Clinical trial NCT02121743: Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy
Official title: Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parastomal Hernia
Terminal Colostomy
Keywords: strattice
colostomy
parastomal hernia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: LifeCell
First posted: 2014-04-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.


Eligibility criteria: Inclusion Criteria:

* Patient requiring a colorectal surgery with a terminal colostomy
* Elective or emergency surgery

Exclusion Criteria:

* Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
* Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
* Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs
* Is pregnant, or lactating.
* Allergic to any porcine or collagen products.
* survival \< 6 months

Primary outcomes:
measure: rate of parastomal hernia
timeFrame: postoperative month 6
Secondary outcomes:
measure: evaluation of the pain
timeFrame: 2 years after the surgery
measure: the postoperative morbidity
timeFrame: postoperative month 1
measure: the parastomal hernia rate
timeFrame: postoperative year 1
measure: the quality of life
timeFrame: 2 years after the surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens Universitary Hospital
city: Amiens
country: France
facility: Amiens university hospital
city: Beauvais
country: France
facility: Beauvais hospital
city: Caen
country: France
facility: Caen hospital
city: Lille
country: France
facility: Claude Huriet Hospital
city: Paris
country: France
facility: Lariboisiere Hospital
city: Rouen
country: France
facility: Charles Nicolle Hospital
Study officials:
affiliation: CHU Amiens
name: jean marc regimbeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.
citation: Lee L, Saleem A, Landry T, Latimer E, Chaudhury P, Feldman LS. Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer. J Am Coll Surg. 2014 Jan;218(1):82-91. doi: 10.1016/j.jamcollsurg.2013.09.015. Epub 2013 Sep 29.
citation: Swann JM, Turek FW. Transfer from long to short days reduces the frequency of pulsatile luteinizing hormone release in intact but not in castrated male golden hamsters. Neuroendocrinology. 1988 Apr;47(4):343-9. doi: 10.1159/000124935.