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

• ClinicalTrials.gov Identifier: NCT02121743
• Recruitment Status: Active, not recruiting
• First Posted: April 23, 2014
• Last Update Posted: March 13, 2023
• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborator: LifeCell
• Information provided by (Responsible Party): Centre Hospitalier Universitaire, Amiens

Tracking Information

• First Submitted Date: April 22, 2014
• First Posted Date: April 23, 2014
• Last Update Posted Date: March 13, 2023
• Actual Study Start Date: April 14, 2014
• Actual Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2014)

rate of parastomal hernia [ Time Frame: postoperative month 6 ]

the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 22, 2014)

• evaluation of the pain [ Time Frame: 2 years after the surgery ]
  The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery
• the postoperative morbidity [ Time Frame: postoperative month 1 ]
  the postoperative morbidity will be assessed with the Dindo Clavien classification
• the parastomal hernia rate [ Time Frame: postoperative year 1 ]
  The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
• the quality of life [ Time Frame: 2 years after the surgery ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Parastomal Hernia
• Terminal Colostomy

Intervention

• Device: strattice
  use of a strattice
• Procedure: No strattice
  no use of a strattice

Study Arms

• Experimental: Strattice
  a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception
  Intervention: Device: strattice
• Placebo Comparator: No strattice
  the colostomy is not reinforced with a mesh
  Intervention: Procedure: No strattice

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 9, 2023): 80
• Original Estimated Enrollment (submitted: April 22, 2014): 108
• Estimated Study Completion Date: December 1, 2023
• Actual Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02121743
• Other Study ID Numbers: PI2014_843_0001; 2013-A01461-44 ( Other Identifier: ID-RCB )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Hospitalier Universitaire, Amiens
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire, Amiens
• Original Study Sponsor: Same as current
• Collaborators: LifeCell

Investigators

• Principal Investigator: jean marc regimbeau, MD, PhD; CHU Amiens

• PRS Account: Centre Hospitalier Universitaire, Amiens
• Verification Date: March 2023