Clinical trial NCT01018524: Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias
Official title: Results of Open Mesh Versus Suture Repair in Treatment of Abdominal Wall (Multicentric, Prospective, Randomised, Internet-based, Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Hernia
Keywords: position of the mesh
recurrence rate
surgical procedure
long time outcome
Lead sponsor: Hungarian Surgical Society
Sponsor class: NETWORK
First posted: 2009-11-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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 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.

Primary outcomes:
measure: recurrence rate after hernia surgery
timeFrame: 5 years
Secondary outcomes:
measure: chronic pain after hernia surgery
timeFrame: more one year
measure: complications after hernia surgery
timeFrame: 0-5 years
Other outcomes:
Locations:
city: Pecs
country: Hungary
facility: Dept. of Surgery Univ. of Pecs
Study officials:
affiliation: Hungarian Surgical Society
name: György Wéber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hungarian Surgical Society
name: József Baracs, Dr.
role: STUDY_DIRECTOR
References:
citation: Weber G, Horvath 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.
citation: Weber G, Baracs J, Horvath OP. ["Onlay" mesh provides significantly better results than "sublay" reconstruction. Prospective randomized multicenter study of abdominal wall reconstruction with sutures only, or with surgical mesh--results of a five-years follow-up]. Magy Seb. 2010 Oct;63(5):302-11. doi: 10.1556/MaSeb.63.2010.5.3. Hungarian.