Surgery, Colorectal
Conditions
Keywords
SURGERY,, digestive stoma closures
Brief summary
The process of directed healing is a slow one, not without any constraints for patients. In contact with the intestinal flora during the stoma time, the tissues harboring digestive bacteria do not allow direct skin closure without the risk of complications during the restoration of digestive continuity after having to perform an ileal or colonic stoma. Collatamp interposition would allow direct wound closure without additional complications. Various studies have compared directed healing and direct skin closure during stoma closure/restoration of continuity. Overall, directed healing reduces the risk of infection, abscesses, and surgical time, but results in greater constraints for the patient, i.e., longer healing time, more pain, and a poorer cosmetic result compared to direct skin closure.
Interventions
PROCEDUREdigestive stoma closures
Both surgical techniques (Collatamp interposition and directed healing) are routinely used in the CVMC and Digestive Cancer Surgery departments for stoma closure or restoration of digestive continuity. The choice of technique is at the surgeon's discretion. Specific procedures related to the research: Procedures that differ from standard management are randomization and patient completion of a questionnaire.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Interventional research with minimal risks and constraints, not involving a product mentioned in Article L. 5311-1 of the CSP
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Person having received full information on the organization of the research and having signed their informed consent * Patients aged 18 and over * Patients requiring ileostomy or colostomy closure, or restoration of digestive continuity * Person affiliated with a social security scheme or beneficiary of such a scheme
Exclusion criteria
* Patient suffering from an immune deficiency (which would alter the healing process) * Patient unable to complete the questionnaire * Patient with a known intolerance, hypersensitivity, or allergy to aminoglycosides or bovine collagen * Patient suffering from myasthenia gravis * Woman of childbearing age without effective contraception * Person referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code * Pregnant woman, woman in labor, or breastfeeding mother * Minor (non-emancipated) * Adult subject to a legal protection measure (guardianship, curatorship, or legal protection) * Adult unable to express consent . Person deprived of liberty by a judicial or administrative decision, person receiving psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time until complete healing expressed in days | 6 months maximum | Duration of participation of the person participating in the research (including the follow-up period): 6 months maximum Duration of statistical analysis and provision of the final report: 12 months |
Contacts
Primary ContactMatthias MHM Hoeffel-Morgenthaler
Outcome results
None listed