| CTRI Number |
CTRI/2025/11/096774 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A prospective comparative study of Enhanced Recovery After Surgery Protocol vs standard protocol of care in gynaecological surgeries |
|
Scientific Title of Study
|
A prospective comparative study of Enhanced Recovery After Surgery Protocol vs standard protocol of care in gynaecological surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kasturi Laxmi Maanasa |
| Designation |
Junior Resident |
| Affiliation |
BLDE (DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
BLDE (DU), Shri B M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura- 586103
Bijapur KARNATAKA 586103 India |
| Phone |
9491752467 |
| Fax |
|
| Email |
kasturilakshmimanasa@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kasturi Laxmi Maanasa |
| Designation |
Junior Resident |
| Affiliation |
BLDE (DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
BLDE (DU), Shri B M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura- 586103
Bijapur KARNATAKA 586103 India |
| Phone |
9491752467 |
| Fax |
|
| Email |
kasturilakshmimanasa@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Kasturi Laxmi Maanasa |
| Designation |
Junior Resident |
| Affiliation |
BLDE (DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
BLDE (DU), Shri B M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura- 586103
Bijapur KARNATAKA 586103 India |
| Phone |
9491752467 |
| Fax |
|
| Email |
kasturilakshmimanasa@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturi Laxmi Maanasa |
| Address |
BLDE (DU), Shri B M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura- 586103 |
| 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 Aruna M Biradar |
BLDE (DU), Shri B M Patil Medical College Hospital and Research Centre |
Room no 2, department of OBG, BLDE (DU), Shri B M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan Campus, Solapur Road, Vijayapura- 586103 Bijapur KARNATAKA |
8197191472
aruna.biradar@bldedu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, BLDE (DU), SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R398||Other symptoms and signs involvingthe genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS protocol |
Group A, that is, patients subjected to the ERAS protocol, will undergo a modified perioperative regimen, including a reduced preoperative fasting period. They will be administered with an oral carbohydrate drink (200 ml with 12 gms of carbohydrates) two hours prior to surgery and prophylactic antibiotics within 15-60 mins prior to surgery 6. Goal-directed intravenous fluid therapy, intraoperative use of non-opioid analgesics, early initiation of oral intake postoperatively, expedited postoperative mobilization, removal of catheter and duration of hospital stay. |
| Comparator Agent |
Standard protocol of care |
Group B, that is the standard protocol of care, entails fasting from midnight prior to surgery, that is, 6-8 hours, prophylactic antibiotics 60 mins prior to surgery, intravenous fluids administered as necessary, a combination of opioid and non-opioid analgesics intraoperatively, postoperatively oral intake is initiated after 12 hours or after bowel sounds are heard clearly. Catheter removal after 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Age more than 18 years
Abdominal hysterectomy
Regional anesthesia
Elective cases
|
|
| ExclusionCriteria |
| Details |
Untreated anemia
Bleeding disorders
Infections
Cardiopulmonary diseases
Gastrointestinal diseases
Suspected cases of malignancy
Severe neurological illnesses
Underlying diseases affecting the quality of life and nutritional condition
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate ERAS protocol implementation and its effect on recovery post-operation POST OPERATIVE DAY 0, 1, 2 |
To evaluate ERAS protocol implementation and its effect on recovery post-operation on post operative day 0,1,2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of ERAS protocol implementation on postoperative recovery, that is, early mobilization, return to normal feeding, duration of hospital stay & complication rates. |
1 day |
|
|
Target Sample Size
|
Total Sample Size="108" Sample Size from India="108"
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 1 |
|
Date of First Enrollment (India)
|
14/11/2025 |
| 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 - NO
|
|
Brief Summary
|
Hysterectomy
ranks among the most frequently conducted major surgical interventions in the
field of gynecology.
However, the availability of newer and less invasive
treatment choices for gynecological conditions has led to a decline in the
prevalence of total abdominal hysterectomy (TAH) with or without
salpingo-oophorectomy, particularly in developed countries.
The complexity of inpatient gynecologic surgeries
varies significantly from straightforward hysterectomies to intricate
cytoreductive cancer surgeries. Surgical
interventions create significant stress on the body, disrupting homeostasis and
triggering physiological changes. This
stress response leads to increased carbohydrate metabolism, elevated cardiac
output, and insulin resistance, potentially resulting in relative hypoxia,
impaired coagulation, and altered gastrointestinal and pulmonary function. These physiological disturbances can delay
recovery, prolong hospital stays and increase the risk of postoperative
complications. Extended hospitalization
directly contributes to higher health care costs and longer sick leave, which
adds to the overall socioeconomic burden. The primary objectives of
preoperative and postoperative protocols are to promote faster recovery,
minimize postoperative complications, and shorten hospital stays.
Kehlet
first introduced the Enhanced Recovery After Surgery (ERAS) protocol, which
represents a strategic approach aimed at optimizing perioperative care. The
ERAS protocol aims to achieve homeostasis, minimize surgical trauma, reduction
in inflammation and stress, and promote a faster recovery to baseline function
after surgery. The core principles of ERAS encompass preoperative counseling,
minimized perioperative fasting, prompt resumption of oral intake, and early
postoperative mobilization, opioid-sparing pain management, regional
anesthesia, minimally invasive surgical techniques, goal-directed IV fluid
management, and restricted usage of surgical drains and tubes. Studies have shown that implementing ERAS protocols
significantly reduces hospital length of stay and postoperative complications
across various surgical specialties, including Colo-rectal urologic and
gynecologic oncology, without raising the frequency of return to the healthcare system.
Thus, we have conducted this study to determine the
Efficacy and outcome of the ERAS protocol in comparison to the standard
protocol of care in major gynecological surgeries. |