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

Hungarian Surgical Society

Status and phase: Completed; Phase 4

Conditions: Abdominal Hernia

Treatments: Procedure: abdominal wall reconstruction

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01018524

HSS-AHS 02-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 4 patient groups

small hernias - suture repair

Active Comparator group

Treatment:

Procedure: abdominal wall reconstruction

small hernias - mesh repair

Active Comparator group

Treatment:

Procedure: abdominal wall reconstruction

large hernias - sublay mesh

Active Comparator group

Treatment:

Procedure: abdominal wall reconstruction

large hernias - onlay mesh

Active Comparator group

Treatment:

Procedure: abdominal wall reconstruction