| CTRI Number |
CTRI/2025/05/087183 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| 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 postoperative pain in low pressure
pneumoperitoneum versus standard pressure pneumoperitoneum in laparoscopic Intraperitoneal Onlay Mesh ( IPOM ) plus repair for midline ventral hernia
|
|
Scientific Title of Study
|
Comparison of postoperative pain in low pressure
pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum among patients undergoing laparoscopic Intraperitoneal Onlay Mesh ( IPOM ) plus repair for midline ventral hernia
|
| Trial Acronym |
IPOMplus+ |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aryan Gupta |
| Designation |
Junior Resident |
| Affiliation |
Department of Surgical Disciplines, All India Institute Of Medical Sciences Delhi, |
| Address |
Room 421, Surgery Office, Department of Surgical Disciplines, 4th floor, Surgery Block, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
aryan.k.sahu75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ankita singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences Delhi, |
| Address |
Room 411, 4th floor, Surgery Block , AIIMS, Ansari Nagar East, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
9968633846 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ankita singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Sciences Delhi, |
| Address |
Room 411, 4th floor, Surgery Block , AIIMS, Ansari Nagar East, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
9968633846 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 411, 4th floor, Surgical Disciplines, Surgery Block, Ansari Nagar East, All India Institute Of Medical Sciences, Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Delhi, address |
| Address |
Sri Aurobindo Marg, AIIMS, Ansari Nagar East, New Delhi, 110029
|
| 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 |
| Dr Aryan Gupta |
All India Institute Of Medical Sciences Delhi |
Room 411, 4th Floor, Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi-110029
New Delhi
DELHI |
6394231917
aryan.k.sahu75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ethics committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
low pressure pneumoperitoneum (8- 10 mm Hg) with Deep NEUROMUSCULAR BLOCKADE NMB in
IPOM(intraperitoneum onlay mesh repair) plus repair |
pain will be asses 6 and 24 hours after the procedure |
| Comparator Agent |
standard pressure pneumoperitoneum IPOM(intraperitoneum onlay mesh repair) plus repair |
pain will be asses 6 and 24 hours after the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-BMI - 18.5 - 35 kg/m?
WHO definition - ( normal, overweight , grade 1 obesity and grade 2 obesity )
- primary ventral hernia - umbilical type
W1 and W2 according to European hernia society classification
- patient is able to follow instruction |
|
| ExclusionCriteria |
| Details |
a) Unable to give consent or patient refusal.
b) Prolonged surgery due to intraoperative complications such as unexpected bleeding and hollow viscous injury.
c) Conversion to open surgery
d)Unfit for general anaesthesia
e)Pregnancy.
f)Need for additional port besides standard three port for IPOM Plus. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To asses and compare pain during the post operative period at 6 hours and 24 hours post-surgery in two groups A(low pressure pneumoperitoneum with deep neuromuscular blockade) and B (standard pressure pneumoperitoneum) |
Post operative period at 6 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Compare difficulty in performing surgery according to predefined surgical rating scale - likert scale in group A & B |
Immediately at the end of surgery |
| 2.Compare operative time( Skin incision to skin closure in minutes) in group A & B |
Immediately at the end of surgery |
| 3. Compare rise of inflammatory markers post operatively – CRP in group A & B |
24 hours post operatively |
| 4.Proportion of patients in which conversion to standard pressure pneumoperitoneum is required |
At the end of data collection i.e. 1 year 6months |
| 5.Compare need for conversion of intracoporeal to transfacial method, for closure of defect in group A & B |
Immediately at the end of surgery |
| 6.Compare need for additional analgesia( other than Paracetamol 10-15 mg/kg & diclofenac 1.5-2 mg/kg 1.5-2 mg/kg) in group A & B |
6hors & 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/05/2025 |
| 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="9"
Days="30" |
|
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 (Others) - on request
- What additional supporting information will be shared?
Response - Study Protocol
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - email ID of cheif guide
- For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2030?
Response (Others) - 5 years
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
The study is a single-institution prospective, randomised controlled non-inferiority trial conducted at the Department of Surgical Disciplines, AIMS, New Delhi. Sixty patients with primary ventral hernia (European Heria Society classification - umbilical hernia W1 and W2, defect size less than or equal to 4 cm) will be included, randomised into two groups of 35 each. Group A will undergo laparoscopic IPOM plus repair with low-pressure pneumoperitoneum (8-10 mmHg) and deep neuromuscular blockade (NMB), while Group B will undergo standard-pressure pneumoperitoneum (12-14 mmg). Randomisation will follow a computer-generated permuted block sequence (blocks of 10), sealed in envelopes. Patients will be blinded to the intervention, and pain scores
will be assessed postoperatively by blinded clinicians. Standard pre-operative workup includes blood tests (LFT, CBC, RFT, CRP, ESR, ete.), informed consent, and adherence to institutional anaesthetic protocols. During surgery, mesh fixation and defect closure will be performed laparoscopically by a skilled surgeon using a standardised approach. Post-operatively, blood markers will be reevaluated at 24 hours, and pain will be assessed using a visual analogue scale at 6 and 24 hours. Postoperative analgesia will be standardised across both groups. Data on operative outcomes, including inflammatory markers, pain, and complications, will be collected and analysed to compare the efficacy of the two techniques. |