NCT02121743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

4.6 years

First QC Date

April 22, 2014

Last Update Submit

March 9, 2023

Conditions

Parastomal HerniaTerminal Colostomy

Keywords

stratticecolostomyparastomal hernia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • evaluation of the pain

    2 years after the surgery

  • the postoperative morbidity

    postoperative month 1

  • the parastomal hernia rate

    postoperative year 1

  • the quality of life

    2 years after the surgery

Study Arms (2)

Strattice

EXPERIMENTAL

a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception

Device: strattice

No strattice

PLACEBO COMPARATOR

the colostomy is not reinforced with a mesh

Procedure: No strattice

Interventions

stratticeDEVICE

use of a strattice

Strattice
No stratticePROCEDURE

no use of a strattice

No strattice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Amiens Universitary Hospital

Amiens, France

Location

Amiens university hospital

Amiens, France

Location

Beauvais hospital

Beauvais, France

Location

Caen hospital

Caen, France

Location

Claude Huriet Hospital

Lille, France

Location

Lariboisiere Hospital

Paris, France

Location

Charles Nicolle Hospital

Rouen, France

Location

Related Publications (3)

  • 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.

    PMID: 24238119BACKGROUND

  • 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.

    PMID: 24210147BACKGROUND

  • 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.

    PMID: 3374759BACKGROUND

Study Officials

  • jean marc regimbeau, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 23, 2014

Study Start

April 14, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

FR(7)