Hernia Prevention in Stomas

Incisional Hernia Clinical Trial

Official title:

Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907842
• Other study ID #: MEC09-2-052
• Secondary ID: NL27625.068.09
• Status: Completed
• Phase: N/A
• First received: May 21, 2009
• Last updated: April 5, 2013
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Academisch Ziekenhuis Maastricht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.

Description:

The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with a life expectancy of at least one year

• Temporary stoma formation

• Signed informed consent

• Elective surgery

• Clean-contaminated abdomen

Exclusion Criteria:

• American Society of Anaesthesiologists (ASA) score IV or above

• Incapacitated adult or no signed informed consent

• Emergency procedure

• Contaminated or infected abdomen

• Residual intraperitoneal mesh

• Already injured part of the abdominal wall where the stoma will be sited

• Contraindication to laparoscopy

• Longterm use of corticosteroids and other immunosuppressive agents

• Current antibiotic therapy

• One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Parastomal Hernia

Intervention

Device:
• Parietex Parastomal Mesh
mesh placed intraperitoneally around the stoma

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Marc Schreinemacher

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. — View Citation

Jänes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)		one year after placement	Yes
Primary	incisional herniation at the old stoma wound		two years	No
Secondary	stoma complications (stenosis, bulging, prolapse, retraction, skin problems)		two years after placement	Yes