AzTrials
AzTrials

Ventral HerniaNCT01788826

Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

A study testing Prophylactic mesh and No prophylactic mesh closure in people with Ventral Hernia, run by Henares University Hospital at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The incidence of ventral hernias has remained inappropriately high. Any innovation in order to reduce this incidence would be simply cost-effective. Although there is still some concern about the use of mesh in clean-contaminated or contaminated surgery, based in our experimental studies, we plan to use a mesh in the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventral Hernia
What is being tested?
Prophylactic mesh and No prophylactic mesh closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteSpain
Study dates
Jun 2009to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • More than 18 years old.
  • Patients operated with elective or emergency midline laparotomy with the diagnosis of colorectal cancer.
  • Written informed consent or oral consent with the present of two witnesses who do not participate as investigators in the trial

Who cannot join

  • Dissemination of oncologic disease: all stage IV tumors with estimated survival less than 3 months.
  • Simultaneous participation in another trial with interference of intervention and outcome.
  • Withdrawn or missing written consent.
  • Mental condition rendering the subject incapable of understanding the nature, scope and consequences of the trial.
  • Previous ventral hernia

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Henares University Hospital

    Coslada, Madrid, 28522

Other trials in Spain

About this study

Official title: Randomized Clinical Trial to Evaluate the Use of a Prophylactic Polypropylene Mesh To Reduce the Incidence of Ventral Hernias in Colorectal Surgery

The incidence of ventral hernias has remained inappropriately high. Any innovation in order to reduce this incidence would be simply cost-effective. Although there is still some concern about the use of mesh in clean-contaminated or contaminated surgery, based in our experimental studies, we plan to use a mesh in the primary closure of abdominal incision to prevent incisional hernias.

The investigators propose a clinical trial to assess a model to prevent the incisional hernia after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide polypropylene mesh is fixed covering the midline closure; in the control group a conventional closure with a running suture of long-term absorbable material with a suture/wound length ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of 25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error. The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability during surgery.

The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24 months and abdominal CT controls at 6,12, and 24 months. The study will be statistically evaluated with SPSS 18.0.

Conditions
Ventral Hernia
Being tested
Prophylactic mesh, No prophylactic mesh closure
Keywords
Ventral hernia, surgical meshes, polypropylenes
Medical subject headings
Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prophylactic meshProcedure or surgery

    Closure of midline laparotomy using a prophylactic mesh. The midline is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1. Then, a prefascial large-pore low-weight 5 cm wide polypropylene mesh (Optilene Mesh Elastic, B.Braun) is fixed covering the midline closure. The mesh is fixed in the prefascial plane with absorbable monofilament interrupted sutures, USP 2/0.

  • No prophylactic mesh closureProcedure or surgery

    Closure of midline laparotomy without mesh. The laparotomy is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1.

Study groups in NCT01788826
Study groupRoleWhat they receive
Prophylactic MeshExperimentalUse of a prefascial polypropylene mesh when closing midline laparotomy
Receives: Procedure: Prophylactic mesh
No prophylactic mesh closureExperimentalIn this arm the laparotomy of the patients are closed with a running absorbable suture without a mesh
Receives: Procedure: No prophylactic mesh closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the incidence of ventral hernia between the 2 groups

    Compare the incidence of ventral hernias at the end of the second year follow-up in patients operated for laparotomy using two different methods of abdominal wall closure: one with mesh reinforcement and another one with no mesh reinforcement

    Measured: 24 months

Secondary outcomes (4)

  1. Incidence of superficial surgical site infection

    Compare the incidence of superficial surgical site infection between the 2 groups

    Measured: 30 days

  2. Incidence of deep surgical site infection

    Compare the incidence of deep surgical site infection between the 2 groups

    Measured: 30 days

  3. Seroma

    Incidence of postoperative seroma

    Measured: 30 days

  4. Postoperative complications

    Register of postoperative complications, including pulmonary, fistula and postoperative ileum

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2013 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2011
  4. Study completionSep 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788826
Sponsor's protocol ID
HH01
Status last verified
Feb 2013
First submitted
7 Feb 2013
Last updated
11 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Strzelczyk JM, Szymanski D, Nowicki ME, Wilczynski W, Gaszynski T, Czupryniak L. Randomized clinical trial of postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006 Nov;93(11):1347-50. doi: 10.1002/bjs.5512.

    PubMed 17006977

  • Stringer RA, Salameh JR. Mesh herniorrhaphy during elective colorectal surgery. Hernia. 2005 Mar;9(1):26-8. doi: 10.1007/s10029-004-0274-x. Epub 2004 Sep 10.

    PubMed 15365881

  • Gutierrez de la Pena C, Medina Achirica C, Dominguez-Adame E, Medina Diez J. Primary closure of laparotomies with high risk of incisional hernia using prosthetic material: analysis of usefulness. Hernia. 2003 Sep;7(3):134-6. doi: 10.1007/s10029-003-0124-2. Epub 2003 Apr 3.

    PubMed 12687426

  • O'Hare JL, Ward J, Earnshaw JJ. Late results of mesh wound closure after elective open aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2007 Apr;33(4):412-3. doi: 10.1016/j.ejvs.2006.11.015. Epub 2006 Dec 11.

    PubMed 17164090

  • Bellon JM, Lopez-Hervas P, Rodriguez M, Garcia-Honduvilla N, Pascual G, Bujan J. Midline abdominal wall closure: a new prophylactic mesh concept. J Am Coll Surg. 2006 Oct;203(4):490-7. doi: 10.1016/j.jamcollsurg.2006.06.023. Epub 2006 Aug 23.

    PubMed 17000392

  • Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.

    PubMed 23143146

  • Diaz-Godoy A, Garcia-Urena MA, Lopez-Monclus J, Vega Ruiz V, Melero Montes D, Erquinigo Agurto N. Searching for the best polypropylene mesh to be used in bowel contamination. Hernia. 2011 Apr;15(2):173-9. doi: 10.1007/s10029-010-0762-0. Epub 2010 Dec 9.

    PubMed 21152940

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic mesh and No prophylactic mesh closure in people with Ventral Hernia, run by Henares University Hospital at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the incidence of ventral hernia between the 2 groups (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01788826, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in