Laparoscopic Versus Open Incisional Hernia Repair

NCT01420757 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2011-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Pain
  • Complications
  • Recurrence

Interventions

PROCEDURE

incisional hernia repair

Tension-free open or laparoscopic incisional hernia repair

Sponsors & Collaborators

Principal Investigators

  • J.F. Lange, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-31
Primary Completion
2006-12-31
Completion
2011-07-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420757 on ClinicalTrials.gov