Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03872271

Collaborator

(none)

194

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Ileostomy - Stoma	Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental ileal pouch-anal anastomosis without diverting loop ileostomy	Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy 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.
Active Comparator: Control ileal pouch-anal anastomosis with diverting loop ileostomy	Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy 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.

Arm

Intervention/Treatment

Experimental: Experimental

ileal pouch-anal anastomosis without diverting loop ileostomy

Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

Active Comparator: Control

ileal pouch-anal anastomosis with diverting loop ileostomy

Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

Outcome Measures

Primary Outcome Measures

6-month global postoperative morbidity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients aged ≥ 18 years,
patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
patients who have given informed consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: EMILIE GARRIDO PRADALIE, AP-HM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT03872271

Other Study ID Numbers:

2019-04
2019-A00687-50

First Posted:

Mar 13, 2019

Last Update Posted:

Mar 13, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Study Results

No Results Posted as of Mar 13, 2019