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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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