| CTRI Number |
CTRI/2025/02/080143 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
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Comparing Three Surgical Techniques for Inguinal Hernia: Traditional Open Lichtenstein Repair vs Two Keyhole Techniques with Mesh Placement [Laparoscopic Transabdominal Preperitoneal Repair (TAPP) and Laparoscopic Total Extraperitoneal Repair (TEP)] – A Study in a Nagpur Hospital"
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Scientific Title of Study
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Randomized Controlled Trial of Laparoscopic Transabdominal Preperitoneal Repair (TAPP) versus Laparoscopic Total Extraperitoneal Repair (TEP) versus Lichtenstein Open Repair for inguinal hernia in a tertiary care hospital in Nagpur
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| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Keshav Mittal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences,Napur |
| Address |
Room No.202, OPD Building, Department of General Surgery, All India Institute of Medical Sciences,Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7357955000 |
| Fax |
|
| Email |
mittalkeshav8a@gmal.com |
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Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Siddharth P Dubhashi |
| Designation |
Professor And Head |
| Affiliation |
All India Institute Of Medical Sciences, Nagpur |
| Address |
Room No.207, OPD Building, Department Of General Surgery, All India Institute Of Medical Sciences, Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9881624422 |
| Fax |
|
| Email |
spdubhashi@aiimsnagpur.edu.in |
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Details of Contact Person
Public Query
|
| Name |
Keshav Mittal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences,Nagpur |
| Address |
Room No.202, OPD Building, Department of General Surgery, All India Institute o Medical Sciences, Mihan, Dahegaon, Nagpur
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7357955000 |
| Fax |
|
| Email |
mittalkeshav8a@gmail.com |
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Source of Monetary or Material Support
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| All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur.PINCODE:441108 |
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Primary Sponsor
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| Name |
Dr Keshav Mittal |
| Address |
Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur.
PINCODE: 441108 |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Keshav Mittal |
All India Institute of Medical Sciences,Nagpur |
Room no 202,Department of General Surgery
Nagpur
MAHARASHTRA |
7357955000
mittalkeshav8a@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Laparoscopic Total Extraperitoneal Repair (TEP) |
The patient will be positioned supine on the operating table. Under General anaesthesia, Make a 10mm transverse Infraumbilical Incision. Expose the anterior rectus sheath and make a transverse incision to one side of midline to avoid inadvertent opening of peritoneum. Hold the margins of incised sheath with Vicryl 1-0 suture. Retrace the rectus muscle laterally and by finger dissection a space is created between the rectus muscle and posterior rectus sheath. Introduce a 10mm Hassan’s cannula (blunt tip cannula) into the preperitoneal space through the infraumbilical incision. Attach the insufflation tube to cannula and begin insufflation. Introduce a 10mm 30 telescope through sub umbilical port and and visualize the preperitoneal space. Place other two working ports, a 5mm port 2-3cm above the pubic symphysis in midline and a second 5/10mm port place in midline between two placed ports (Supraumbilical and Suprapubic). Identify the first landmark/ the reference point ,i.e. the pubic bone which appears as white glistening surface in midline. Bare the pubic bone from all connective tissue to create a shelf extending 2-3cm in retropubic space which acts as a shelf to place the mesh. Then trace the dissection laterally towards the side of hernia and do the lysis of adhesions or reduce the hernia as in direct hernia , the anatomical landmark now visible are Cooper’s ligament, iliopubic tract, femoral canal and the inferior epigastric vessels. Completely dissect off the cord structure and reduce the defect. In case of complete hernia, attempt should not be made to completely reduce but transect and ligate the sac and leave the distal sac insitu. Continue the dissection lateral to cord structure to create adequate space for placement of mesh. The anterior superior iliac spine marks the lateral boundary of the dissection. After creating the lateral space adequately, introduced the mesh through the 10mm supraumbilical port. Place the mesh over the space created so that it covers the site of hernia. Secure the mesh is place with the help of Tackers or by sutures. Now deflate the preperitoneal space and close the ports. |
| Intervention |
Laparoscopic Transabdominal Preperitoneal Repair (TAPP) |
