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Completed

NCT Number: NCT02756273

Impact of a Bridge Device on the Loop Ileostomy

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.

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Key information

Conditions

Elective Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rouen, Rouen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bridge Device

Device

no bridge device

Device

Primary outcomes

  1. absence of postoperative morbidity

    Time frame: 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 outcomes

  1. difficulty of the stoma conception

    Time frame: at the end of the surgery

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

  2. the reoperation rate

    Time frame: postoperative month one

    the reoperation rate is defined as the number of reoperation one month after the colorectal surgery

  3. the mortality rate

    Time frame: postoperative month one

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

  4. the postoperative morbidity

    Time frame: postoperative month one

    the postoperative morbidity is defined according the Clavien - Dindo classification and corresponds to the number of patients with a postoperative outcome

  5. the specific quality of life

    Time frame: 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

  6. the rate of stoma closure

    Time frame: 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.

  7. the rate of anastomotic fistula

    Time frame: 2 months after the colorectal surgery

    the rate of anastomotic fistula is defined as the number of anastomotic fistula after the colorectal surgery.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier de Beauvais

Registry information

Acronym: IBIP

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2016
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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