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CTRI Number  CTRI/2022/05/042834 [Registered on: 26/05/2022] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Effect of faster recovery protocol on outcomes of laparoscopic surgeries in children 
Scientific Title of Study   Impact of an enhanced recovery after surgery (ERAS) protocol on length of stay, perioperative outcomes and complications in paediatric laparoscopic surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Shah 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no.6, Porta Cabin, 4 th floor, Emergency building, A.I.I.M.S, New Delhi.

New Delhi
DELHI
110029
India 
Phone  09892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shreya Shah 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no.6, Porta Cabin, 4 th floor, Emergency building, A.I.I.M.S, New Delhi.

New Delhi
DELHI
110029
India 
Phone  09892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Shreya Shah 
Designation  Assistant Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no.6, Porta Cabin, 4 th floor, Emergency building, A.I.I.M.S., New Delhi.

New Delhi
DELHI
110029
India 
Phone  09892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Source of Monetary or Material Support  
Material support by Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi. Monetary support: Not Applicable 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi 
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreya Shah  All India Institute of Medical Sciences  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New Delhi 110029
South
DELHI 
09892652781

shreyabs@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Elements of ERAS protocol in all the 3 phases: preoperative, intraoperative and postoperative  The elements in the preoperative period will include risk assessment, detailed preoperative counselling, patient optimization, avoidance of prolonged fasting with preoperative carbohydrate loading, avoidance of mechanical bowel preparation and anxiolytic premedication. The intraoperative elements will include adequate analgesia (regional with minimal use of short acting opioids), antiemetic prophylaxis, antibiotic prophylaxis, maintainence of near zero fluid balance, maintenance of normothermia, adequate glycaemic control, thromboprophylaxis and avoidance of surgical drains, tube and catheters Postoperative elements will include early removal of nasogastric tube and urinary catheter (if placed), early diet advancement, near zero fluid balance, early postop mobilization, adequate analgesia (regional and nonnarcotic) observing pain scores and treatment of nausea and vomiting. Elements of ERAS protocol according to surgical and anaesthesia requirements 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  All paediatric patients, ASA grade I/II, undergoing various elective laparoscopic surgeries at our center who are eligible for the ERAS protocol 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the length of hospital stay   Patients will be assessed daily till discharge . Primary outcome being in days 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the perioperative complications (within 30-days)
2. To determine the incidence and reason for 30-day readmission
3. To determine the number of components of ERAS which could be followed and their effect on duration of hospital stay
 
One day prior to surgery to 30 days postoperative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/08/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Presently not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Today in the era of minimally invasive surgery, paediatric laparoscopy has become widely popular. The safety and efficacy of Enhanced recovery after surgery (ERAS) protocols in adult surgeries has been well established. There is particularly a limited data in the Indian scenario regarding the perioperative outcomes of paediatric patients undergoing surgeries with ERAS protocols. Therefore, this prospective study is being planned to determine the safety and feasibility of ERAS protocols in paediatric patients undergoing laparoscopic surgeries.

The study will be conducted in the Department of Anaesthesia, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi. The trial will be registered with the Central Trial Registry of India. Children between 2 to 14 years, ASA grade I/II satisfying the inclusion criteria scheduled for elective laparoscopic surgeries (thoracic and abdomino-perineal) will be recruited for the study. It will be a Prospective, single arm, feasibility study.

ERAS protocol elements will be applied in the three phases of perioperative period. The elements in the preoperative period will include risk assessment, detailed preoperative counselling, patient optimization, avoidance of prolonged fasting with preoperative carbohydrate loading, avoidance of mechanical bowel preparation and anxiolytic premedication. The intraoperative elements will include adequate analgesia (regional with minimal use of short acting opioids), antiemetic prophylaxis, antibiotic prophylaxis, maintainence of near zero fluid balance, maintenance of normothermia, adequate glycaemic control, thromboprophylaxis and avoidance of surgical drains, tube and catheters Postoperative elements will include early removal of nasogastric tube and urinary catheter (if placed), early diet advancement, near zero fluid balance, early postop mobilization, adequate analgesia (regional and nonnarcotic) observing pain scores and treatment of nausea and vomiting. Start time and duration of surgery will be noted. Laparoscopic surgery which gets converted to open will be excluded.

Discharge criteria will be followed strictly and a post discharge follow-up plan will be explained to the parents. All patients will be audited for compliance especially with the patient driven elements of the protocol. The number of protocol elements followed in each patient will be noted. The number of protocol elements not followed and the reasons thereof will also be documented. The rate of complications and the rate of readmissions will be noted. This study will recruit 30 patients initially and an interim analysis will be done to find the practices most likely to be followed and most likely leading to early discharge. The initial protocol will undergo necessary changes if needed and the next 30 patients will receive the modified ERAS protocol.

 
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