Impact of a Bridge Device on the Loop Ileostomy

NCT02756273 | Unknown

• 3 other identifiers: PI2015_843_00082015-A00620-492015/29
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

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.

Conditions

Elective Colorectal Surgery

Keywords

ileostomy; morbidity; colorectal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• difficulty of the stoma conception

  at the end of the surgery

• the reoperation rate

  postoperative month one

• the mortality rate

  postoperative month one

• the postoperative morbidity

  postoperative month one

• the specific quality of life

  postoperative year one

Study Arms (2)

no bridge device

EXPERIMENTAL

After the ileostomy creation, no bridge device was placed.

Device: no bridge device

bridge device

ACTIVE COMPARATOR

A bridge device was placed after the stoma creation.

Device: bridge device

Interventions

bridge device DEVICE

bridge device

no bridge device DEVICE

no bridge device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease)
• requiring elective surgery with an ileostomy
• patient having given his consent before the enrollment

You may not qualify if:

• 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
• no anastomosis
• no ileostomy

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier de Beauvais: collaborator

Study Sites (3)

Amiens Universitary Hospital

Amiens, France

Location

Beauvais hospital

Beauvais, France

Location

Chu Rouen

Rouen, 76000, France

Location

Related Publications (6)

• 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.

  PMID: 17667498 BACKGROUND

• 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.

  PMID: 17011918 BACKGROUND

• 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.

  PMID: 21997816 BACKGROUND

• 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.

  PMID: 23095627 BACKGROUND

• 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.

  PMID: 17672873 BACKGROUND

• Sabbagh C, Mauvais F, Demouron M, Browet F, Tartar L, Hariz H, Bridoux V, Tuech JJ, Diouf M, Regimbeau JM. Is a bridge (rod) necessary for loop ileostomy? A phase II randomized control trial. Tech Coloproctol. 2025 Mar 25;29(1):87. doi: 10.1007/s10151-025-03132-4.

  PMID: 40131588 DERIVED

Study Officials

• Charles SABBAGH

  CHU Amiens Picardie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: April 29, 2016
• Study Start: May 10, 2016
• Primary Completion: May 1, 2022
• Study Completion: October 2, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)