Clinical trial NCT02756273: Impact of a Bridge Device on the Loop Ileostomy
Official title: Impact of a Bridge Device on the Loop Ileostomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Elective Colorectal Surgery
Keywords: ileostomy
morbidity
colorectal surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Beauvais
First posted: 2016-04-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: absence of postoperative morbidity
timeFrame: two months after the surgery
Secondary outcomes:
measure: difficulty of the stoma conception
timeFrame: at the end of the surgery
measure: the reoperation rate
timeFrame: postoperative month one
measure: the mortality rate
timeFrame: postoperative month one
measure: the postoperative morbidity
timeFrame: postoperative month one
measure: the specific quality of life
timeFrame: postoperative year one
measure: the rate of stoma closure
timeFrame: 6 months after the surgical procedure
measure: the rate of anastomotic fistula
timeFrame: 2 months after the colorectal surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens Universitary Hospital
city: Beauvais
country: France
facility: Beauvais hospital
city: Rouen
country: France
facility: Chu Rouen
Study officials:
affiliation: CHU Amiens Picardie
name: Charles SABBAGH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.