| CTRI Number |
CTRI/2019/09/021282 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
16/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE THE CLINICAL OUTCOME OF FAST TRACK PROTOCOLS AND CONVENTIONAL PROTOCOLS ON PATIENTS UNDERGOING EMERGENCY LAPAROTOMIES- A RANDOMIZED STUDY |
|
Scientific Title of Study
|
Enhanced Recovery After Surgery(ERAS) Protocols Versus Conventional Care Protocols Following Emergency Laparotomy: A Randomized Double Blinded Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Sharma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room no. 035505,5th floor, Department of General Surgery AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8860314670 |
| Fax |
|
| Email |
js130193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room no 016303, 6th floor Department of General Surgery, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9760755163 |
| Fax |
|
| Email |
surgeon_navin@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Sharma |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room no 035505, Department of General Surgery,5th floor, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8860314670 |
| Fax |
|
| Email |
js130193@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 014405,Department of General Surgery, AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
Jyoti Sharma |
| Address |
Room no 413, PG Girls Hostel, AIIMS Rishikesh |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Jyoti Sharma |
AIIMS Rishikesh |
Department of General Surgery AIIMS Rishikesh
Dehradun
UTTARANCHAL |
8860314670
js130193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional care protocols |
The patients in this group will be kept on Conventional care protocols fololowed prioperatively in surgical patients like removal of NG tube after bowel sounds come, orally allowed after passage of flatus, etc. and will be compared with the interventional group for differences in the length of stay, and peri operative morbidity and mortality. |
| Intervention |
ERAS protocols |
The patients under this category undergoing laparotomies will be kept on ERAS protocols perioperatively to compare the effects on length of stay and peri operative morbidity and mortality. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age >18 years with pre operatively diagnosed perforation peritonitis and acute intestinal obstruction planned for emergency laparotomies.
2. ASA grade Ie to IIIe
3. Hemodynamically stable
4. Patients giving Informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant patients.
2.Patients on chronic steroids.
3.Spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair.
4.Malignant ulcers confirmed by histopathological examination if biopsied for a high index of suspicion for malignancy.
5.Laparoscopic surgeries.
6.Acute abdominal trauma surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The length of hospital stay.
2.Morbidity and mortality during the first 30 days after surgery |
1.The length of hospital stay.
2.Morbidity and mortality during the first 30 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The time elapsed until the resumption of oral feeding, the need for nasogastric tube reinsertion, the need for extra analgesics, the readmission rate, and the reoperation rate. |
30 days |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2019 |
| 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="0"
Months="9"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective double blinded study is being undertaken to compare the clinical outcomes of application of ERAS protocols and conventional care protocols on patients undergoing Emergency Laparotomies for Acute Intestinal perforations and Acute Intestinal Obstructions. Our aim is to
investigate the feasibility and beneficial effects of Enhanced recovery after
surgery in the setting of emergency laparotomy. The primary outcomes are to
compare the surgical outcome in terms of post operative
complications,mortality, length of stay and re admission rate in patients with
acute abdomen undergoing emergency laparotomy with ERAS protocols and those with conventional post operative
care. The secondary objectives are to
evaluate the applicability,safety and effectiveness of ERAS in emergency
surgeries and to
standardise and optimise peri operative care in order to reduce surgical
trauma,peri operative physiological stress and organ dysfunction. The patients will be randomly divided into
two groups using a computer generated allocation software(Random Allocation
Software)and allocation concealment will be done by a sealed envelope to
prevent prior knowledge of treatment assignment. The numbers will be assigned
in strict chronological sequence and study participants will be entered in the
sequence. Each study patient will be allocated a unique randomization number on
successful completion of screening, to be assigned to receive either one of the
groups. The patients will be assessed post
operatively for complications, mortality,length of stay and readmission rate.
The patients will be followed up till 30 days post operatively. The primary endpoints will be the
length of hospital stay and morbidity and mortality during the first 30 days
after surgery. Morbidities will include superficial
and organ/space-type SSIs, postoperative ileus, pulmonary complications
including atelectasis and pleural
effusion and postoperative bleeding. The secondary endpoints will be the time elapsed until the
resumption of oral feeding, the need for nasogastric tube reinsertion, the need
for extra analgesics, the readmission rate, and the reoperation rate.
|