Repair of Inguinal Hernia

NCT ID: NCT06514859

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic repair of inguinal hernia

Group Type ACTIVE_COMPARATOR

Laparoscopic repair of inguinal hernia

Intervention Type PROCEDURE

Laparoscopic repair of inguinal hernia

Open repair of inguinal hernia

Group Type ACTIVE_COMPARATOR

Open repair of inguinal hernia

Intervention Type PROCEDURE

Repair of inguinal hernia by open technique-mesh hernioplasty -

Interventions

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Laparoscopic repair of inguinal hernia

Laparoscopic repair of inguinal hernia

Intervention Type PROCEDURE

Open repair of inguinal hernia

Repair of inguinal hernia by open technique-mesh hernioplasty -

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Male patient \> 18 years of age

• Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.

Exclusion Criteria

* 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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Abdelaziz Mohamed Abdelaziz

Resident at General, Oncology, Laparoscopic Surgery Department , Faculty of Medicine, Sohag University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdul-aziz M Abdul-aziz

Role: CONTACT

01026055970

Alaa A Redwan, Prof

Role: CONTACT

01001988455

Facility Contacts

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Magdy M Amin

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 21187993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15333356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15842951 (View on PubMed)

Other Identifiers

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Soh-Med-24-06-07MS

Identifier Type: -

Identifier Source: org_study_id

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