Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

Parastomal Hernia Clinical Trial

— PROBIOCOL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02121743
• Other study ID #: PI2014_843_0001
• Secondary ID: 2013-A01461-44
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2014
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Parastomal Hernia
• Terminal Colostomy

Intervention

Device:
• strattice
use of a strattice

Procedure:
• No strattice
no use of a strattice

Locations

Country	Name	City	State
France	Amiens Universitary Hospital	Amiens
France	Amiens university hospital	Amiens
France	Beauvais hospital	Beauvais
France	Caen hospital	Caen
France	Claude Huriet Hospital	Lille
France	Lariboisiere Hospital	Paris
France	Charles Nicolle Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	LifeCell

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of parastomal hernia	the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan	postoperative month 6
Secondary	evaluation of the pain	The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery	2 years after the surgery
Secondary	the postoperative morbidity	the postoperative morbidity will be assessed with the Dindo Clavien classification	postoperative month 1
Secondary	the parastomal hernia rate	The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination	postoperative year 1
Secondary	the quality of life	The quality of life will be assessed with the STOMA QoL form, the 12-Item Short Form Health Survey (SF12) and the Carolina comfort scale at 1 month, 6 months, 1 year and 2 years after the surgery	2 years after the surgery