Impact of a Bridge Device on the Loop Ileostomy

Elective Colorectal Surgery Clinical Trial

— IBIP  

Official title:

Impact of a Bridge Device on the Loop Ileostomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02756273
• Other study ID #: PI2015_843_0008
• Secondary ID: 2015-A00620-4920
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2016
• Est. completion date: October 2, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: October 2, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elective Colorectal Surgery

Intervention

Device:
• bridge device

• no bridge device

Locations

Country	Name	City	State
France	Amiens Universitary Hospital	Amiens
France	Beauvais hospital	Beauvais
France	Chu Rouen	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Beauvais

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	the reoperation rate	the reoperation rate is defined as the number of reoperation one month after the colorectal surgery	postoperative month one
Secondary	the mortality rate	the mortality rate is defined as the number of deaths one month after the surgery	postoperative month one
Secondary	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
Secondary	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
Secondary	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
Secondary	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