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CTRI Number  CTRI/2024/08/072331 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Study to look for the effect of ERAS protocol on stress response index in patient who underwent Radical Cholecystectomy 
Scientific Title of Study   Effect of enhanced recovery after surgery(ERAS) protocol on the stress response index in patient who underwent radical cholecystectomy with general anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soumya Sankar Nath 
Designation  Professor (JR Grade) 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Anesthesiology And CCM, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW

Lucknow
UTTAR PRADESH
226010
India 
Phone  9648935430  
Fax    
Email  soumyanath@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Soumya Sankar Nath 
Designation  Professor (JR Grade) 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Department of Anesthesiology and CCM, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  9648935430  
Fax    
Email  soumyanath@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishal Pandey 
Designation  Resident 
Affiliation  Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow 
Address  Dr S C Rai Hostel, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  8853048385  
Fax    
Email  pandey.vishal68@gmail.com  
 
Source of Monetary or Material Support  
Dr Ram Manohar Lohia Institute of Medical Sciences, Vibhuti khand, Gomtinagar, Lucknow, Uttar Pradesh,226010, India 
 
Primary Sponsor  
Name  Dr Ram Manohar Lohia Institute of Medical Sciences Lucknow 
Address  Vibhuti Khand, Gomati Nagar, Lucknow, 226010 
Type of Sponsor  Research institution and hospital 
 
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 Somya Sankar Nath  Dr Ram Manohar Lohia Institute of Medical Sciences  Department pf anaesthesiology and CCM
Lucknow
UTTAR PRADESH 
9648935430

soumyanath@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIECES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ERAS group  1.Via tablet proper education will be given to patients about anaesthetic & surgical procedure and patient’s record will be examined 2-Preoperative carbohydrate loading will be done 3-Intraoperatively balanced salt solution shall be administered at a @4ml/kg/hr 4-Higher Fi02 (60%) shall be administered intra-operatively 5-Postoperative discontinuation of IV fluid half an hour after surgery 6-Patients will be encouraged to move their limbs every 5 min and further allowed to recover in semi-recumbent position 7-No abdominal drain shall be left  
Comparator Agent  Non ERAS group  1-Patients records will be examined and all the procedure will be explained to the patients 2- Fasting advice 6 hours for solid food & milk and 2 hours for clear fluid prior to surgery 3-Intra operative and post operative fluid management will be done  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Adult patients between 18-70 years, of either gender, who are willing to consent for participation in the study

2. Patients with confirmed carcinoma of gall bladder without metastasis and posted for radical Cholecystectomy

3. American Society of Anesthesiologists (ASA) physical classes I and II.
 
 
ExclusionCriteria 
Details  1.Patient’s s refusal to give consent
2.Diabetes mellitus
3.Patient having gall bladder carcinoma but not advised radical cholecystectomy as plan of treatment
4.Patients with metastasis
5.Patients with any contraindication to insertion of epidural catheter, like patient’s refusal, coagulopathy, anatomical deformities of the spine, infection at the site of insertion.
6.Patient refused to cease smoking/ consume alcohol or ceased smoking/alcohol consumption for less than 4 weeks.
7.Intra-abdominal drain
8.Uncorrected anemia

 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.Enhanced rate of recovery in patients undergone Radical Cholecystectomy
2.Reducing the overall complication rates without affecting the readmission rates.
 
48 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Decrease hospital length of stay.
2.Decrease time of return bowel function
3.Predicting which agent & timing is ideal for preoperative venous thromboembolism prophylaxis
4.Getting to know about the ideal combination of medication & modalities for postoperative analgesia
5.Knowing about the optimal timing of urinary catheter removal
6.Preferred combination of antiemetics in the post operative period
7.Reducing cost for the patient’s treatment
8.Early mobilization of the patient
 
48 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/08/2024 
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 Yet Recruiting 
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  

The basic components of the ERAS protocol include pre-operative counselling to psychologically prepare the patient for the surgery, avoidance of fasting, preoperative nutrition including carbohydrate loading upto two hours prior to surgery, analgesic regimes including epidural and non-opioid analgesia, mobilization and resumption of enteral feeding. There is ample evidence that ERAS protocol hastens postoperative recovery leading to improved outcome, including early oral intake, early mobilization, shorter hospital stay and, thus, higher satisfaction among patients. Carbohydrate loading, suggested by ERAS protocol reduces the postoperative stress induced insulin resistance and also minimizes nitrogen and protein losses. It promotes faster recovery through faster return of bowel function, shorter length of hospital stays (LOS), and thus, better perioperative feeling of well-being.

ERAS protocol had been widely studied in laparoscopic cholecystectomies (LC). Yu Tianyang MM et al in a retrospective study on 126 patients reported that the ERAS group had significantly earlier time to first flatus, time to first ambulation, time to solid intake compared with the traditional group. Further, the ERAS group had significantly lower postoperative lung and abdominal cavity infection compared to the traditional group.Udayasankar M et al (2020) performed a prospective randomized controlled study in 50 patients reported lower anxiety prior to surgery and at 6 hours postoperatively. Hunger, thirst and fatigue were also decreased with better overall perioperative experience. Zhang N et al (2020) performed a retrospective analysis of 445 patients who underwent LC with biliary duct exploration and found that the WBC count and CRP levels were significantly lower among those who underwent LC with ERAS protocol than those without ERAS protocol one day after surgery. Flatus time, length of hospital stays after surgery, incidence of nausea, incisional pain and vomiting were lower in the ERAS group compared to the non-ERAS group. Nair A et al (2023) did a systematic review and meta-analysis and reported that the LOS, time to first flatus was found to be significantly shorter in the ERAS group than the control group, for both LC and LC with CBD exploration. Among patients who underwent LC, incidences of PONV and pain scores were lower in ERAS group compared to conventional group.

Among abdominal open surgeries, ERAS protocols have been studied in colo-rectal, vascular, thoracic and radical cystectomies surgeries.  but there is no report in literature, about the effects of ERAS protocols in radical cholecystectomies. ERAS society published the guidelines for perioperative care in elective abdominal and pelvic surgeries in LMIC in 2022 to improve the perioperative care and to promote data driven, evidence-based care.

Carcinoma of gall bladder (CaGB) is quite rampant in India and it accounts for 10% of the global case load of CaGB. It has a predilection for female gender and ranks among three top cancers among women of North and North-eastern India. The age standardized rate (ASR) for CaGB in women of North and north-east India are 11.8/100,000 population and 17.1/100,000 population, respectively.[9] Radical cholecystectomy with en bloc hepatic resection and regional lymph node resection, is the recommended method of managing non-metastatic CaGB.[10] Radical cholecystectomy is defined as the resection of the gallbladder and gallbladder fossa and is usually combined with a supraduodenal lymphadenectomy for the treatment of gallbladder cancer. The extent of the hepatic resection may include nonanatomic parenchymal resection of the gallbladder fossa to a standard segment IVb/V resection with data suggesting superior survival from segment IVb/V resection over standard cholecystectomy. The goal of the resection is complete resection of all histopathologic disease, which may necessitate resection of the common hepatic duct/common bile duct if clearance of all disease cannot be obtained by division at the cystic duct/common hepatic duct junction. 
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