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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018524
First Posted: November 23, 2009
Last Update Posted: March 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hungarian Surgical Society
  Purpose

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.

Condition Intervention Phase
Abdominal Hernia Procedure: abdominal wall reconstruction Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)

Resource links provided by NLM:


Further study details as provided by Hungarian Surgical Society:

Primary Outcome Measures:
  • recurrence rate after hernia surgery [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • chronic pain after hernia surgery [ Time Frame: more one year ]
  • complications after hernia surgery [ Time Frame: 0-5 years ]

Enrollment: 2
Study Start Date: March 2002
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018524


Locations
Hungary
Dept. of Surgery Univ. of Pecs
Pecs, Hungary, 7624
Sponsors and Collaborators
Hungarian Surgical Society
Investigators
Principal Investigator: György Wéber, Prof. Dr. Hungarian Surgical Society
Study Director: József Baracs, Dr. Hungarian Surgical Society
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. O.P. Horvath, Hungarian Surgical Society
ClinicalTrials.gov Identifier: NCT01018524     History of Changes
Other Study ID Numbers: HSS-AHS 02-09
First Submitted: October 13, 2009
First Posted: November 23, 2009
Last Update Posted: March 9, 2010
Last Verified: March 2010

Keywords provided by Hungarian Surgical Society:
position of the mesh
recurrence rate
surgical procedure
long time outcome

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical