| CTRI Number |
CTRI/2024/04/065332 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Role of use of ERAS protocol in the pre operative, intraoperative and postoperative period in elective cesarean section for improvement of postoperative recovery |
|
Scientific Title of Study
|
ROLE OF ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IMPLEMENTATION IN PERIOPERATIVE CARE OF ELECTIVE CESAREAN SECTION FOR ENHANCEMENT OF POSTOPERATIVE RECOVERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Uday Beedkar |
| Designation |
junior Resident |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
Room no. G1 Radhikabai Hostel, Jawaharlal Nehru Medical College,Sawangi (Meghe), Datta Meghe Institute of higher education and research Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8805863892 |
| Fax |
|
| Email |
ashbthesis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neema Acharya |
| Designation |
Professor and Head |
| Affiliation |
DNB,DGO,PHD |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Sawangi (meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511838066 |
| Fax |
|
| Email |
neemasacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Uday Beedkar |
| Designation |
junior Resident |
| Affiliation |
Datta Meghe institute of higher education and research |
| Address |
Room no. G1, RAdhikabai Hostel, Jawaharlal Nehru Medical College,Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8805863892 |
| Fax |
|
| Email |
ashbeedkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher education and research |
| Address |
Datta Meghe Institute of higher education and research, Sawangi(meghe), Wardha-442001 |
| Type of Sponsor |
Private 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 |
| Dr Aishwarya Beedkar |
Acharya Vinoba Bhave Rural Hospital |
In patient department, Department of Obstetrics and Gynaecology, Acharya Vinoba Bhave Rural Hospital,Sawangi (Meghe)
Wardha
MAHARASHTRA |
8805863892
ashbthesis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients of elective lscs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enhanced Recovery After Surgery Protocols |
Evidence-based education given to the patient on antenatal visits
NBM for 8 hours prior to surgical time
Liberal fluid
Pain management:
Tramadol 2 U IV 12 hourly, Jonac suppository P/R TDS for days 1-3
Tablet Tramadol 50 MG BD on days 4-7
The urinary catheter removed at 72 hours
Ambulation on the next day
Feeding advanced as tolerated
IV access maintained for 3 days
Postoperative rehabilitation not monitored
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Uncomplicated pregnancies
2. Booked antenatal cases |
|
| ExclusionCriteria |
| Details |
1. Complicated Pregnancies
2. Unbooked Antenatal cases |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative ileus
Length of stay in hospital
Peak pain scores
Post-operative analgesic consumption
|
7 days post lscs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Re admission within 30 days
Surgical site infection
Post-partum hemorrhage
Deep Vein Thrombosis
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
30/04/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The Enhanced Recovery After Surgery (ERAS) program is a standardized protocol that includes perioperative care to reduce surgical stress. . In 1997 Henrik Kehlet introduced this concept. Since then, many advancements are being made through the foundation of the ERAS Society. Although there are studies showing improved outcomes, published data are confined to European and American settings. This may not apply to hospitals in India. Therefore, there is a need for a large, well-designed, and methodological study on this topic. Hence, we aim to conduct a study evaluating the impact of ERAS protocol implementation in women undergoing elective cesarean sections as compared to those undergoing elective cesarean sections with traditional protocol implementation. |