| 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
|
|
|
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 |
|
|
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. |