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Incisional Hernia Repair Long-term Outcomes

NCT04192838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2020-02-05

No results posted yet for this study

Summary

Long-term extension of a previous trial comparing outcomes after open (OVHR) or laparoscopic incisional ventral hernia repair (LVHR), assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up.

Conditions

  • Incisional Hernia

Interventions

PROCEDURE

Laparoscopic incisional ventral hernia repair

Laparoscopic repair of incisional ventral hernias (5-15 cm) with adouble-layer polypropylene- expanded polytetrafluoroethylene (ePTFE) mesh.

PROCEDURE

Open incisional ventral hernia repair

Standard polypropylene mesh was positioned as an inlay, or as an onlay over the external oblique fascia (i.e., subcutaneously), as preferred by the operating team. The mesh was fixed with absorbable stitches. Drains were usually placed.

Sponsors & Collaborators

  • Salvador Peiro

    lead OTHER

Principal Investigators

  • Francisco Asencio-Arana, MD, PhD · Arnau de Vilanova University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-24
Primary Completion
2019-12-24
Completion
2020-01-31

Countries

  • Spain

Study Locations

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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 NCT04192838 on ClinicalTrials.gov