NCT04269330

Brief Summary

Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

February 3, 2020

Last Update Submit

October 2, 2020

Conditions

General SurgeryInguinal HerniaVentral Hernia

Keywords

mesh sizelichtenstein hernia repairsurgical technique

Outcome Measures

Primary Outcomes (1)

  • The success of treatment.

    The success of normal size mesh with small mesh as a result of hernia treatment

    1 year

Secondary Outcomes (1)

  • patient satisfaction

    1 year

Study Arms (2)

1-Normal size mesh in open inguinal herni

SHAM COMPARATOR

Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

2- small size mesh in open inguinal herni

ACTIVE COMPARATOR

Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

Procedure: Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

Interventions

Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.PROCEDURE

Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.

1-Normal size mesh in open inguinal herni2- small size mesh in open inguinal herni

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages must be upper 18

You may not qualify if:

  • Morbit obesity (BMI\>40)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (3)

  • Kulacoglu H, Celasin H, Oztuna D. Individual mesh size for open anterior inguinal hernia repair: an anthropometric study in Turkish male patients. Hernia. 2019 Dec;23(6):1229-1235. doi: 10.1007/s10029-019-01993-x. Epub 2019 Jun 20.

    PMID: 31222460BACKGROUND

  • Anitha B, Aravindhan K, Sureshkumar S, Ali MS, Vijayakumar C, Palanivel C. The Ideal Size of Mesh for Open Inguinal Hernia Repair: A Morphometric Study in Patients with Inguinal Hernia. Cureus. 2018 May 3;10(5):e2573. doi: 10.7759/cureus.2573.

    PMID: 29974028BACKGROUND

  • Seker D, Oztuna D, Kulacoglu H, Genc Y, Akcil M. Mesh size in Lichtenstein repair: a systematic review and meta-analysis to determine the importance of mesh size. Hernia. 2013 Apr;17(2):167-75. doi: 10.1007/s10029-012-1018-y. Epub 2012 Nov 11.

    PMID: 23142904BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalHernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alpaslan Şahin, MD

    Konya Training and Research Hospital, Department of General Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, principal investigator, General Surgery Department

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 13, 2020

Study Start

February 20, 2020

Primary Completion

September 20, 2020

Study Completion

October 2, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

TU(1)