Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias

Abdominal Hernia Clinical Trial

— HSS-AHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018524
• Other study ID #: HSS-AHS 02-09
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: March 7, 2010
• Start date: March 2002
• Est. completion date: March 2009

Study information

• Verified date: March 2010
• Source: Hungarian Surgical Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Abdominal Hernia
• Hernia, Abdominal

Intervention

Procedure:
• abdominal wall reconstruction
suture repair, mesh repair, onlay mesh reconstruction, sublay mesh reconstruction, recurrence rate

Locations

Country	Name	City	State
Hungary	Dept. of Surgery Univ. of Pecs	Pecs

Sponsors (1)

Lead Sponsor	Collaborator
Hungarian Surgical Society

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Wéber G, Horváth 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate after hernia surgery		5 years	Yes
Secondary	chronic pain after hernia surgery		more one year	No
Secondary	complications after hernia surgery		0-5 years	No