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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014