Impact of a Bridge Device on the Loop Ileostomy (IBIP)

Centre Hospitalier Universitaire, Amiens

Status: Active, not recruiting

Conditions: Elective Colorectal Surgery

Treatments: Device: no bridge device; Device: bridge device

Study type: Interventional

Funder types: Other

Identifiers

NCT02756273

2015-A00620-49 (Other Identifier)

2015/29 (Other Identifier)

PI2015_843_0008

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

no bridge device

Experimental group

Description:

After the ileostomy creation, no bridge device was placed.

Treatment:

Device: no bridge device

bridge device

Active Comparator group

Description:

A bridge device was placed after the stoma creation.

Treatment:

Device: bridge device