| CTRI Number |
CTRI/2025/03/081717 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Methods for Better Peri operative outcomes in treatment of Groin Hernia surgery A Study on Between Two Techniques |
|
Scientific Title of Study
|
To Compare the Perioperative outcomes of Trans Abdominal Pre-Peritoneal Repair Procedure (TAPP) Versus Lichtenstein Open Repair in Treatment of Primary Unilateral Inguinal Hernia in Male patients: A Randomised Control Trail in a Tertiary care Centre of Eastern Uttar Pradesh |
| 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 Budarapu Vishnu Vardhan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
7991902933 |
| Fax |
|
| Email |
vishnubudarapu9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukul Singh |
| Designation |
Associate Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9997343119 |
| Fax |
|
| Email |
singhmukul3911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Singh |
| Designation |
Associate Professor of Surgery |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9997343119 |
| Fax |
|
| Email |
singhmukul3911@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery
All India Institute of Medical Sciences Kunraghat Gorakhpur Uttar Pradesh Country India Pincode 273008
|
|
|
Primary Sponsor
|
| Name |
Dr Budarapu Vishnu Vardhan |
| Address |
Department of General Surgery
All India Institute of Medical Sciences Kunraghat Gorakhpur Uttar Pradesh Country India Pincode 273008
|
| 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 Budarapu Vishnu Vardhan |
All India Institute of Medical Sciences Gorakhpur |
Department of General Surgery
All India Institute of Medical Sciences Gorakhpur
Gorakhpur
Uttar Pradesh
273008
India
Gorakhpur
UTTAR PRADESH |
7991902933
vishnubudarapu9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee All India Institute of Medical Sciences Gorakhpur India |
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 |
| Comparator Agent |
Lichtenstein Open Repair in treatment of Primary Unilateral Inguinal Hernia |
Local/Spinal/General anesthesia is given. A 5-6cm skin incision from pubic tubercle to lateral given. Then External Oblique Aponeurosis is opened. Upper leaf is freed from underlying Internal Oblique Aponeurosis.
The anatomic cleavage between 2 layers is avascular and dissection can be done rapidly and atraumatically. High separation of these layers is useful as it visualizes iliohypogastric nerve. To explore the internal ring, for indirect hernia sacs, the cremasteric sheath incised longitudinally at level of deep ring. Complete striping and resection of cremasteric fibers is unnecessary and can result in direct exposure of nerves, resulting in chronic groin and testicular pain. Indirect hernia sacs are freed from the cord to a point beyond the neck of sac, they are transfixed at level of neck, ligated and cut.
A polypropylene mesh of 15x7.5cm is used. The medial corner of mesh is tailored to shape of tracing of footprint, with sharp lower angle to fit into angle between inguinal ligament and rectus sheath and upper wider angle to spread over rectus sheath. With cord retracted upward, the sharper corner of mesh secured to insertion of rectus sheath to the pubic tubercle overlapping it by 1 to 2 cm. Rest of the mesh is secured upper part of mesh to the reflected part of the inguinal ligament, lower part of mesh to the conjoint tendon. Frequency is Single surgical procedure per participant.Total duration of intervention includes the duration of surgery and postoperative follow up which is assessed during hospital stay, on day of discharge, on the day when patient revisit for suture removal, 90 days, 180 days after surgery.
|
| Intervention |
Trans Abdominal Pre-Peritoneal Repair in treatment of Primary Unilateral Inguinal Hernia |
General Anesthesia with muscle relaxant. Pneumoperitoneum is established. Reduce hernia into abdominal cavity by graded external compression. Peritoneal dissection: should be high enough to allow 2cm overlap to avoid exposing the edge of the mesh. The indirect hernia sac is reduced and separated from spermatic cord. If large indirect sacs cannot be completely reduced, the sac can be divided, and proximal end ligated and then divided distal to ligated sac. Final step is mesh positioning and fixation. A rolled polypropylene mesh is inserted through the 10mm port and placed horizontally covering Myo pectineal orifice. The mesh 12x15cm is then anchored with sutures (prolene 2-0) to coopers ligament and lateral to Inferior Epigastric Vessels high at the abdominal wall to avoid cutaneous nerves. Single point fixation of mesh is done. Then adequate hemostasis and closing of peritoneal flap is done. It is advisable to close the peritoneal flap with continuous absorbable sutures (Barbed vicryl / vicryl ) under direct vision. Fascia at umbilical port site closed, skin at two 5mm ports are closed. Frequency is Single surgical procedure per participant.Total duration of intervention includes the duration of surgery and postoperative follow up which is assessed during hospital stay, on day of discharge, on the day when patient revisit for suture removal, 90 days, 180 days after surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1.Primary unilateral inguinal hernia
2.Direct or Indirect hernia
3.Adult patients (Age more than 18 years and less than 60 years)
|
|
| ExclusionCriteria |
| Details |
1.Female gender
2.Age less than 18 Years and more than 60 Years
3.Recurrent inguinal hernia on same side
4.Concomitant another procedure of hernia
5.Bilateral inguinal hernia with repair on both sides.
