| CTRI Number |
CTRI/2021/05/033558 [Registered on: 11/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of routine care Vs assisted recovery based care in patients undergoing emergency abdominal surgery. |
|
Scientific Title of Study
|
Comparison of adapted Enhanced Recovery After Surgery (ERAS) pathway versus standard care in patients undergoing emergency abdominal surgery – 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 |
Dr Likhita S Singh |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of General Surgery,JIPMER Campus,Dhanvantri nagar,Gorimedu,Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9581565705 |
| Fax |
|
| Email |
likhitassingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of General Surgery,JIPMER Campus,Dhanvantri nagar,Gorimedu,Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Kate |
| Designation |
Professor (Senior Scale) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of General Surgery,JIPMER Campus,Dhanvantri nagar,Gorimedu,Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843058013 |
| Fax |
|
| Email |
drvikramkate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education And Research(JIPMER) |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education And Research JIPMER |
| Address |
Dhanvantri Nagar,Gorimedu,Puducherry-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 Likhita S Singh |
Jawaharlal Institute of Postgraduate Medical Education & Research, Government of India. |
Department of surgery, JIPMER, Dhanvantari Nagar,Gorimedu,
Pondicherry
Pondicherry
PONDICHERRY |
9581565705
likhitassingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
adapted ERAS protocol based care in emergency abdominal surgery |
-pre-operative counselling prior to surgery-pre operative fasting duration will be kept less than 6 hrs - -avoidance of fluid overload in participant pre op - Multimodal pre-operative non opioid analgesia-avoidance of the use of opioid analgesics intra op -avoidance of use of urinary catheter/drain/Ryles tube -early ambulation within 6 hrs post op -starting oral sips by 6 hrs post op and escalating it to oral clear liquids by 12 hrs and oral soft diet by 24 hr -. All the tubes and drains (nasogastric tube/foleys catheter/ abdominal drains) will be removed earlier than usual standard protocol. |
| Comparator Agent |
Standard protocol based care in emergency abdominal surgery. |
pre operatively patient is kept Nil by mouth for more than 6 hrs -fluid administration according to standard protocol of unit -Intra op analgesic and opioid use according to standard protocol of unit -use of urinary catheter/drain/Ryles tube based on discretion of operating surgeon -post op ambulation and resumption of feeds according to standard protocol of unit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients, who present to the emergency surgi-cal team for emergency abdominal surgery, diagnosed based on clinical examination and adjunct investigations and planned for emergency laparotomy after volume resuscitation. |
|
| ExclusionCriteria |
| Details |
1.Age<18 years
2.Uncontrolled comorbid diseases.
3.Localized peritonitis
4.Duodenal ulcer perforation
5.American Society of Anesthesiologists physical status class 4E
6.Patients with coagulopathy (INR more than 1.5 and platelet count < 1 lakh)
7.Patients on vasopressor or ventilator support
8.Septic shock
9.Associated psychiatric or neurological illnesses
10.Pregnant patients
11.Polytrauma patients with associated non abdominal in-juries.
12.Patients undergoing multi visceral resection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Length of hospitalization. |
4 days to 2-3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of ileus and time to first bowel sound |
6 hrs in ERAS (study) arm vs more than 6 hrs in Control arm |
| time to first fluid diet and first solid diet |
oral sips by 6 hrs and escalation to clear liquids by 12 hrs and liquid diet by 24 hrs in ERAS (study arm)
|
| Time of removal of urinary catheter |
when urine output is adequate for 24 hrs
from day 1 to 2-3 weeks |
| Time of nasogastric tube removal |
when the drain is less than 300ml/day
from 1 day to 2-3 weeks |
| Time of drain removal |
The abdominal drain, if any, will be withdrawn when the drainage is less than 100 ml/day irrespective of resumption of oral feeds.
from day 1 to 2-3 weeks |
| Time for mobilization |
day 1 to 2-3 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/05/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Bowel surgeries, particularly needing intestinal anastomosis have conventionally been managed by prolonged abstinence from oral intake, usage of opioid analgesics, insertion of nasogastric tube and urinary catheter etc.Enhanced Recovery After
Surgery (ERAS) pathway, is an integrated multidisciplinary pathway which
utilizes multimodal evidence-based approach to decrease perioperative surgical
stress, sustain postoperative physiological function and facilitate recovery in
surgical patients. 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.The ERAS pathway has
been successfully implemented and has been found to be safe and effective in
patients undergoing emergency small bowel surgeries and perforated duodenal
ulcer surgeries in our Institute.But there are very few
reports evaluating the role of ERAS in emergency laparotomies for all cases of
abdominal surgeries. Hence, this study is
being carried out to investigate the feasibility and efficacy of ERAS pathways
in patients undergoing emergency abdominal surgery.If found feasible and
safe with shorter length of hospitalization (LOH), the adapted ERAS pathway may be uniformly implemented in
all emergency abdominal surgeries. |