL |
1)Light meal upto 6hours and clear liquid upto 2 hours before induction of anaesthesia
2)Carbohydrate loading 2 hours before surgery
3)Antibiotic administration within 1 hour of incision
4)Opioid sparing analgesia
5)Early removal of NG tube
6)Oral liquids allowed on POD0 and soft diet on POD1
7)Early mobilization after OT.
Total duration approx 40Hrs
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients between 18 to 65 yr undergoing elective Gastrointestinal surgeries. |
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactation
Patients on chronic steroids intake
Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay (in days) |
On Post Operative Day 2 and Post Operative Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Time to pass first flatus in hours
2)Time to pass first stool in days
3) 30 days mortality
4) 30 days qquality of life |
1) On Post Operative Day 0
2) Post Operative Day 1
3) Post Operative Day 2
4) Post operative Day 30
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
27/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Traditionally the management of patients in the postoperative period requires keeping them nil per oral with gastric decompression using a nasogastric tube for the first few days. Once the patient passes flatus/faeces, oral feeding is started, first with liquids and then gradually built up to semisolid and solid diet. It was considered that withholding the feed in early postoperative period provides gastro intestinal tract adequate time to heal. Many recent studies and trials do not support this notion. It has been seen that early feeding following surgery is feasible, and may improve the post operative outcome of the patients with early return to activities of daily living, early discharge and very few postoperative complications .
ERAS programmes are evidenced-based protocols designed to standardize and optimize perioperative and postoperative care in order to reduce surgical trauma, perioperative physiological stress, morbidity, total cost and duration of stay in hospital. It was published initially for colorectal surgery in 2005, but now well established for many other surgical conditions. There is already substantial evidence in the literature demonstrating the effectiveness of adopting ERAS based protocols in elective surgery, resulting in a change of clinical approach. ERAS could benefit elective surgery patients due to its design to allowing early postoperative feed and return functional status more efficiently.The aim of our study is to compare elective gastrointestinal surgeries with and without Enhanced Recovery After Surgery(ERAS) Protocol. |