6.Patients not willing to be part of the study or assigned group.
7.Hernias from other than inguinal region.
8.Patients with previous lower Abdominal surgery or Trauma that may complicate laparoscopic access
9.Complicated hernia: Patients with obstructed, strangulated, or incarcerated hernias requiring emergency surgery
10.Patients with previous history of Diabetes Mellitus.
11.Patients with severe cardio-pulmonary or systemic illness precluding general anaesthesia which is required for TAPP.
12.Morbid Obesity (BMI greater than or equal to 35, which may hinder laparoscopic access or increase surgical risks.
13.Anesthesia related post operative complications to be excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Operative time.
2.Duration of hospital stay.
3.Time to return to normal activities or work.
4.Incidence of seroma or hematoma or surgical site infections during hospital stay.
|
Operative time will be assessed intraoperatively
Duration of hospital stay will be assessed postoperatively on day 1 day 3 day 5 or further if prolonged stay. Time to return to normal activities will assessed on day 1 day 3 day 5 at the time when patient comes for suture removal or further if prolonged duration. Incidence of seroma or hematoma or surgical site infections during hospital stay will be assessed on day 1 day 3 and further if prolonged hospital stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the incidence ,severity of chronic pain
2.To evaluate the incidence of surgical site infections
|
Chronic pain assessed at 12 weeks ,24 weeks postoperatively since chronic pain is defined as lasting beyond 3 months that is 12 weeks. Surgical site infections assessed during hospital stay, at 12 weeks ,at 24 weeks postoperatively or any time postoperatively till 24 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/03/2025 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Inguinal hernias are among the most common surgical
conditions worldwide, with millions of procedures performed annually. The
choice of surgical technique significantly impacts patient outcomes making it a
critical area of research. Lichtenstein open mesh repair is considered the gold
standard for open repair. A laparoscopic repair Trans Abdominal Pre peritoneal
Repair offers potential advantages. Existing studies on Trans Abdominal Pre
peritoneal repair versus Lichtenstein repair are often limited by heterogenicity
small sample sizes and observational designs. A randomized controlled trial
ensures robust unbiased comparison of these techniques providing high quality
evidence to guide clinical practice. This study will be conducted at the
Department of General Surgery All India Institute of Medical Sciences Gorakhpur Uttar Pradesh India. This tertiary care centre is equipped with
advanced medical facilities and a high volume of surgical cases providing a
suitable environment for conducting a randomized controlled trial. The setting
ensures access to a diverse patient population undergoing hernia repair
allowing for robust data collection and analysis. This is a prospective single
blinded single centred randomized controlled trial designed to compare the
outcomes of Trans abdominal pre peritoneal repair procedure versus Lichtenstein
open repair. Participants will be patients visiting surgery out patient
department taking into account the inclusion and exclusion criteria. Patients
will be randomized into one of the two study groups, Group A Trans abdominal
pre peritoneal repair and Group B Lichtenstein open repair alternatively in
order of arrival in outpatient department. All the cases of both group A and
group B will be operated by surgeons with equivalent experience of minimum 5
years. Patient will be followed for 180 days. In this duration patient will be
assessed on day of discharge on the day when patient revisit for suture
removal, 90 days, 180 days after surgery. In addition patient will be assessed
in between if any complications arise. The key outcomes that will be assessed
include operative time duration of hospital stay time to return to normal
activities or work incidence of seroma hematoma surgical site infections
during hospital stay incidence and severity of chronic pain at 3 months and 6
months post operatively and surgical site infections at 6 months post
operatively in patients undergoing Trans abdominal pre peritoneal repair versus
Lichtenstein open repair. Then assessment of outcomes is done.
|