Impact of a Bridge Device on the Loop Ileostomy

Study Overview
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Brief Summary
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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.

Official Title
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Impact of a Bridge Device on the Loop Ileostomy

Conditions
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Elective Colorectal Surgery

Intervention / Treatment
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* Device: bridge device
* Device: no bridge device


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: no anastomosis no ileostomy Spontaneous stomal retraction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no bridge device<br>After the ileostomy creation, no bridge device was placed. | Device: no bridge device<br> <br> |
| Active Comparator: bridge device<br>A bridge device was placed after the stoma creation. | Device: bridge device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence of postoperative morbidity | 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. | two months after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difficulty of the stoma conception | the difficulty was assessed by the surgeon thanks to a score ranging from 1 to 10. | at the end of the surgery | 
| the reoperation rate | the reoperation rate is defined as the number of reoperation one month after the colorectal surgery | postoperative month one | 
| the mortality rate | the mortality rate is defined as the number of deaths one month after the surgery | postoperative month one | 
| the postoperative morbidity | the postoperative morbidity is defined according the Clavien - Dindo classification and corresponds to the number of patients with a postoperative outcome | postoperative month one | 
| the specific quality of life | 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 | postoperative year one | 
| the rate of stoma closure | the rate of stoma closure is defined as the number of patients for whom the stoma was closed 6 months after the colorectal surgery. | 6 months after the surgical procedure | 
| the rate of anastomotic fistula | the rate of anastomotic fistula is defined as the number of anastomotic fistula after the colorectal surgery. | 2 months after the colorectal surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ileostomy, morbidity, colorectal surgery