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

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 Overview

• Status: Active, not recruiting
• Conditions: Elective Colorectal Surgery
• Intervention / Treatment: Device: no bridge device; Device: bridge device

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Amiens Universitary Hospital
  • Beauvais, France
    • Beauvais hospital
  • Rouen, France, 76000
    • CHU Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier de Beauvais
• Investigators: Principal Investigator: Charles SABBAGH, CHU Amiens Picardie

Publications and helpful links

General Publications

• Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
• Sagap I, Remzi FH, Hammel JP, Fazio VW. Factors associated with failure in managing pelvic sepsis after ileal pouch-anal anastomosis (IPAA)--a multivariate analysis. Surgery. 2006 Oct;140(4):691-703; discussion 703-4. doi: 10.1016/j.surg.2006.07.015.
• Panis Y, Maggiori L, Caranhac G, Bretagnol F, Vicaut E. Mortality after colorectal cancer surgery: a French survey of more than 84,000 patients. Ann Surg. 2011 Nov;254(5):738-43; discussion 743-4. doi: 10.1097/SLA.0b013e31823604ac.
• Oberkofler CE, Rickenbacher A, Raptis DA, Lehmann K, Villiger P, Buchli C, Grieder F, Gelpke H, Decurtins M, Tempia-Caliera AA, Demartines N, Hahnloser D, Clavien PA, Breitenstein S. A multicenter randomized clinical trial of primary anastomosis or Hartmann's procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg. 2012 Nov;256(5):819-26; discussion 826-7. doi: 10.1097/SLA.0b013e31827324ba.
• Cottam J, Richards K, Hasted A, Blackman A. Results of a nationwide prospective audit of stoma complications within 3 weeks of surgery. Colorectal Dis. 2007 Nov;9(9):834-8. doi: 10.1111/j.1463-1318.2007.01213.x. Epub 2007 Aug 2.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2016
• Primary Completion (Actual): May 1, 2022
• Study Completion (Estimated): October 2, 2023

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimated): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ileostomy; colorectal surgery; morbidity
• Other Study ID Numbers: PI2015_843_0008; 2015-A00620-49 (Other Identifier: ANSM); 2015/29 (Other Identifier: CPP Nord Ouest II)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO