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Prophylaxis of Ileostomy Closure Site Hernia by Placing Mesh (ILEOCLOSE)

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ClinicalTrials.gov Identifier: NCT02226887
Recruitment Status : Unknown
Verified April 2017 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : August 27, 2014
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

Design Prospective , randomized, parallel phase IV.

Objectives Main objective

  • Evaluate the effectiveness of the placement of a resorbable mesh in the prevention of incisional hernia of the abdominal wall at the site of a loop ileostomy when it is "closed " to rebuild the intestinal transit. The effectiveness evaluation is done by tracking with scheduled patient visits for 12 months, assessing the physical examination the presence or absence of an incisional hernia and an abdominal tomography at the end of the 12 months .

Secondary objectives Comparison of complications(morbidity and mortality) to assess safety and tolerability of the placement of the mesh described .


Condition or disease Intervention/treatment Phase
Loop Ileostomy Closure Procedure: MESH Procedure: NO MESH Radiation: Post-operative Imaging Radiation: Pre-operative Imaging Other: Blood Test and C-reactive protein at 4th day Phase 4

Detailed Description:
Experimental: Reinforcement with Absorbable Mesh Closure of the ileostomy closure incision is reinforced with insertion of a rectangular segment (1 cm wide and the length corresponding to the incision) of a prosthetic commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA) mesh. The BIO-A® prosthesis is inserted using a "sandwich" method between the edges of the incision and maintained in situ with a continuous polydioxanone (PDS) suture following a suture length to wound length (SL:WL) ratio of 4:1.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: "Prospective Randomized Clinical Trial of Ileostomy Closure Site Hernia and it´s Prophylaxis by Placing an Absorbable Mesh "
Actual Study Start Date : April 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: MESH Procedure: MESH
  1. Pre-operative :

    It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .

  2. Surgical technique:

    • Peristomal incision with electrocautery
    • Release the handle of ileum
    • Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
    • Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
    • We add the mesh between the edges of the defect during fascia closure.
    • The skin is sutured "purse string" style.
  3. Post-Op

    • Hospital discharge after verification of normal digestive transit.
Other Name: Mesh : GORE® BIO-A®

Radiation: Post-operative Imaging
Abdominal Tomography 1 year after ileostomy closure

Radiation: Pre-operative Imaging
Contrast study is used to ensure the integrity of the distal anastomosis

Other: Blood Test and C-reactive protein at 4th day
All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.

Active Comparator: NO MESH Procedure: NO MESH
  1. Pre-operative :

    It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .

  2. Surgical technique:

    • Peristomal incision with electrocautery
    • Release the handle of ileum
    • Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
    • Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
    • The skin is sutured "purse string" style.

Post-Op

- Hospital discharge after verification of normal digestive transit

Other Name: Protocol Ileostomy closure

Radiation: Post-operative Imaging
Abdominal Tomography 1 year after ileostomy closure

Radiation: Pre-operative Imaging
Contrast study is used to ensure the integrity of the distal anastomosis

Other: Blood Test and C-reactive protein at 4th day
All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.




Primary Outcome Measures :
  1. Eventration [ Time Frame: 1 year ]
    Measured by clinical checks at 1 - 6 - 12 months and Abdominal tomography 1 year after the surgery.


Secondary Outcome Measures :
  1. Occlusive problems [ Time Frame: 30 days after surgery ]

    Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),....

    • This is a Clinical measure supported by image if necessary
    • All the morbidity problems are reported independently.
    • 1 patient can suffer a prolonged ileus and Anastomotic stenosis and both will be reported.

  2. Iatrogenic problems [ Time Frame: 30 days after surgery ]

    Damage to structures such as ureters, bowel loops artery / iliac vein ....

    • This is a Surgical and Clinical measure supported by image if necessary.
    • All the morbidity problems are reported independently.

  3. Impaired healing [ Time Frame: 30 days after surgery ]

    Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...

    • This is a Clinical measure always supported by image tests.
    • All the morbidity problems are reported independently.

  4. Bleeding problems [ Time Frame: 30 days after surgery ]

    Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....

    • This is a Clinical measure supported by image if necessary.
    • All the morbidity problems are reported independently.
    • The amount of blood loss won't be specified

  5. Cardiac complications [ Time Frame: 30 days after surgery ]

    acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema

    • This is a Clinical measure supported by more specific tests if necessary.
    • All the morbidity problems are reported independently.
    • Cardiologist report will be required for including this items

  6. Nephro-urinary complications [ Time Frame: 30 days after surgery ]

    Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...

    • This is a Clinical measure supported by more specific tests if necessary.
    • All the morbidity problems are reported independently.

  7. Respiratory complications [ Time Frame: 30 days after surgery ]

    Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...

    • This is a Clinical measure always supported by image .
    • All the morbidity problems are reported independently.

  8. Vascular Complications [ Time Frame: 30 days after surgery ]

    Deep venous thrombosis, phlebitis, thrombophlebitis, ...

    • This is a Clinical measure supported by more specific test if necessary .
    • All the morbidity problems are reported independently

  9. Gastrointestinal complications [ Time Frame: 30 days after surgery ]

    Liver failure, gastrointestinal bleeding, severe malnutrition, ...

    • This is a Clinical measure supported by blood test and further test if necessary
    • All the morbidity problems are reported independently.

  10. Neurological complications [ Time Frame: 30 days after surgery ]

    Disorientation, cerebral vascular accident, ...

    • This is a Clinical measure.
    • All the morbidity problems are reported independently.
    • Neurologist report will be required beyond disorientation.

  11. Local infection [ Time Frame: 30 days after surgery ]

    Superficial, deep, body-cavity

    • This is a Clinical measure supported by image if necessary
    • All the morbidity problems are reported independently

  12. Local complications [ Time Frame: 30 days after surgery ]

    Hematoma, seroma, evisceration

    • This is a Clinical measure
    • All the morbidity problems are reported independently

  13. Hospital stay [ Time Frame: Days ]
    Hospital stay since surgery is done



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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:

  • Patients undergoing a loop ileostomy closure

Exclusion Criteria:

  • Patients under 18
  • Pregnancy and Lactation
  • Patients allergic to polyglycolic / trimethylene carbonate
  • Carrier of prosthetic mesh in the ostomy
  • Patients presenting midline hernia.
  • Patients affected by inflammatory bowel disease

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): NCT02226887


Locations
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Spain
Hospital General Universitario Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Contact: Borja Villanueva, MD    +34 629801238    b.villanueva@hotmail.com   
Principal Investigator: Borja Villanueva Figueredo, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Borja Villanueva Figueredo, MD Hospital Universitari Vall d'Hebron Research Institute
Study Director: Francesc Vallribera Valls, MD,PhD Hospital Universitari Vall d'Hebron Research Institute
Study Director: Manuel Lopez-Cano, MD, PhD Hospital Universitari Vall d'Hebron Research Institute

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02226887     History of Changes
Other Study ID Numbers: PR(AG)288/2013
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Loop ileostomy
Eventration
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical