| CTRI Number |
CTRI/2022/05/042952 [Registered on: 31/05/2022] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| 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 enhanced recovery after surgery (ERAS) protocol vs. current standard hospital care in patients undergoing elective open ventral hernia repair. |
|
Scientific Title of Study
|
Comparison of enhanced recovery after surgery (ERAS) protocol vs. standard care in patients undergoing elective open ventral hernia repair-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 |
Diwash Koirala |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute Of Post-Graduate Medical Education & Research |
| Address |
Dept. of General Surgery
JIPMER
Dhanvantari Nagar, Pondicherry, 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843704284 |
| Fax |
|
| Email |
diwashkoirala18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar S |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Dept. of General Surgery
JIPMER
Dhanvantari Nagar, Pondicherry, 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788637893 |
| Fax |
|
| Email |
drsureshkumar08@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Kumar S |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Dept. of General Surgery
JIPMER
Dhanvantari Nagar, Pondicherry, 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788637893 |
| Fax |
|
| Email |
drsureshkumar08@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Dhanvantari Nagar
Pondicherry 605006
India |
| 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 |
| Diwash Koirala |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Dhanvantari Nagar
Pondicherry 605006
India
Pondicherry
PONDICHERRY |
9843704284
diwashkoirala18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ENHANCED RECOVERY AFTER SURGERY(ERAS) |
ERAS protocol will be followed and compared with current hospital practice in patients undergoing elective ventral hernia surgery and duration of length of hospitalization post surgery will be compared. 6 days with old hospital care vs 4 days with ERAS protocol.
|
| Comparator Agent |
Standard hospital care
|
Currently practicing standard hospital care will be followed and compared with that being done with ERAS protocol and duration of length of hospitalization post surgery will be compared
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted for elective open ventral hernia repair procedure requiring abdominal wall recon-struction (AWR) in the department of Surgery |
|
| ExclusionCriteria |
| Details |
1. Age<18 years.
2. ASA class 3 or 4
3. BMI>40kg/m2 , for non-diabetic patient; and BMI>30kg/m2 and HbA1C>8.0mg/dl, for diabetic patient
4. Minor ventral hernias (epigastric, parastomal and umbilical hernias, defect size <3 cm or repair without mesh placement)
5. Patients with planned bowel resection or stoma reversal
6. Patients with neurological and/or renal dis-orders, cardiac illnesses, bed ridden patients and patients on steroids
7. Patients unable to understand/respond to verbal or written commands
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient managed by ERAS protocol is expected to have shorter length of hospitalization.
|
4 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient managed by ERAS protocol is expected to have low postoperative complications, rapid return of bowel function, and readmission rates.
TO STUDY
• Duration of ileus and Time to first bowel sound (in days)
• Time to first flatus and first stool (in days)
• Time to first fluid diet and first solid diet (in days)
• Time of removal of urinary catheter (days)
• Need for extra analgesia—n (%)
• 30-day morbidity (Morbidity in terms of post-operative complications will be stratified using the Clavien- Dindo classification)
1 Number of patients who developed PONV (graded using the Apfel score)
2 Superficial and Deep incisional SSI (diagnosed according to CDC criteria)
3 Pulmonary complications (atelectasis, pleural effusion) diagnosed on Chest X-Ray.
4 Urinary tract infections (diagnosed by Urine Routine/Microscopy with Culture & Sensitivity)
5 Reoperation
• Mortality and readmission rates up to 30 days following surgery
|
30 DAYS
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/06/2022 |
| 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="4"
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)?
Response - NO
|
|
Brief Summary
|
Ventral hernias occur in the anterior abdominal wall and include most incisional hernias and Epigastric, Umbilical, Spigelian and Parastomal hernias. Open ventral hernia repair (VHR) is associated with prolonged hospitalization, postoperative complications and hospital readmissions. Giant ventral hernia repair is associated with a high risk of postoperative morbidity with delayed return of bowel function and prolonged length of hospitalization (LOH). Enhanced Recovery After Surgery is a multimodal, multidisciplinary approach to the care of the surgical patient. ERAS protocols have now become the standard of care in many procedures across specialties demonstrating a shorter hospital stay, reduced postoperative morbidity, rapid return of bowel function and reduced infections. Considering the longer hospital stay and associated morbidities in the ventral hernia repair, Implementation of ERAS may improve the outcome. The purpose of this study was to compare LOH for patients cared for with standard hospital protocols with patients cared for with an ERAS protocol. |