Patient is positioned supine on the operating table, and general anesthesia is administered. An incision is made in the supraumbilical region to access the abdominal cavity. Three trocars are inserted: a 10mm trocar for the camera is placed in the supraumbilical region close to the umbilicus, while two 5mm working ports are positioned at the same level as the camera, just lateral to the rectus muscle. Pneumoperitoneum is created using a closed or open/semi-open technique by insufflating the abdomen with carbon dioxide gas to create a working space.The abdominal cavity is explored to identify the hernia defect and its contents. The peritoneum is incised to expose the preperitoneal space, which is dissected to reveal the hernia sac and defect. The hernia sac is freed from surrounding structures and reduced back into the abdominal cavity. A Polypropylene or composite partially absorbable mesh (15x15 cm) is used, which can be trimmed appropriately to fit the curve of the lateral incision. The mesh is inserted into the preperitoneal space and positioned to cover the hernia defect with adequate overlap. It is fixed using tackers or Polypropylene sutures. After securing the mesh, the peritoneum is sutured with Vicryl 2-0 RB. Finally, the abdomen is desufflated, and the ports are closed. |
| Comparator Agent |
Open Tension Free Lichtenstein Inguinal Hernia Repair |
An inguinal incision is made, starting medially at the pubic tubercle and extending laterally beyond the deep inguinal ring, 2 cm above and parallel to the inguinal ligament. The two layers of subcutaneous tissue (Superficial fascia of Camper and deeper fascia of Scarpa) are incised in the same line. A nick is made in the external oblique aponeurosis (EOA), which is then incised medially to divide the superficial inguinal ring, and laterally beyond the deep inguinal ring. The EOA is dissected upward to expose the conjoint tendon and downward to expose the inguinal ligament. The spermatic cord, along with the hernial sac, is dissected between fingers using a gauze piece and lifted from the fascia transversalis. In indirect inguinal hernia, the hernial sac lies anterolateral to the cord, covered by the cremasteric muscle and internal spermatic fascia. In direct inguinal hernia, the sac lies posteromedial to the cord structures.The cremasteric muscle and fascia are incised, followed by the internal spermatic fascia. The hernial sac is identified by a shiny white margin and dissected from the cord structures. The sac is opened at the fundus, and its contents are reduced into the peritoneal cavity. A standard 15cm x 7.5cm mesh is required. The lateral end of the mesh is split to accommodate the spermatic cord. The lower margin of mesh is fixed to the inguinal ligament, extending laterally beyond the deep inguinal ring using 2-0 polypropylene sutures. The mesh is sutured medially to the lateral border of the rectus sheath, above to the conjoint tendon.The split lateral end of the mesh is resutured beyond the spermatic cord. The external oblique aponeurosis is sutured with 2-0 Vicryl to create a new superficial inguinal ring. Finally, the skin is closed using 3-0 Ethilon sutures. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
-Pts aged more than 18years
-Unilateral or Bilateral hernia |
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| ExclusionCriteria |
| Details |
-Recurrent inguinal hernia
-Obstructed hernia
-Strangulated hernia
-Irreducible Inguinal hernia
-Patients below 18 years age
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1) Intra Operative Length Of Surgery
2) Post Operative Pain
3) Length Of Hospital stay
4)Wound Infection- SSI, Seroma, Hematoma, Pain or tenderness
5) Return to normal activities after surgery
6) Quality of Life using 36-item Short form survey (SF-36) |
1) Intra Operative Length Of surgery
2) Day 1,3 and 7
3) Length Of Hospital Stay
4) Day 1,3 and 7
5) Return to normal acivities after surgery
6) At 1 month, 3 month, 6 month and 1 year |
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Secondary Outcome
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| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
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Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
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17/02/2025 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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An inguinal hernia is a defect in the endo-abdominal fascia of sufficient size to allow escape of intraperitoneal or pre-peritoneal contents into the groin. Inguinal hernias usually present as a lump, with or without some discomfort, which may limit daily activities and the ability to work. They can occasionally be life-threatening if the bowel strangulates or becomes obstructed. The definitive treatment of inguinal hernia is surgery. The open Lichtenstein mesh repair of inguinal hernia has become a standard for inguinal hernia repair but the introduction of laparoscopic techniques have shown acceptable results in a number of literature. The different surgeries performed are:1) Laparoscopic Trans Abdominal Preperitoneal Repair (TAPP):: Laparoscopic treatment procedure , in which hernia repair and mesh placement will be between the peritoneal layers. 2) Laparoscopic Total Extraperitoneal Repair (TEP):: Laparoscopic treatment procedure , in which hernia repair and mesh placement will be entirely outside the peritoneum , and cavity won’t be breached. 3) Open Lichtenstein mesh repair: Open treatment procedure , with larger scar There are very few studies comparing laparoscopic inguinal hernioplasty with tension free open mesh hernia repair and, moreover, with Lichtenstein repair. Therefore, this study aims to to evaluate and compare the safety and efficacy of Laparoscopic (TAPP AND TEP) versus Open Repair among patients with clinically or radiologically proven Inguinal Hernia |