NCT07108972

Brief Summary

This study is dedicated to compare between 2 different techniques is the management of inguinal hernia repair using laparoscopic intervention and how it may affect the patients life style covering both benefits and possible adverse affects for each method

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 May 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

May 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 23, 2025

Last Update Submit

July 30, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Persisting pain

    a specific questionnaire will be used to assess the extent and nature of pain post-operative

    post-operatively up to 8 weeks

  • Hernia recurrence

    post-operatively up to 6 months

Secondary Outcomes (3)

  • Duration of operation (min)

    Baseline

  • Length of hospital stay (Days)

    up to 2 weeks

  • Time to return to usual activities (Days)

    Post-operatively up to 8 weeks

Study Arms (2)

TAPP Group

ACTIVE COMPARATOR
Procedure: Transabdominal pre-peritoneal laparoscopic inguinal hernia repair

TEP Group

ACTIVE COMPARATOR
Procedure: Totally extraperitoneal laparoscopic inguinal hernia repair

Interventions

laparoscopic inguinal hernia repair surgical technique that it's main principal is placing the mesh pre-peritoneally through transabdominal approach

TAPP Group

laparoscopic inguinal hernia repair surgical technique that it's main principal is placing the mesh pre-peritoneally through extraperitoneal approach

TEP Group

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- All patients with inguinal hernias (direct and indirect ؛pubonocele type/funicular type؛) with age between 15 to 60 years and any sex at the period between May 2024 to May 2025 presented electively to the outpatient clinic of the department of General surgery, Sohag University Hospital

You may not qualify if:

  • Patients with age below 15 years and more than 60 years.
  • Patients with mega hernias or complete indirect inguinal hernia.
  • Patients with obstructed or strangulated inguinal hernia.
  • Patients with abdominal malignancy \& cirrhosis with end stage liver disease.
  • Pregnancy or planning to become pregnant.
  • History of forced hernial reduction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Sohag Governorate, 82511, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 7, 2025

Study Start

May 1, 2024

Primary Completion

May 1, 2025

Study Completion

December 1, 2025

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations