NCT03105895

Brief Summary

It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

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

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

April 4, 2017

Last Update Submit

April 8, 2017

Conditions

Incisional Hernia

Keywords

Incisional herniaMesh preventionMesh augmentation

Outcome Measures

Primary Outcomes (1)

  • Incisional Hernia

    Development of an incisional hernia diagnosed clinically or radiologically

    24 months

Secondary Outcomes (12)

  • Surgical site infection

    30 days

  • Surgical site seroma

    30 days

  • Surgical site hematoma

    30 days

  • Mesh exposition

    30 days

  • Evisceration

    30 days

  • +7 more secondary outcomes

Interventions

Mesh groupPROCEDURE

An onlay PDVF mesh will be placed as abdominal wall reinforcement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing midline laparotomy

You may qualify if:

  • \> 60 years
  • BMI \> 30
  • Chronic bronquitis
  • Smoking
  • Neoplasia
  • Renal failure
  • Liver failure
  • Immnusupression
  • Urgent operation

You may not qualify if:

  • Previous supraumbilical midline laparotomy
  • Previous incisional hernia
  • Emergency surgery
  • Life expectancy of less than 12 months
  • Patient´s rejection to participate
  • Unable to understand and participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Puerto Real University Hospital

Puerto Real, Cádiz, Spain

Location

Sureste Hospital

Arganda, Madrid, Spain

Location

San Agustín University Hospital

Avilés, Principality of Asturias, Spain

Location

University Central Hospital of Asturias

Oviedo, Principality of Asturias, Spain

Location

Nuestra Señora del Prado University Hospital

Talavera de la Reina, Toledo, Spain

Location

Puerta de Hierro University Hospital

Madrid, Spain

Location

Related Publications (1)

  • Rodicio Miravalles JL, Mendez CSM, Lopez-Monclus J, Moreno Gijon M, Lopez Quindos P, Amoza Pais S, Lopez Lopez A, Garcia Bear I, Menendez de Llano Ortega R, Diez Perez de Las Vacas MI, Garcia-Urena MA. Short-term outcomes of a multicentre prospective study using a "visible" polyvinylidene fluoride onlay mesh for the prevention of midline incisional hernia. Langenbecks Arch Surg. 2024 Apr 23;409(1):136. doi: 10.1007/s00423-024-03307-x.

    PMID: 38652308DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2020

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

This is study to watch the behavior of an onlay mesh for incisional hernia prevention after laparotomy

Locations

ES(6)