| CTRI Number |
CTRI/2019/02/017537 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
06/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
adapted enhanced recovery after surgery pathway vs. standard care in patients undergoing emergency laparotomy for perforation peritonitis- Which is better?
|
|
Scientific Title of Study
|
Comparison of adapted enhanced recovery after surgery pathway vs. standard care in patients undergoing emergency laparotomy for perforation peritonitis- A Randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranavi A R |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
dept of surgery, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903307190 |
| Fax |
|
| Email |
pranavi.ar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikram Kate |
| Designation |
Professor and HOD |
| Affiliation |
JIPMER |
| Address |
dept of surgery, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikram Kate |
| Designation |
Professor and HOD |
| Affiliation |
JIPMER |
| Address |
dept of surgery, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG thesis, funded by the Institute |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research Government of India |
| Address |
Dhanvantri Nagar Pondicherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranavi A R |
Jawaharlal Institute of Postgraduate Medical Education & Research, Government of India. |
Dept of surgery, JIPMER, Dhanvantari Nagar
Pondicherry
PONDICHERRY |
8903307190
pranavi.ar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K650||Generalized (acute) peritonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adapted ERAS pathway |
Adapted ERAS (Enhanced recovery after surgery) pathway will be applied to the study group |
| Comparator Agent |
Control Group |
standard treatment protocol of the unit |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients above 18 years of age, who present to
the emergency surgical team with perforation peritonitis,
diagnosed based on clinical examination and adjunct
investigations and planned for emergency laparotomy after
volume resuscitation. |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years
2. Uncontrolled comorbid diseases.
3. Localized peritonitis
4. American Society of Anesthesiologists physical status class 4E
5. Patients with coagulopathy (INR .1.5 and platelet count < 1 lakh)
6. Patients on vasopressor or ventilator support
7. Septic shock
8. Associated psychiatric or neurological illnesses
9. Pregnant patients
10. Polytrauma patients with associated other intraabdominal organ injury |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lenth of hospital stay |
from 4 days upto 2-3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify risk factors which are responsible for delayed discharge/ failure of
ERAS |
from 4 days upto 2-3 weeks |
Time elapsed until resumption of oral feeding
ï‚· Time for removal of nasogastric tube, drains and catheter
ï‚· Duration of ileus
ï‚· Need for extra analgesics
ï‚· Need for reinsertion of nasogastric tube
ï‚· Re-admission, re-operation and mortality rate
ï‚· Medical complications- pulmonary complications, acute renal failure and
urinary tract infections.
ï‚· Surgical complications- incidence of post-operative nausea and vomiting, SSI |
from 1 day upto 2-3 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
27/02/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Emergency laparotomies constitute majority of the emergency surgical operations amongst which surgeries done for small bowel pathologies account for 22 % to 33 % of the cases.Postoperative mortality rates of 10-14 % have been reported following emergency procedures for small bowel pathology in India.This indicates the dire need for revising the perioperative care practices in the emergency setting. Enhanced Recovery After Surgery (ERAS) pathway, is an integrated care pathway that utilizes multimodal evidence based approach to optimize patient’s recovery.The purpose of these pathways is to use current evidence in a streamlined multidisciplinary manner with the aim of minimizing surgical pain and enhancing recovery, leading to fewer complications, more rapid hospital discharge and improved overall outcomes. The applicability of ERAS pathways has been tested in numerous elective procedures but there is a dearth in the studies conducted in an emergency setting. Hence this study is planned to assess the feasibility of ERAS in patients undergoing emergency surgery for perforation peritonitis. |