| CTRI Number |
CTRI/2025/09/094274 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares two surgeries Trans Abdominal Pre-peritoneal (TAPP) and Enhanced view Totally Extraperitoneal Rives Stoppa (e-TEP RS) repair for Primary Umbilical and Para umbilical Hernia |
|
Scientific Title of Study
|
Comparison of Trans Abdominal Pre-peritoneal (TAPP) and Enhanced view Totally Extraperitoneal Rives Stoppa (e-TEP RS) repair for Primary Umbilical and Para umbilical Hernia – a Randomized Controlled 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 |
RAKSHITA |
| Designation |
Post graduate trainee |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 4A, Department of General Surgery, Lok Nayak Hospital, Jawaharlal Nehru Marg, New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9467238617 |
| Fax |
|
| Email |
rakrohan0110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJDEEP SINGH |
| Designation |
DIRECTOR PROFESSOR |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of General Surgery, Lok Nayak Hospital, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604383 |
| Fax |
|
| Email |
rajdeep.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAKSHITA |
| Designation |
Post graduate trainee |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 4A, Department of General Surgery, Lok Nayak Hospital, Jawaharlal Nehru Marg, New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9467238617 |
| Fax |
|
| Email |
rakrohan0110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Rakshita |
| Address |
Ward 4A, Department of General Surgery, Lok Nayak Hospital, Jawaharlal Nehru Marg, New Delhi, 110002 |
| 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 |
| Rakshita |
Lok Nayak Hospital |
Ward 4A, Department of General Surgery, Lok Nayak Hospital, Jawaharlal Nehru Marg, New Delhi, India
Central
DELHI |
9467238617
rakrohan0110@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: K429||Umbilical hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trans Abdominal Pre-peritoneal (TAPP) and Enhanced view Totally Extraperitoneal Rives Stoppa (e-TEP RS) repair for Primary Umbilical and Paraumbilical Hernia |
Two operative procedures will be compared |
| Comparator Agent |
Trans Abdominal Pre-peritoneal (TAPP) and Enhanced view Totally Extraperitoneal Rives Stoppa (e-TEP RS) repair for Primary Umbilical and Paraumbilical Hernia |
Two operative procedures will be compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 65 years
Defect size 1-4cm maximum transverse diameter, assessed clinically |
|
| ExclusionCriteria |
| Details |
Concurrent recuts diastasis of more than 2cm, measured at the umbilicus in supine position
Complicated hernia (obstructed or strangulated)
On anticoagulants other than aspirin
Obese patients (BMI of 35 or higher)
Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain (using Numerical Rating Scale) on day 1 and 10 after the procedure |
Post-operative pain (using Numerical Rating Scale) on day 1 and 10 after the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean operative time (time in minutes from skin incision to skin closure)
Proportion of patients with complications (seroma / hematoma formation, infection) within one month of surgery
Proportion of patients requiring conversion to another procedure
Mean inter-semilunar distance measured by ultrasound before surgery and at 4 weeks after procedure |
Mean operative time (time in minutes from skin incision to skin closure)
Proportion of patients with complications within one month of surgery
Mean inter-semilunar distance measured before surgery and at 4 weeks after procedure |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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
|
Ventral hernia of anterior abdominal wall is a common surgical problem due to any musculo-aponeurotic defect of anterolateral parietal abdominal wall through which protrusion of intra-abdominal or preperitoneal contents occurs. Midline primary hernias include epigastric, umbilical and paraumbilical hernias. Umbilical hernias occur due to conditions that cause stretching and thinning of the midline raphe (linea alba), such as in pregnancy, obesity, ascites and predisposes to reopening of umbilical defect. Paraumbilical hernias occur when a defect in linea alba is adjacent to the true umbilicus. In the current era, so many different options for the management of these hernias are available from various open to minimal invasive techniques, and these diversity of techniques makes the decision making more difficult in ventral hernias. The major advantage of laparoscopic hernia repair was the cosmetic benefit, early ambulation, less operative complications, less hospital stay, less blood loss and less chances of recurrence. The disadvantages of laparoscopic surgery included technical difficulty, use of general anesthesia and equipment cost. Minimal invasive procedures with different techniques and mesh positions have evolved rapidly in the last decade.The e-TEP technique is based on the principle that the extra peritoneal space can be created from almost anywhere in the anterior abdominal wall. Trans Abdominal Pre-Peritoneal technique involves the dissection of peritoneum off the posterior rectus sheath, with a mesh placed in the preperitoneal space. Both eTEP and TAPP are described in literature, but there is no direct comparison among the two techniques. Thus, this study will attempt to compare the short-term outcomes between eTEP and TAPP approaches to primary umbilical hernias and attempt to better define the indications for the two procedures. |