NCT04192838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2003

Completed
16.8 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

16.8 years

First QC Date

December 6, 2019

Last Update Submit

February 3, 2020

Conditions

Incisional Hernia

Keywords

Incisional herniaLaparoscopic surgeryRecurrenceHealth Related Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence

    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.

    10-15 years

Secondary Outcomes (3)

  • Surgical repair of recurrent incisional hernia

    10-15 years

  • Mesh related complications

    10-15 years

  • Health Related Quality of Life: EuraHS-QoL questionnaire

    10-15 years

Other Outcomes (1)

  • Rate of deaths

    10-15 years

Study Arms (2)

LVHR

EXPERIMENTAL

Laparoscopic incisional ventral hernia repair

Procedure: Laparoscopic incisional ventral hernia repair

OVHR

ACTIVE COMPARATOR

Open incisional ventral hernia repair

Procedure: Open incisional ventral hernia repair

Interventions

Laparoscopic incisional ventral hernia repairPROCEDURE

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

LVHR
Open incisional ventral hernia repairPROCEDURE

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.

OVHR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Francesc de Borja Hospital

Gandia, Valencia, 46702, Spain

Location

Lluis Alcanyis Hospital

Xàtiva, Valencia, 46800, Spain

Location

Arnau de Vilanova Hospital

Valencia, Spain

Location

Related Publications (2)

  • 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.

    PMID: 19116750BACKGROUND

  • 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.

    PMID: 34018042DERIVED

MeSH Terms

Conditions

Incisional HerniaRecurrence

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesDisease Attributes

Study Officials

  • Francisco Asencio-Arana, MD, PhD

    Arnau de Vilanova University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Health Services Department

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 10, 2019

Study Start

February 24, 2003

Primary Completion

December 24, 2019

Study Completion

January 31, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)