Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias (HSS-AHS)

March 7, 2010 updated by: Hungarian Surgical Society

Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)

The purpose of this study is to:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Pecs, Hungary, 7624
        • Dept. of Surgery Univ. of Pecs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: small hernias - suture repair
Procedure: abdominal wall reconstruction
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
ACTIVE_COMPARATOR: small hernias - mesh repair
Procedure: abdominal wall reconstruction
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
ACTIVE_COMPARATOR: large hernias - sublay mesh
Procedure: abdominal wall reconstruction
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate
ACTIVE_COMPARATOR: large hernias - onlay mesh
Procedure: abdominal wall reconstruction
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrence rate after hernia surgery
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
chronic pain after hernia surgery
Time Frame: more one year
more one year
complications after hernia surgery
Time Frame: 0-5 years
0-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hungarian Surgical Society

Investigators

  • Principal Investigator: György Wéber, Prof. Dr., Hungarian Surgical Society
  • Study Director: József Baracs, Dr., Hungarian Surgical Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (ESTIMATE)

November 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 7, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSS-AHS 02-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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