NCT02314091

Brief Summary

Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 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

Study Start

First participant enrolled

January 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

December 8, 2014

Last Update Submit

December 9, 2014

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • recurrence

    3 years

Study Arms (2)

Onlay

EXPERIMENTAL

Onlay mesh repair group

Procedure: onlay mesh hernioplasty

sublay

EXPERIMENTAL

Sublay mesh repair group

Procedure: onlay mesh hernioplasty

Interventions

onlay mesh hernioplastyPROCEDURE
Onlaysublay

Eligibility Criteria

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

You may qualify if:

  • Incisional hernia
  • Acceptance of the trial

You may not qualify if:

  • BMI\>40
  • ASA score of 4
  • Severe pulmonary or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic 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
M.D.

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2014

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

TU(1)