NCT03520465

Brief Summary

Randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.

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
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

3.9 years

First QC Date

April 27, 2018

Last Update Submit

August 12, 2019

Conditions

Eventration

Outcome Measures

Primary Outcomes (1)

  • Eventration rate

    To assess the effect of the prophylactic mesh in the eventration rate diagnosed by CT at one year after surgery in patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy.

    1 year

Secondary Outcomes (2)

  • Complications rate

    1 year

  • Short and long term derived costs

    1 year

Study Arms (2)

Supraaponeurotic mesh

EXPERIMENTAL

Patients with laparotomy closure by conventional approach of aponeurosis (continuous suture with monofilament of slow absorption), and posterior placement of supraaponeurotic mesh of polyvinylidene fluoride (PVDF) medium / low density and wide pore. The mesh has a longitudinal measurement that exceeds about 3 cm the upper and lower ends of the wound and width should not be less than 10 cm, therefore the mesh selected is DynaMesh®-CICAT longitudinal measure 10x35 cm. The mesh is fixed to the aponeurosis with a crown of loose stitches and points to the midline. A prolene 2/0 non-reabsorbable monofilament suture of cylindrical needle is used. A 10 Fr suction drainage is placed in the supraaponeurotic plane, with an exit to the exterior beyond the edges of the prosthesis. Drainage will be preserved for a minimum of 48 hours after surgery, and will be withdrawn when a debit of less than 50 ml is presented in 24 h.

Device: DynaMesh®-CICAT longitudinal measure 10x35 cm

Monofilament

NO INTERVENTION

Patients with conventional closure of the middle laparotomy with approach of aponeurosis in a plane by continuous suture with monofilament of slow absorption. In this study, the suture used in all patients will be poly-4-hydroxybutyrate or Mono-max loop®.

Interventions

DynaMesh®-CICAT longitudinal measure 10x35 cmDEVICE
Supraaponeurotic mesh

Eligibility Criteria

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

You may qualify if:

  • Elective surgery for colorectal cancer.
  • Surgery by middle laparotomy.
  • Informed consent signed by the patient.
  • Age \> 18 years.

You may not qualify if:

  • Midline hernia or eventration.
  • Presence of mesh in the abdominal wall because of a previous surgery.
  • Palliative surgery.
  • Synchronous metastases (Stage IV cancer according to TNM).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Matteo Frasson

    Instituto de Investigación Sanitaria La Fe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Segura

CONTACT

0034961246711investigacion_clinica@iislafe.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blind, for the patient and the radiologist who analyses the results of the imaging tests.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 9, 2018

Study Start

June 27, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)