NCT06514859

Brief Summary

The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

June 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 23, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

July 17, 2024

Last Update Submit

July 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence in management of inguinal hernia

    Rate of recurrence in both open and laparoscopic repair of inguinal hernia

    6 months after operation

Study Arms (2)

Laparoscopic repair of inguinal hernia

ACTIVE COMPARATOR
Procedure: Laparoscopic repair of inguinal hernia

Open repair of inguinal hernia

ACTIVE COMPARATOR
Procedure: Open repair of inguinal hernia

Interventions

Laparoscopic repair of inguinal hernia

Laparoscopic repair of inguinal hernia

Repair of inguinal hernia by open technique-mesh hernioplasty -

Open repair of inguinal hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patient \> 18 years of age
  • Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.

You may not qualify if:

  • Emergency procedures .
  • ASA score \> 2.
  • Irreducible inguinoscrotal hernia .
  • Local or systemic infection .
  • Other abdominal hernias being operated at the same time or planned operated during Follow up.
  • Previous surgery which has impaired the sensation in the groin area .
  • BMI \> 40 kg/m2.
  • Known disease which Impairs central or peripheral nerve function .
  • Concurrent malignant Disease .
  • Chronic pain which requires daily medication . • Mental disorder which requires daily medication .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Bhandarkar DS, Shankar M, Udwadia TE. Laparoscopic surgery for inguinal hernia: Current status and controversies. J Minim Access Surg. 2006 Sep;2(3):178-86. doi: 10.4103/0972-9941.27735.

    PMID: 21187993BACKGROUND
  • Aguirre DA, Casola G, Sirlin C. Abdominal wall hernias: MDCT findings. AJR Am J Roentgenol. 2004 Sep;183(3):681-90. doi: 10.2214/ajr.183.3.1830681. No abstract available.

    PMID: 15333356BACKGROUND
  • McCormack K, Wake B, Perez J, Fraser C, Cook J, McIntosh E, Vale L, Grant A. Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. Health Technol Assess. 2005 Apr;9(14):1-203, iii-iv. doi: 10.3310/hta9140.

    PMID: 15842951BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Abdul-aziz M Abdul-aziz

CONTACT

Alaa A Redwan, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at General, Oncology, Laparoscopic Surgery Department , Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 23, 2024

Study Start

June 10, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

July 23, 2024

Record last verified: 2024-06

Locations