| CTRI Number |
CTRI/2024/09/073293 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
To study the implementation of fast track surgery guidelines in scheduled caesarean section and its effect on faster recovery of mothers during postoperative period in comparison with conventional care group in a tertiary care centre in South India
|
|
Scientific Title of Study
|
A randomised controlled trial to assess faster recovery of mothers by implementation of ERAS guidelines for scheduled caesarean section in comparison with the conventional care in a tertiary care centre in South India
|
| Trial Acronym |
ERAS Enhanced Recovery After Surgery |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmitha |
| Designation |
PG registar |
| Affiliation |
Christian medical college |
| Address |
OG 5 Office
Department of Obstetrics and Gynaecology
CMC vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8610766432 |
| Fax |
|
| Email |
Sushmithag96k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Annie Prasanthi |
| Designation |
Head of the department |
| Affiliation |
Christian medical college |
| Address |
Department of obstetrics and gynaecology
Chittoor campus
CMC Vellore
Vellore
TAMIL NADU
517002
India |
| Phone |
|
| Fax |
|
| Email |
annie.prasanthi@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sushmitha |
| Designation |
PG registar |
| Affiliation |
Christian medical college |
| Address |
og 5 office
Departmnet of obstetrics and gynaecology
CMC Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8610766432 |
| Fax |
|
| Email |
Sushmithag96k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid grant,Cmc vellore
pin code 632002
vellore
India |
|
|
Primary Sponsor
|
| Name |
Fluid Research grant |
| Address |
Cmc vellore
632002
Vellore
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sushmitha |
OG 5 OG 3 OG 4 Department of obstetrics and gynaecology Christian medical college |
CMC Vellore
632002
Vellore
India
Vellore
TAMIL NADU |
8610766432
Sushmithag96k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS protocol |
This protocol will be followed in the interventional group |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Female |
| Details |
Elective caesarean
Term pregnancy
Primigravida and Multigravida
|
|
| ExclusionCriteria |
| Details |
Unscheduled and emergency ceasarean section
Severe Preeclampsia, Eclampsia, cardiac disease, uncontrolled overt diabetes mellitus, autoimmune diseases
Intraoperative and postoperative complications requiring prolonged catheterization and hospital stay (postpartum hemorrhage, organ injuries, paralytic ileus, etc)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of surgery to time for fit to discharge. |
immediate postpartum
at 6 hours
day 1
day 2
day 3
OPD review after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time from surgery to first ambulation
Patient satisfaction in regards to pain relief and ambulation 3.Incidence of spinal headache
Incidence of voiding difficulties
Delay in bowel movement 6.Fever
Surgical site infection
Incidence of thrombo embolic events
Number of hospital readmissions |
Time of surgery to time for fit to discharge and followup of patients postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/09/2024 |
| 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)
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
Modification(s)
|
Enhanced Recovery After Surgery (ERAS) is a standardised, perioperative care program that now is used within multiple surgical disciplines that include colorectal, urologic, gynecologic, and hepatobiliary surgery. Hospital length of stay (LOS) for CD has large variations at the provider and facility level. Chronic postsurgical pain affects up to 11% of women 1 year later with nearly 10% having severe pain. ERAS aims to standardise the perioperative care of the peripartum patient and helps improve maternal and neonatal outcomes. It is a focussed pathway starting during the antenatal visits. Patients for scheduled Caesarean delivery must be educated and informed about the procedure and consent should be taken. We are planning on a double blinded study in a tertiary care centre in the implementation of Enhanced recovery after surgery guidelines for scheduled caesarean section in reducing the hospital stay in comparison with conventional care. Information sheet is given to the mothers planned for elective LSCS in the OPD. At the time of admission in the ward, the eligible mothers are chosen in respect to inclusion and exclusion criteria. After informed consent of the eligible mothers, mothers are recruited to either ERAS group or the conventional care group through block randomization. Protocol as described in methods section is followed in both the groups respectively. Details of mothers in both the groups are taken in the proforma. Final data is analysed to check primary and secondary outcome. Successful ERAS pathway implementation has the potential to improve patient care and health care delivery system
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