Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia

Parastomal Hernia Clinical Trial

Official title:

Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908661
• Other study ID #: PR(AG)116/2006
• Status: Completed
• Phase: N/A
• First received: May 25, 2009
• Last updated: March 23, 2017
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if a mesh is effective in the prevention of a parastomal hernia when a permanent ostomy is performed through a laparoscopic approach.

Description:

Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.

Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with permanent ostomy and 1 years of life expectancy

• Signed informed consent

Exclusion Criteria:

• Allergy to the compounds of the mesh

• Rejection of the patient

• Rejection of the surgeon

• Field of emergency

• Life expectancy < 1 year

• Prior meshes in the surgical site

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia

Intervention

Device:
• Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh

Locations

Country	Name	City	State
Spain	Hospital Universitari Valldhebron Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (2)

López-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58. — View Citation

Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done		24 to 36 months after surgery
Secondary	Measuring the quality of life using the SF-36		Preoperative and at the end of the study