| CTRI Number |
CTRI/2025/11/097160 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if a new recovery method (ERAS) helps patients recover faster and better compared to traditional care after keyhole surgery for groin hernia at AIIMS Deoghar |
|
Scientific Title of Study
|
Evaluating the efficacy of enhanced recovery after surgery(eras) protocols in laparoscopic groin hernia repair-An open label prospective randomized study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHAVESH JIYANI |
| Designation |
Junior Resident |
| Affiliation |
AIIMS deoghar |
| Address |
Office Address 3rd floor D block
Department of General surgery
AIIMS Deoghar 814152
Deoghar
JHARKHAND
814152
India |
| Phone |
7568097900 |
| Fax |
|
| Email |
jiyanibhavesh3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amardeep Kumar |
| Designation |
Associate professor |
| Affiliation |
AIIMS Deoghar |
| Address |
eMail ID - rajamar82@gmail.com
Office Address3rd floor D block
Department of General surgery
AIIMS Deoghar 814152
Deoghar
JHARKHAND
814152
India |
| Phone |
8920891044 |
| Fax |
|
| Email |
rajamar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amardeep Kumar |
| Designation |
Associate professor |
| Affiliation |
AIIMS Deoghar |
| Address |
eMail ID - rajamar82@gmail.com
Office Address3rd floor D block
Department of General surgery
AIIMS Deoghar 814152
Deoghar
JHARKHAND
814152
India |
| Phone |
8920891044 |
| Fax |
|
| Email |
rajamar82@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3rd Floor, D block.
Department of General Surgery.
AIIMS Deoghar, Jharkhand, India.
Pin - 814152
|
|
|
Primary Sponsor
|
| Name |
Department of General Surgery AIIMS Deoghar |
| Address |
Office Address3rd floor D block
Department of General surgery
AIIMS Deoghar Jharkhand India 814152 |
| 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 Bhavesh Jiyani |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES DEOGHAR |
3rd floor, D block.
Department of General Surgery.
AIIMS Deoghar, Jharkhand, India.
Pin - 814152
Deoghar
JHARKHAND |
7568097900
jiyanibhavesh3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The5th IEC full committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: K419||Unilateral femoral hernia, withoutobstruction or gangrene, (4) ICD-10 Condition: K412||Bilateral femoral hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional (Group B): |
Peri-operative workup of the patient:
1Fasting Longer fasting periods-Fasting after yesterday night dinner
2Antimicrobial Prophylaxis
3Limited Preoperative Education
Intra-operative procedure
1General Anesthesia: Standard use of general anesthesia, with opioid and non opioid based analgesia.
2Fluid Management: Standard fluid administration
3 Opioid Use
4LAPROSCOPIC TECHNIQUE
Post-operative care of the patient will be as per standard.
1Delayed Mobilization
2Delayed Oral Intake
|
| Comparator Agent |
Conventional Care Group(Group B) |
Standard preoperative fasting
Routine anesthesia
Postoperative care as per surgeon’s discretion (e.g., delayed feeding, delayed/variable mobilization, opioid-based analgesia) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years– 70 years with unilateral or bilateral groin hernia (inguinal or femoral).
2. Planned elective laparoscopic TAPP or TEP repair.
3. American Society of Anesthesiologists (ASA) grade I or II.
4. Willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Emergency hernia repair (e.g., strangulated hernia)..
2. ASA grade III or higher.
3. Contraindications to laparoscopy (e.g., severe cardiopulmonary disease).
4. Chronic opioid use or pain syndromes.
5. Combined Procedure (e.g., Lap Cholecystectomy with TAPP/TEP)
6. Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare postopera1ve pain
scores between ERAS and
conven1onal care groups
2. To assess the length of hospital stay in
both groups.
|
1.Postoperative Pain: Measured using the
Visual Analog Scale (VAS, 0–10) at 0, 6, 12, 24, and 48 hours and after 1 week, after 4 week and 12 week post-surgery
2. Length of Hospital Stay: Time from surgery( to discharge (hours).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the time to return to normal activities/work(work, daily tasks)
2To compare complication rates (e.g., seroma, hematoma, infection, recurrence) between groups.
3To measure patient satisfaction post-surgery
4To measure patient’s quality of life
|
1. To evaluate the time to return to normal activities/work(work, daily tasks)
Time Points: Calculated in days when the patient regains full activities or rejoins work post-surgery.
2To compare complication rates (e.g., seroma, hematoma, infection, recurrence) between groups.
Time Points: At 1st week, 1 month, and 3 months after discharge.
3To measure patient satisfaction post-surgery
Time Points: At the time of discharge, 1st week, 1 month, and 3 months after discharge.
Tool: Surgical Satisfaction Questionnaire (SSQ-8).
4To measure patient’s quality of life
Time Points: Before surgery, at the time of discharge, 1st week, 1 month, and 3 months after discharge.
Tool: EuraHS-QoL validated questionnaire. |
|
|
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)
|
25/11/2025 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jiyanibhavesh3@gmail.com].
- For how long will this data be available start date provided 03-12-2025 and end date provided 03-08-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This
thesis titled “Evaluating the Efficacy of Enhanced Recovery After Surgery
(ERAS) Protocols in Laparoscopic Groin Hernia Repair: An Open Label Prospective
Randomized Study” is a prospective randomized controlled trial conducted at
AIIMS Deoghar. It aims to compare ERAS protocols with conventional
perioperative care in 100 patients (50 per group) undergoing laparoscopic groin
hernia repair (TAPP/TEP).
The
ERAS group will receive preoperative counseling, carbohydrate loading,
minimal fasting, optimized anesthesia, early oral intake, early mobilization,
and multimodal analgesia with minimal opioid use. The conventional care
group will follow standard practices including prolonged fasting,
opioid-based analgesia, and delayed mobilization/feeding.
Primary
outcomes:
postoperative pain scores and length of hospital stay.
Secondary outcomes: time to return to normal activities, complication
rates, readmissions, patient satisfaction, and quality of life (EuraHS-QoL).
The
study expects ERAS to reduce pain, shorten hospital stay by 4–6 hours,
accelerate recovery by 2–3 days, maintain or lower complication rates, and
improve overall patient satisfaction. Findings will provide evidence for
integrating ERAS into routine laparoscopic groin hernia repair.
|