| CTRI Number |
CTRI/2025/07/091460 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Laparoscopic Methods (TAPP and IPOM) for Repairing Hernias Around the Umbilicus: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparison of Transabdominal Preperitoneal (TAPP) and Intraperitoneal onlay mesh (IPOM) Repair For Primary Umbilical and Paraumbilical Hernia
- A Randomized Controlled Trial |
| 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 ANUBHAV VINDAL |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
department of surgery Second Floor, BL Taneja block, Maulana Azad Medical College and associated hospitals, delhi gate New Delhi
Central
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjan kumar L |
| Designation |
post graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
department of surgery Second Floor, BL Taneja block, Maulana Azad Medical College and associated hospitals, delhi gate New Delhi
Central
DELHI
110002
India |
| Phone |
8619002747 |
| Fax |
|
| Email |
dr.ranjanrxl5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANUBHAV VINDAL |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
department of surgery Second Floor, BL Taneja block, Maulana Azad Medical College and associated hospitals,delhi gate New Delhi
DELHI
110002
India |
| Phone |
9968604403 |
| Fax |
|
| Email |
anubhav.vindal@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of surgery second floor bl taneja block maulana azad medical college and associated lok nayak hospital delhi gate new delhi india -110002 |
|
|
Primary Sponsor
|
| Name |
Dr Anubhav Vindal |
| Address |
department of surgery Second Floor, BL Taneja block, Maulana Azad Medical College and associated hospitals, New Delhi india 110002 |
| 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 Anubhav Vindal |
Maulana Azad Medical College |
department of surgery Second Floor, BL Taneja block, Maulana Azad Medical College and associated lok nayak hospitals, New Delhi india 110002
Central
DELHI |
9968604403
anubhav.vindal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laparoscopic transabdominal preperitoneal (TAPP) repair with intraperitoneal onlay mesh (IPOM) repair |
laparoscopic transabdominal preperitoneal (TAPP) repair with intraperitoneal onlay mesh (IPOM) repair
duration is 3 month |
| Comparator Agent |
laparoscopic transabdominal preperitoneal (TAPP) repair with intraperitoneal onlay mesh (IPOM) repair |
laparoscopic transabdominal preperitoneal (TAPP) repair with intraperitoneal onlay mesh (IPOM) repair |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Defect size less than 4 cm (In maximum dimension on ultrasonography) |
|
| ExclusionCriteria |
| Details |
Complicated hernia (obstructed or strangulated)
Any other concomitant abdominal pathology requiring surgical intervention
BMI more than 35
Pregnancy
Lactation
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference in short term recurrence (defined as visible bulge or presence of cough impulse at the surgical site on ultrasonography at 3 months) |
3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean difference in duration of surgery (time in minutes from skin incision to skin closure)
Mean difference in postoperative pain (Visual analogue score)16 at 24 hours, 7 days & 30 days
Mean difference in duration of hospital stay (in days)
Mean difference in postoperative complications (Clavien Dindo classification)17 within 30 days
Mean difference in patient satisfaction at 30 days (Capuzzo score) |
24 hours, 7 days, 30 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
08/08/2025 |
| 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="0"
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
|
A hernia refers to the protrusion of an organ through the wall of the cavity that normally contains it, with ventral hernias specifically involving a defect in the anterior abdominal wall. These hernias are classified based on location—epigastric (near the upper abdomen), umbilical (at the navel), and hypogastric (below the navel). Various laparoscopic techniques are used for ventral hernia repair, including IPOM, TAPP, eTEP, SCOLA, and others. Among these, IPOM is widely used but is associated with complications like adhesions, fistulas, and chronic pain due to the mesh’s contact with internal organs. Newer methods like TAPP and eTEP aim to place the mesh outside the peritoneal cavity, minimizing contact with abdominal contents and reducing complications by positioning the mesh in the preperitoneal space. |