Clinical trial NCT04192838: Incisional Hernia Repair Long-term Outcomes
Official title: Long-term Outcomes and Quality of Life of Incisional Ventral Hernia Repair by Open or Laparoscopy Surgery: Randomized Clinical Trial Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Keywords: Incisional hernia
Laparoscopic surgery
Recurrence
Health Related Quality of Life
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Hernia recurrence
timeFrame: 10-15 years
Secondary outcomes:
measure: Surgical repair of recurrent incisional hernia
timeFrame: 10-15 years
measure: Mesh related complications
timeFrame: 10-15 years
measure: Health Related Quality of Life: EuraHS-QoL questionnaire
timeFrame: 10-15 years
Other outcomes:
measure: Rate of deaths
timeFrame: 10-15 years
Locations:
city: Gandia
country: Spain
facility: Francesc de Borja Hospital
state: Valencia
city: Xàtiva
country: Spain
facility: Lluis Alcanyis Hospital
state: Valencia
city: Valencia
country: Spain
facility: Arnau de Vilanova Hospital
Study officials:
affiliation: Arnau de Vilanova University Hospital
name: Francisco Asencio-Arana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asencio F, Aguilo J, Peiro S, Carbo J, Ferri R, Caro F, Ahmad M. Open randomized clinical trial of laparoscopic versus open incisional hernia repair. Surg Endosc. 2009 Jul;23(7):1441-8. doi: 10.1007/s00464-008-0230-4. Epub 2008 Dec 31.
citation: Asencio F, Carbo J, Ferri R, Peiro S, Aguilo J, Torrijo I, Barber S, Canovas R, Andreu-Ballester JC. Laparoscopic Versus Open Incisional Hernia Repair: Long-Term Follow-up Results of a Randomized Clinical Trial. World J Surg. 2021 Sep;45(9):2734-2741. doi: 10.1007/s00268-021-06164-7. Epub 2021 May 20.