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Completed

NCT Number: NCT04192838

Incisional Hernia Repair Long-term Outcomes

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.

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Key information

Conditions

Incisional Hernia Disease Attributes Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francesc de Borja Hospital, Gandia, Valencia, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic incisional ventral hernia repair

Procedure

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

Open incisional ventral hernia repair

Procedure

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.

Primary outcomes

  1. Hernia recurrence

    Time frame: 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 outcomes

  1. Surgical repair of recurrent incisional hernia

    Time frame: 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.

  2. Mesh related complications

    Time frame: 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

  3. Health Related Quality of Life: EuraHS-QoL questionnaire

    Time frame: 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.

Other outcomes

  1. Rate of deaths

    Time frame: 10-15 years

    Death for any cause

Sponsors and collaborators

Lead sponsor

Salvador Peiro

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2019
Study completion
2020
First posted
Dec 10, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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