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

This study has been completed.
Sponsor:
Information provided by:
Hungarian Surgical Society
ClinicalTrials.gov Identifier:
NCT01018524
First received: October 13, 2009
Last updated: March 7, 2010
Last verified: March 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • chronic pain after hernia surgery [ Time Frame: more one year ] [ Designated as safety issue: No ]
  • complications after hernia surgery [ Time Frame: 0-5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: October 13, 2009
Last Updated: March 7, 2010
Health Authority: Hungary: Institutional Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 17, 2014