Incisional Hernia Repair Long-term Outcomes

Incisional Hernia Clinical Trial

Official title: Long-term Outcomes and Quality of Life of Incisional Ventral Hernia Repair by Open or Laparoscopy Surgery: Randomized Clinical Trial Extension

Status Completed

Clinical Trial 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.

Clinical Trial Description

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

Patients will be followed to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index surgery (between 2003 to 2006) until recurrence, death or study completion with a clinical revision (between 2017 to 2019) whichever was first. By intention to treat, incidence rates of recurrence, reintervention and death by 1000 person-year of follow-up will be estimated, and also rates of mesh complications by 1000 person-year for the LVHR group excluding conversions. Quality of life, using the European Hernia Society Quality of Life score (EuraHS-QoL), will be assessed for survivors no reoperated patients ;

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

• NCT number: NCT04192838
• Study type: Interventional
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Status: Completed
• Phase: N/A
• Start date: February 24, 2003
• Completion date: January 31, 2020