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Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection

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ClinicalTrials.gov Identifier: NCT03520465
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

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.

Condition or disease Intervention/treatment Phase
Eventration Device: DynaMesh®-CICAT longitudinal measure 10x35 cm Not Applicable

Detailed Description:

Randomized prospective experimental study, in which we evaluate patients with CRC who underwent elective intervention for supra-infraumbilical midline laparotomy in order to:

Main objective:

- 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.

Secondary objectives:

  • To compare the appearance of complications in the control group and in the experimental group.
  • Compare costs derived from short and long-term mesh placement in both groups.

We consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind, for the patient and the radiologist who analyses the results of the imaging tests.
Primary Purpose: Prevention
Official Title: Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
Actual Study Start Date : June 27, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supraaponeurotic mesh

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
No Intervention: Monofilament
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®.



Primary Outcome Measures :
  1. Eventration rate [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Complications rate [ Time Frame: 1 year ]
    To compare the appearance of complications in the control group and in the experimental group.

  2. Short and long term derived costs [ Time Frame: 1 year ]
    To compare the costs derived from short and long-term mesh placement in both groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520465


Contacts
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Contact: Laura Segura 0034961246711 investigacion_clinica@iislafe.es

Locations
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Spain
Hospital Universitario y Politécnico La Fe Recruiting
Valencia, Spain
Contact: Laura Segura         
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Matteo Frasson Instituto de Investigación Sanitaria La Fe

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT03520465     History of Changes
Other Study ID Numbers: PEACE
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Gastroschisis
Hernia, Umbilical
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral