Hernia Prevention in Stomas

NCT00907842 | Completed

• 2 other identifiers: MEC09-2-052NL27625.068.09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incisional Hernia; Parastomal Hernia

Keywords

stoma

Outcome Measures

Primary Outcomes (2)

• postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)

  one year after placement

• incisional herniation at the old stoma wound

  two years

Secondary Outcomes (1)

• stoma complications (stenosis, bulging, prolapse, retraction, skin problems)

  two years after placement

Study Arms (1)

mesh placement

EXPERIMENTAL

Device: Parietex Parastomal Mesh

Interventions

Parietex Parastomal Mesh DEVICE

mesh placed intraperitoneally around the stoma

mesh placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with a life expectancy of at least one year
• Temporary stoma formation
• Signed informed consent
• Elective surgery
• Clean-contaminated abdomen

You may not qualify if:

• 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

Sponsors & Collaborators

• Marc Schreinemacher: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6200 AZ, Netherlands

Location

Related Publications (2)

• Janes 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.

  PMID: 19011935 BACKGROUND

• 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. doi: 10.1007/s10350-006-0681-4.

  PMID: 17120189 BACKGROUND

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Nicole Bouvy, MD, PhD

  Maastricht University Medical Centre

  STUDY DIRECTOR

• Marc Schreinemacher, MD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: April 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

NL (1)