| CTRI Number |
CTRI/2025/03/081661 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhanced recovery after surgery in patients with perforated duodenal ulcer |
|
Scientific Title of Study
|
ENHANCED RECOVERY AFTER SURGERY (ERAS) VS STANDARD PROTOCOL IN PEPTIC PRFORATION: A STUDY IN TERTIARY CARE CENTRE OF SOUTHERN ODISHA |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Biswajita Rautaray |
| Designation |
Post Graduate Resident |
| Affiliation |
Mkcg medical college |
| Address |
Department of General Surgery
Mkcg medical college
Berhampur
Odisha
760004
Ganjam
ORISSA
760004
India |
| Phone |
7978183406 |
| Fax |
|
| Email |
Rautaraybiswajita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. R R Mund |
| Designation |
Associate Professor |
| Affiliation |
Mkcg medical college |
| Address |
Department of General Surgery
Mkcg medical college
Berhampur
Odisha
760004
ORISSA
760004
India |
| Phone |
7978183406 |
| Fax |
|
| Email |
christinasetzhoff@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Biswajita Rautaray |
| Designation |
Post Graduate Resident |
| Affiliation |
Mkcg medical college |
| Address |
Department of General Surgery
Mkcg medical college
Berhampur
Odisha
760004
ORISSA
760004
India |
| Phone |
7978183406 |
| Fax |
|
| Email |
Rautaraybiswajita@gmail.com |
|
|
Source of Monetary or Material Support
|
| MKCG MEDICAL COLLEGE AND HOSPITAL, Berhampur
Ganjam. Odisha.
India. 760004 |
|
|
Primary Sponsor
|
| Name |
Mkcg medical college |
| Address |
Berhampur, Ganjam
Odisha. 760004 |
| Type of Sponsor |
Government medical college |
|
|
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 Biswajita Rautaray |
MKCG MEDICAL COLLEGE AND HOSPITAL |
Department of General Surgery
MKCG medical college
Berhampur
Ganjam
ORISSA |
7978183406
Rautaraybiswajita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICS COMMITTEE , MKCG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K261||Acute duodenal ulcer with perforation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS PROTOCOL |
Non opiod multimodal analgesia ,paracetamol 1gm iv tds as analgesic
Ambulation encouraged soon after effects of GA wanes off
Naso gastric tube removed soon after surgery after aspirating gastric contents
Urinary catheter removed on pod 0 soon after patient
ambulates
Feed: oral sips on day 1, liqid in next 12 hours. Semisolid on day 2, solid diet on day 3 or as and when toelrated by patient.
Subhepatic drain removed after 48 hours if the content is not bilious or purulent
|
| Comparator Agent |
Standard protocol |
Opiod analgesic ( tramadol 100mg im bd) amd converted to oral when patient tolerated solid feed.
Ambulation : as per patients own comfort
Removal of catheter after patient mobilizes
Removal of subhepatic drain: output 300ml/day and patient tolerates solid food for 24 hours
Naso gastric tube removal: output 300ml/day with resolution of ileus
Feed: oral sips after passing flatus. Liquid in next 24 hours. Semisolid diet after passing stool. Solid diet as and when patient tolerates.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Peptic perforation (duodenal) |
|
| ExclusionCriteria |
| Details |
Perforation Size more than 1cm
Shock at time of presentation
Ckd or cld patient
Pregnancy
Multiple perforations
Malignant perforation
Sealed perforation
Chronic steroid abuse
Patient requiring long term catheterization for other indication
Patient requiring post op ventilatory support for more than 12 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF STAY. |
No of days in hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
FUNCTIONAL RECOVERY PARAMETERS AND MORBIDITY.
1.Recovery of functional parameters (time of withdrawal of NG tube, time to first flatus, stool, fluid diet, Solid diet, reappearance of bowel sound, time to removal of foleys catheter and drains, time to ambulation.)
Post operative complications ( Pneumonia, post-operative nausea and vomiting, Ileus, Burst abdomen, Surgical site infection, Mortality)
|
Days after surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/03/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
•ERAS
protocols, are based on an evidence based modification of peri operative care
elements focusing on reduced
physiological and psychological stress.
This
study aims at evaluating the effectiveness,
feasibility and safety of
ERAS protocols in patients undergoing emergency laparotomy for perforated duodenal ulcers |