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

C

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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