Ulcerative ColitisIDEALNCT03872271
Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial
A study testing ileal pouch-anal anastomosis with diverting loop ileastomy in people with Ulcerative Colitis and Ileostomy - Stoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Ileostomy - Stoma
- What is being tested?
- ileal pouch-anal anastomosis with diverting loop ileastomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2019to 24 May 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
- patients aged ≥ 18 years,
- patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
- patients who have given informed consent
Who cannot join
- indication for total proctocolectomy in one-stage or traditional 2-stage fashion
- Crohn's disease,
- pelvic radiotherapy,
- indication for total mésorectum excision
- vulnerable patient under the French laws
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Laura Beyer, MD, laura.beyer@ap-hm.fr
About this study
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
Total proctocolectomy with IPAA is the gold standard for surgical management of ulcerative colitis (UC). This demanding procedure is often performed in 2 or 3 stages, namely subtotal colectomy, completion proctectomy with IPAA and defunctioning ileostomy closure. Subtotal colectomy with double stoma is first performed to allow nutritional support, reduce inflammation and stop immunosuppressive agents. Completion proctectomy with IPAA is then performed on a healthier patient. Hence, the need for a systematic defunctioning ileostomy is questioned. No study addressed specifically the question of completion proctectomy, whereas it concerns 36% to 42% of patients undergoing IPAA. Globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30% otherwise in IPAA.
Read more
Moreover, defunctioning ileostomy has several drawbacks including an additional surgical procedure (stoma closure), a worse quality of life before closure, and the risk of dehydration that may require readmission. Following stoma closure, the risk of anastomotic leakage is around 4%. Overall, during the stoma period, 8% of patients will require reoperation. Finally, the risk of incisional hernia is 15-20% at the ex-ileostomy site.
Therefore, the aim of this trial is to assess the need for a systematic defunctioning ileostomy after completion proctectomy with IPAA.
- Conditions
- Ulcerative Colitis, Ileostomy - Stoma
- Being tested
- ileal pouch-anal anastomosis with diverting loop ileastomy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileal pouch-anal anastomosis with diverting loop ileastomyProcedure or surgery
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
ileal pouch-anal anastomosis with diverting loop ileastomyProcedure or surgery
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | ileal pouch-anal anastomosis without diverting loop ileostomy Receives: Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy |
| Control | Active comparator | ileal pouch-anal anastomosis with diverting loop ileostomy Receives: Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month global postoperative morbidity
Number and qualification of surgical and medical complications that may require redmission during the 6 months following the operative procedure:
- SBO
- ileostomy prolapse
- parastomial hernia
- dehydration
- skin erosions, that may require readmission
- anastomotic leakage
- incisional hernia.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start26 Nov 2019
- Primary completion24 May 2024 (estimated)
- Study completion24 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872271
- Sponsor's protocol ID
- 2019-04
- Other IDs
- 2019-A00687-50
- Acronym
- IDEAL
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beyer-Berjot L, Baumstarck K, Loubiere S, Vicaut E, Berdah SV, Benoist S, Lefevre JH; GETAID Chirurgie group. Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271). BMC Surg. 2019 Dec 12;19(1):192. doi: 10.1186/s12893-019-0657-7.
PubMed 31830976
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial
- ClinicalTrials.gov ID
- NCT03872271
- Acronym / sponsor ID
- IDEAL / 2019-04
- Conditions
- Ulcerative Colitis, Ileostomy - Stoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 24 May 2024 (estimated)
- Study completion
- 24 May 2025 (estimated)
- First posted
- 13 Mar 2019 (actual)
- 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.
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
Total proctocolectomy with IPAA is the gold standard for surgical management of ulcerative colitis (UC). This demanding procedure is often performed in 2 or 3 stages, namely subtotal colectomy, completion proctectomy with IPAA and defunctioning ileostomy closure. Subtotal colectomy with double stoma is first performed to allow nutritional support, reduce inflammation and stop immunosuppressive agents. Completion proctectomy with IPAA is then performed on a healthier patient. Hence, the need for a systematic defunctioning ileostomy is questioned. No study addressed specifically the question of completion proctectomy, whereas it concerns 36% to 42% of patients undergoing IPAA. Globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30% otherwise in IPAA.
Moreover, defunctioning ileostomy has several drawbacks including an additional surgical procedure (stoma closure), a worse quality of life before closure, and the risk of dehydration that may require readmission. Following stoma closure, the risk of anastomotic leakage is around 4%. Overall, during the stoma period, 8% of patients will require reoperation. Finally, the risk of incisional hernia is 15-20% at the ex-ileostomy site.
Therefore, the aim of this trial is to assess the need for a systematic defunctioning ileostomy after completion proctectomy with IPAA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: ileal pouch-anal anastomosis with diverting loop ileastomyileal pouch-anal anastomosis without diverting loop ileostomy |
| Control | Active comparator | Procedure: ileal pouch-anal anastomosis with diverting loop ileastomyileal pouch-anal anastomosis with diverting loop ileostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged ≥ 18 years,
- patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
- patients who have given informed consent
Key exclusion criteria (5 listed)
- indication for total proctocolectomy in one-stage or traditional 2-stage fashion
- Crohn's disease,
- pelvic radiotherapy,
- indication for total mésorectum excision
- vulnerable patient under the French laws
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 |
|---|---|---|
| ileal pouch-anal anastomosis with diverting loop ileastomyDefunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy. | Procedure or surgery | Control |
| ileal pouch-anal anastomosis with diverting loop ileastomyDefunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy. | Procedure or surgery | Experimental |
Primary outcome
6-month global postoperative morbidity
Time frame: 6 months
Number and qualification of surgical and medical complications that may require redmission during the 6 months following the operative procedure: * SBO * ileostomy prolapse * parastomial hernia * dehydration * skin erosions, that may require readmission * anastomotic leakage * incisional hernia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 31830976Beyer-Berjot L, Baumstarck K, Loubiere S, Vicaut E, Berdah SV, Benoist S, Lefevre JH; GETAID Chirurgie group. Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271). BMC Surg. 2019 Dec 12;19(1):192. doi: 10.1186/s12893-019-0657-7.
- Individual participant dataSharing planned: Undecided
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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.
EMILIE GARRIDO PRADALIE study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ileal pouch-anal anastomosis with diverting loop ileastomy in people with Ulcerative Colitis and Ileostomy - Stoma, run by Assistance Publique Hopitaux De Marseille at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura BEYER, MD (0491968514, laura.beyer@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month global postoperative morbidity (time frame: 6 months). 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 NCT03872271, which also lists 1 linked publication.
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 8 Feb 2023.