Incisional Hernia Repair Long-term Outcomes

Salvador Peiro

Status: Completed

Conditions: Incisional Hernia

Treatments: Procedure: Laparoscopic incisional ventral hernia repair; Procedure: Open incisional ventral hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT04192838

IH/AV/2017

Details and patient eligibility

About

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.

Full 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

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Incisional hernia between 5 and 15 cm in largest diameter
• No ontraindication for laparoscopic surgery.

Exclusion criteria

• Patients with any type of stoma,
• Non-residente in the Valencia región

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

LVHR

Experimental group

Description:

Laparoscopic incisional ventral hernia repair

Treatment:

Procedure: Laparoscopic incisional ventral hernia repair

OVHR

Active Comparator group

Description:

Open incisional ventral hernia repair

Treatment:

Procedure: Open incisional ventral hernia repair