Elective Colorectal SurgeryIBIPNCT02756273
Impact of a Bridge Device on the Loop Ileostomy
A study testing bridge device and no bridge device in people with Elective Colorectal Surgery, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Colorectal Surgery
- What is being tested?
- bridge device and no bridge device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 3 sitesFrance
- Study dates
- 9 May 2016to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease)
- requiring elective surgery with an ileostomy
- patient having given his consent before the enrollment
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Amiens Universitary Hospital
Amiens
Beauvais hospital
Beauvais
Chu Rouen
Rouen, France, 76000
About this study
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
- Being tested
- bridge device, no bridge device
- Keywords
- ileostomy, morbidity, colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bridge deviceDevice
no bridge deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| no bridge device | Experimental | After the ileostomy creation, no bridge device was placed. Receives: Device: no bridge device |
| bridge device | Active comparator | A bridge device was placed after the stoma creation. Receives: Device: bridge device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months after the surgery
Secondary outcomes (7)
difficulty of the stoma conception
the difficulty was assessed by the surgeon thanks to a score ranging from 1 to 10.
Measured: 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
Measured: postoperative month one
the mortality rate
the mortality rate is defined as the number of deaths one month after the surgery
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 2 months after the colorectal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start9 May 2016
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Elective Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais
- Responsible party
- Sponsor
- Investigators
- Charles SABBAGH, Principal investigator, CHU Amiens Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756273
- Sponsor's protocol ID
- PI2015_843_0008
- Other IDs
- 2015-A00620-49, 2015/29
- Acronym
- IBIP
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2016
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 17667498Sagap 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.
PubMed 17011918Panis 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.
PubMed 21997816Oberkofler 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.
PubMed 23095627Cottam 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.
PubMed 17672873Sabbagh 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.
PubMed 40131588
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Bridge Device on the Loop Ileostomy
- ClinicalTrials.gov ID
- NCT02756273
- Acronym / sponsor ID
- IBIP / PI2015_843_0008
- Conditions
- Elective Colorectal Surgery
- Keywords
- ileostomy, morbidity, colorectal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais
- Study start
- 9 May 2016 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no bridge device | Experimental | Device: no bridge deviceAfter the ileostomy creation, no bridge device was placed. |
| bridge device | Active comparator | Device: bridge deviceA bridge device was placed after the stoma creation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease)
- requiring elective surgery with an ileostomy
- patient having given his consent before the enrollment
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bridge device | Device | bridge device |
| no bridge device | Device | no bridge device |
Primary outcome
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.
7 secondary outcomes
difficulty of the stoma conception
Time frame: at the end of the surgery
the reoperation rate
Time frame: postoperative month one
the mortality rate
Time frame: postoperative month one
the postoperative morbidity
Time frame: postoperative month one
the specific quality of life
Time frame: postoperative year one
the rate of stoma closure
Time frame: 6 months after the surgical procedure
the rate of anastomotic fistula
Time frame: 2 months after the colorectal surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 17667498Matthiessen 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.
- Background: PubMed 17011918Sagap 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.
- Background: PubMed 21997816Panis 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.
- Background: PubMed 23095627Oberkofler 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.
- Background: PubMed 17672873Cottam 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.
- Derived from this study: PubMed 40131588Sabbagh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles SABBAGH principal investigator
CHU Amiens Picardie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bridge device and no bridge device in people with Elective Colorectal Surgery, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of postoperative morbidity (time frame: two months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756273, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.