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

Primary Purpose

Eventration

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DynaMesh®-CICAT longitudinal measure 10x35 cm
Sponsored by
Instituto de Investigacion Sanitaria La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eventration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Universitario y Politécnico La FeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supraaponeurotic mesh

Monofilament

Arm Description

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 Drainage will be preserved for a minimum of 48 hours after surgery, and will be withdrawn when a debit of less than 50 ml is presented in 24 h.

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®.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2018
Last Updated
August 12, 2019
Sponsor
Instituto de Investigacion Sanitaria La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT03520465
Brief Title
Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
Official Title
Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eventration

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind, for the patient and the radiologist who analyses the results of the imaging tests.
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supraaponeurotic mesh
Arm Type
Experimental
Arm Description
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.
Arm Title
Monofilament
Arm Type
No Intervention
Arm Description
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®.
Intervention Type
Device
Intervention Name(s)
DynaMesh®-CICAT longitudinal measure 10x35 cm
Primary Outcome Measure Information:
Title
Eventration rate
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications rate
Description
To compare the appearance of complications in the control group and in the experimental group.
Time Frame
1 year
Title
Short and long term derived costs
Description
To compare the costs derived from short and long-term mesh placement in both groups.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Segura
Phone
0034961246711
Email
investigacion_clinica@iislafe.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matteo Frasson
Organizational Affiliation
Instituto de Investigación Sanitaria La Fe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Segura

12. IPD Sharing Statement

Plan to Share IPD
No

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

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