NCT01578538

Brief Summary

Repairing of emergency (strangulated) abdominal wall hernias with mesh may cause infective complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 17, 2012

Status Verified

April 1, 2012

Enrollment Period

2.3 years

First QC Date

April 13, 2012

Last Update Submit

April 16, 2012

Conditions

Hernia

Keywords

hernia, abdominal, strangulation, emergency, wall

Outcome Measures

Primary Outcomes (1)

  • wound infection

    surgical wound infection is the primary outcome measure of this trial

    six months

Study Arms (2)

mesh used repair

ACTIVE COMPARATOR

mesh used hernia repair will be perform

Procedure: inguinal hernia repair

nonmesh

ACTIVE COMPARATOR

nonmesh hernia repair techniques will be used

Procedure: inguinal hernia repair

Interventions

inguinal hernia repairPROCEDURE

strangulated hernias will be repaired surgically

mesh used repairnonmesh

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 16 years old,
  • Strangulated abdominal wall hernia
  • No any contrindications to operation

You may not qualify if:

  • Younger than 16 years old,
  • Non-strangulated abdominal wall hernis
  • Any causes of contrindications to operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Marmara, 34543, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HerniaEmergencies

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

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
prof. dr.

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 17, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2016

Last Updated

April 17, 2012

Record last verified: 2012-04

Locations

TU(1)