Incisional Hernia Repair Long-term Outcomes

Not Applicable

Completed

• Conditions: Incisional Hernia
• Interventions: Procedure: Laparoscopic incisional ventral hernia repair; Procedure: Open incisional ventral hernia repair

• Registration Number: NCT04192838
• Lead Sponsor: Salvador Peiro

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2003-02-24
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Primary Completion: 2019-12-24
• Study Completion: 2020-01-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LVHR	Laparoscopic incisional ventral hernia repair	Laparoscopic incisional ventral hernia repair
OVHR	Open incisional ventral hernia repair	Open incisional ventral hernia repair

Primary Outcome Measures

Name	Time	Method
Hernia recurrence	10-15 years	Rate of participants with hernia recurrence assessed by: 1) clinical evaluation during the first year of follow-up, taking advantage of the original RTC data, available for all patients in the study; 2) clinical evaluation, accompanied when necessary by an abdominal CT scan, carried out between 2017 and 2019 for living patients who accepted participation in the extension study; 3) review of the EMR, including available abdominal CT scans close to patients' death, for patients deceased prior to the clinical evaluation of the extension study.

Secondary Outcome Measures

Name	Time	Method
Surgical repair of recurrent incisional hernia	10-15 years	Rate of participants with a hernia reoperation assessed by: 1) clinical evaluation during the first year of follow-up, taking advantage of the original RTC data, available for all patients in the study; 2) clinical evaluation carried out between 2017 and 2019 for living patients who accepted participation in the extension study; 3) review of the EMR for patients deceased prior to the clinical evaluation of the extension study.
Mesh related complications	10-15 years	Rate of participants with a reoperation for intestinal obstruction, or mesh extrusion, or intestinal fistulas, or adhesion syndrome treated conservatively. Only for intraperitoneal mesh
Health Related Quality of Life: EuraHS-QoL questionnaire	10-15 years	The EuraHS-QoL questionnaire was used for assessing HRQoL in living no reoperated patients who accepted participation in the clinical evaluation of the extension study. The EuraHS-QoL scale is a hernia specific HRQoL self-administered questionnaire with 9 items that can be scored by the patient in an 11-point scale (from 0 to 10). The total score ranges from 0-90, with the lower scores being the most favourable outcome.

Trial Locations

Locations (3)

Francesc de Borja Hospital; 🇪🇸 Gandia, Valencia, Spain

Lluis Alcanyis Hospital; 🇪🇸 Xàtiva, Valencia, Spain

Arnau de Vilanova Hospital; 🇪🇸 Valencia, Spain