Laparoscopic Versus Open Incisional Hernia Repair

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

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-05-31

Study Completion Date

2011-07-31

Brief Summary

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Primary closure of incisional hernia without the use of a mesh shows recurrence rates of up to 54%. If a mesh is used, the defect can be closed tension-free. Using this method, recurrence rates have been reduced to 8-21%. Laparoscopic correction of incisional hernia is a relatively new technique in which the mesh is positioned intraperitoneally. Research has shown that this procedure is technical feasible and may have benefits for the patients.

The ongoing debate about the merits of endoscopic versus open incisional hernia repair prompts the need for a level 1 randomized controlled trial.

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Detailed Description

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Conditions

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Postoperative Pain Complications Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open

open incisional hernia repair

Group Type ACTIVE_COMPARATOR

incisional hernia repair

Intervention Type PROCEDURE

Tension-free open or laparoscopic incisional hernia repair

laparoscopic

laparoscopic incisional hernia repair

Group Type ACTIVE_COMPARATOR

incisional hernia repair

Intervention Type PROCEDURE

Tension-free open or laparoscopic incisional hernia repair

Interventions

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incisional hernia repair

Tension-free open or laparoscopic incisional hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* hernia diameter between 3 and 15 cm
* location at the ventral abdominal wall at least 5cm from costae and inguinal area
* indication for elective repair
* age of 18 years or older
* written informed consent.

Exclusion Criteria

* contraindication for pneumoperitoneum
* an absolute contraindication for general anesthesia
* history of open abdomen treatment
* patients participating in other trials

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No