Impact of a Bridge Device on the Loop Ileostomy

Centre Hospitalier Universitaire, Amiens166 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

166

Conditions

Elective Colorectal Surgery

Interventions

bridge deviceDEVICE

no bridge deviceDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Chu Rouen

Rouen, France, France

Amiens Universitary Hospital

Amiens, France

Beauvais hospital

Beauvais, France

Outcomes

Primary Outcomes

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.

Time frame: two months after the surgery

Secondary Outcomes

difficulty of the stoma conception

the difficulty was assessed by the surgeon thanks to a score ranging from 1 to 10.

Time frame: 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

Time frame: postoperative month one

the mortality rate

the mortality rate is defined as the number of deaths one month after the surgery

Time frame: 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

Time frame: 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

Time frame: postoperative year one

the rate of stoma closure

Data from ClinicalTrials.gov

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