NCT01018524

Brief Summary

The purpose of this study is to:

  1. 1.compare the long term results of mesh versus suture repair in treatment of abdominal wall defects;
  2. 2.find the optimal location of implanted prosthesis, comparing the two most useful position of mesh in abdominal wall hernia surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_4

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

March 1, 2002

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2010

Enrollment Period

7 years

First QC Date

October 13, 2009

Last Update Submit

March 7, 2010

Conditions

Abdominal Hernia

Keywords

position of the meshrecurrence ratesurgical procedurelong time outcome

Outcome Measures

Primary Outcomes (1)

  • recurrence rate after hernia surgery

    5 years

Secondary Outcomes (2)

  • chronic pain after hernia surgery

    more one year

  • complications after hernia surgery

    0-5 years

Study Arms (4)

small hernias - suture repair

ACTIVE COMPARATOR
Procedure: abdominal wall reconstruction

small hernias - mesh repair

ACTIVE COMPARATOR
Procedure: abdominal wall reconstruction

large hernias - sublay mesh

ACTIVE COMPARATOR
Procedure: abdominal wall reconstruction

large hernias - onlay mesh

ACTIVE COMPARATOR
Procedure: abdominal wall reconstruction

Interventions

abdominal wall reconstructionPROCEDURE

suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate

large hernias - onlay meshlarge hernias - sublay meshsmall hernias - mesh repairsmall hernias - suture repair

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • During the two-year randomization period at the joined centres all patients were included who were admitted with abdominal wall or umbilical hernia and who suited the requirements.
  • All the patients with primer or first recurrence of postoperative abdominal or primer or first recurrence of umbilical hernia were randomized into this study.
  • For involvement into the study good patient compliance, signed consent form, normal local circumstances were needed.

You may not qualify if:

  • Ages fewer than 18 or above 70 years
  • Hernia orifice under 5 cm2.
  • Planned or accidental intraoperative opening of any bowel.
  • Unstable parameters of circulation, uncontrollable diabetic or autoimmune disease.
  • Severe renal or hepatic failure
  • Advanced stage of tumours or currently treated malignancies.
  • Inflamed or muddy content of hernia sac.
  • If the patient did not signed the consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery Univ. of Pecs

Pécs, 7624, Hungary

Location

Related Publications (2)

  • Weber G, Horvath OP. [Results of ventral hernia repair: comparison of suture repair with mesh implantation (onlay vs sublay) using open and laparoscopic approach--prospective, randomized, multicenter study]. Magy Seb. 2002 Oct;55(5):285-9. Hungarian.

    PMID: 12474512BACKGROUND

  • Weber G, Baracs J, Horvath OP. ["Onlay" mesh provides significantly better results than "sublay" reconstruction. Prospective randomized multicenter study of abdominal wall reconstruction with sutures only, or with surgical mesh--results of a five-years follow-up]. Magy Seb. 2010 Oct;63(5):302-11. doi: 10.1556/MaSeb.63.2010.5.3. Hungarian.

    PMID: 20965863DERIVED

MeSH Terms

Conditions

Hernia, Abdominal

Interventions

Abdominoplasty

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • György Wéber, Prof. Dr.

    Hungarian Surgical Society

    PRINCIPAL INVESTIGATOR

  • József Baracs, Dr.

    Hungarian Surgical Society

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 13, 2009

First Posted

November 23, 2009

Study Start

March 1, 2002

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 9, 2010

Record last verified: 2010-03

Locations

HU(1)