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Trial record 17 of 32 for:    "Gastroschisis"

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 : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE June 27, 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03520465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • Complications rate [ Time Frame: 1 year ]
    To compare the appearance of complications in the control group and in the experimental group.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
Official Title  ICMJE Utility of a Supraaponeurotic Mesh as Prophylaxis of the Midline Eventration After an Oncological Colorrectal Resection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Eventration
Intervention  ICMJE Device: DynaMesh®-CICAT longitudinal measure 10x35 cm
Study Arms  ICMJE
  • 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.

    Intervention: 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®.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2018)
154
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Segura 0034961246711 investigacion_clinica@iislafe.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520465
Other Study ID Numbers  ICMJE PEACE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Instituto de Investigacion Sanitaria La Fe
Study Sponsor  ICMJE Instituto de Investigacion Sanitaria La Fe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matteo Frasson Instituto de Investigación Sanitaria La Fe
PRS Account Instituto de Investigacion Sanitaria La Fe
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP