| CTRI Number |
CTRI/2024/04/066409 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ERAS protocol versus conventional postoperative care in elective lower gastrointestinal surgeries to compare the outcomes and benefits in Recovery |
|
Scientific Title of Study
|
Enhanced recovery after surgery versus conventional postoperative care in elective lower gastrointestinal surgeries-A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lokesh |
| Designation |
Post graduate |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Aarupadai veedu medical College and hospital and research institute
Kirumampakkam
Puducherry
Department of General surgery
C block
Aarupadai veedu medical College and hospital and research institute
Kirumampakkam
Puducherry
Department of General surgery
C block
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9489463725 |
| Fax |
|
| Email |
lokeshshanmugam25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhivannan |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Aarupadai veedu medical College and hospital and research institute
Kirumampakkam
Puducherry -607402
India
Department of General surgery
C block
Aarupadai veedu medical College and hospital and research institute
Kirumampakkam
Puducherry -607402
Department of General surgery
C block
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443159777 |
| Fax |
|
| Email |
madhivanan.sundararajan@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhivannan |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Aarupadai veedu medical College and hospital and research institute
Puducherry-607402
India
Department of General surgery
C block
Aarupadai veedu medical College and hospital and research institute
Puducherry puducherry-607402
Department of General surgery
C block
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443159777 |
| Fax |
|
| Email |
madhivanan.sundararajan@avmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college hospital and research institute
Kirumampakkam
Puducherry-607402
India |
|
|
Primary Sponsor
|
| Name |
Lokesh |
| Address |
aarupadai veedu medical college and hospital and research institute
Kirumampakkam
Puducherry-607402
India |
| 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 |
| DrLokesh |
C Block Dept of General surgery |
C block
Department of General surgery Aarupadai veedu medical College and hospital and research institute
Kirumampakkam
Puducherry-607402
Pondicherry
PONDICHERRY |
9489463725
lokeshshanmugam25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Avmc Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional postoperative care |
PRE OPERATIVE PREPARATION
Liquid diet for 3 days
Mechanical enema
Fasting for 8 hrs before surgery
Drink deprivation 4 hrs before surgery
Nasogastric tube insertion
No pre operative antibiotics
ANAESTHESIA AND PAIN CONTROL
General anaesthesia and IV/IM Analgesia upon patient request.
POSTOPERATIVE MANAGEMENT
Routine drain tube placement
Liquid diet intake after recovery of bowel movement |
| Intervention |
Enhanced recovery after surgery |
Pre-Operative period
Pre-admission education
Intraoperative period
Active warming
Post operative period
Early oral nutrition
Early discharge planning
Opioid sparing technique
Early ambulation
Reduced fasting duration
Surgical techniques
Early catheter removal
Carbohydrate loading
Avoidance of prophylactic NG tubes and drains
Use of chewing gum
No/selective bowel preparation
Defined discharge criteria
Venous Thromboembolism prophylaxis
Goal directed peri-operative fluid management
Antibiotic prophylaxis
Pain and nausea management
Pre-Warming
Incentive spirometry |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age 20 to 70 years of age |
|
| ExclusionCriteria |
| Details |
Re laparotomy patients
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fast return of bowel motility
2.Decreased morbidity
3.Faster recovery |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased hospital stay
Decreased infection rate |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 29-11-2023 and end date provided 31-05-2024?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Enhanced recovery after surgery versus conventional postoperative care in elective lower gastrointestinal Surgeries
CONVENTIONAL PRE OPERATIVE PREPARATION Liquid diet for 3 days
Mechanical enema
Fasting for 8 hrs before surgery
Drink deprivation 4 hrs before surgery
Nasogastric tube insertion
No pre operative antibiotics ANAESTHESIA AND PAIN CONTROL General anaesthesia and IV/IM Analgesia upon patient request. POSTOPERATIVE MANAGEMENT Routine drain tube placement
Liquid diet intake after recovery of bowel movement
ERAS Oral purgatives No mechanical enema Normal meal until 6 hrs before surgery Normal carbohydrate drink(clear liquid) until 2 hrs before surgery No nasogastric tube insertion Prophylactic antibiotics administration for 3 days Thoracic epidural and catheter based intermittent boluses No routine drainage tube placement Water allowed 6 hrs postoperative period and liquid diet followed by transitional diet the next day
|