Open Mesh Versus Suture Repair in Treatment of Abdominal Wall Hernias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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To determine difference of operation time, applied materials of hernia operations; clinical complications, postoperative pain, hernia recurrence, recovery and normal activity time after surgery.

Conditions

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Abdominal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No