Elective Colorectal Surgery
Conditions
Keywords
ileostomy, morbidity, colorectal surgery
Brief summary
During the creation of an ileostomy, a bridge device is systematically placed in an aim to reduce wound and peritoneal contamination by stools. Nevertheless no evidence was reported to justify this issue. Moreover the placement of a bridge device increases the difficulty of nurse cares and is associated with its own morbidity.
Interventions
DEVICEbridge device
DEVICEno bridge device
Sponsors
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier de Beauvais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease) * requiring elective surgery with an ileostomy * patient having given his consent before the enrollment
Exclusion criteria
* patient with early closure of the stoma (within 10 days after the colorectal surgery) * long term corticoids * emergency surgery * history of stoma in the side of the stoma placement planned for the study * BMI \>50 * No signature of the consent to participate in the study * Physical or mental state not allowing participation in the study * Contraindication to surgery * ASA classification (American Society of Anesthesiologists) IV-V or life expectancy \<48h * Pregnancy or breastfeeding * Patient under guardianship or guardianship or patient deprived of liberty by a judicial or administrative decision (in accordance with articles L1121-6 and L1121-8 of the Public Health Code) * Minor patient * Patient without social protection Peroperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absence of postoperative morbidity | two months after the surgery | the primary outcome is a composite score. The complication is considered as present if the patient experienced at least one of the following events: surgical site infection (either superficial, deep or distant); a parastomal irritation; a stomal necrosis; parastomal hernia; a stoma stenosis; a stoma prolapsus or a stoma leakage. The primary endpoint is evaluated by a nurse devoted to stoma care according to an open label. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difficulty of the stoma conception | at the end of the surgery | the difficulty was assessed by the surgeon thanks to a score ranging from 1 to 10. |
| the reoperation rate | postoperative month one | the reoperation rate is defined as the number of reoperation one month after the colorectal surgery |
| the mortality rate | postoperative month one | the mortality rate is defined as the number of deaths one month after the surgery |
| the postoperative morbidity | postoperative month one | the postoperative morbidity is defined according the Clavien - Dindo classification and corresponds to the number of patients with a postoperative outcome |
| the specific quality of life | postoperative year one | the quality of life is assessed with the STOMA QoL form at Baseline, 2, 6 months after the surgery and one year after the surgery |
| the rate of stoma closure | 6 months after the surgical procedure | the rate of stoma closure is defined as the number of patients for whom the stoma was closed 6 months after the colorectal surgery. |
| the rate of anastomotic fistula | 2 months after the colorectal surgery | the rate of anastomotic fistula is defined as the number of anastomotic fistula after the colorectal surgery. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCharles SABBAGH
CHU Amiens Picardie
Outcome results
None listed