NCT07067281

Brief Summary

This study is comperative study between TAPP And Lichtenstein Techniques for Inguinal Hernia surgery.The Lichtenstein tension-free open hernioplasty involves placing a tailored polypropylene mesh over the inguinal canal defect, secured to ligament and oblique fascia under local/regional anesthesia.Transabdominal Preperitoneal (TAPP) hernia repair uses laparoscopic access via three ports (umbilicus and bilateral midclavicular lines), incises and closes a peritoneal flap, and places a large mesh in the preperitoneal space. Compression between these two procedure in terms of intraoperative ,postoperative complications and Long term follow up for recurrence of Hernia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 5, 2025

Last Update Submit

July 5, 2025

Conditions

Keywords

Trans abdominal preperitoneal repairOperative timeSurgical site infectionRecurrenceSeromaMesh infection

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Total duration of surgery in minutes, measure skin incision to reversal of pneumoperitoneum

    Intraoperative (measure during surgical procedure on day1)

Secondary Outcomes (3)

  • Postoperative ileus

    Up to 5 days

  • Surgical site infection

    Up to 30 days post operation

  • Hospital stay

    From date of surgery untill discharge , assessed upto 14days

Study Arms (2)

Lichtenstein Techniques for Inguinal Hernia surgery using as conventional method

ACTIVE COMPARATOR

Participants randomized to this arm will undergo open Lichtenstein tension-free mesh repair for inguinal hernia under regional (spinal) or local anesthesia. A standard polypropylene mesh will be placed over the inguinal canal posterior wall and fixed to the inguinal ligament and conjoint tendon using non-absorbable sutures. The procedure is performed through a single inguinal incision. Patients will receive perioperative analgesia and standard postoperative care. This technique serves as the control group, reflecting conventional open hernia repair.

Procedure: Lichtenstein Tension-Free Mesh Hernioplasty

TAPP Repair

EXPERIMENTAL

Participants in this arm will undergo laparoscopic Transabdominal Preperitoneal (TAPP) repair of inguinal hernia under general anesthesia. A standard 3-port laparoscopic technique will be used. After accessing the preperitoneal space, a large polypropylene mesh will be placed to cover the myopectineal orifice and fixed using tacks or glue. The peritoneal flap will be closed using absorbable sutures or staplers. Patients will receive standard laparoscopic postoperative care. This arm represents the minimally invasive surgical option.

Procedure: Laparoscopic Transabdominal Preperitoneal (TAPP) Repair

Interventions

Open surgical repair of inguinal hernia using a tension-free mesh technique. A standard polypropylene mesh is placed over the posterior wall of the inguinal canal and fixed with non-absorbable sutures under spinal or local anesthesia. This is a conventional method widely used in open hernia surgery.

Lichtenstein Techniques for Inguinal Hernia surgery using as conventional method

Laparoscopic approach to inguinal hernia repair performed under general anesthesia. Three ports are used to access the abdominal cavity, and a peritoneal flap is created to place a large polypropylene mesh in the preperitoneal space. The mesh is fixed with tacks or glue, and the peritoneal flap is closed. This minimally invasive method is designed to reduce postoperative pain and enhance recovery.

TAPP Repair

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganesh Shankar vidhyapthi Memorial Medical college kanpur

Kanpur, Uttar Pradesh, 208002, India

Location

MeSH Terms

Conditions

Hernia, InguinalSurgical Wound InfectionRecurrenceSeroma

Interventions

tetra-4-amidinophenoxypropaneWound Healing

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesDisease AttributesInflammation

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Shubham Chaubey, Principle investigator, MBBS

    GSVM MEDICAL COLLEGE KANPUR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized parallel Group,Active trial with computer generated randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident, Department of General Surgery

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 16, 2025

Study Start

April 1, 2024

Primary Completion

July 15, 2025

Study Completion

August 15, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified individual participants( IPD ) related to operative time, hospital stay and post operative complications

Shared Documents
CSR
Time Frame
6 months after publication of results for 2 years
Access Criteria
Qualifed researchers upon reasonable request

Locations