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

NCT03872271 | Unknown

• 2 other identifiers: 2019-042019-A00687-50
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (2)

Experimental

EXPERIMENTAL

ileal pouch-anal anastomosis without diverting loop ileostomy

Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

Control

ACTIVE COMPARATOR

ileal pouch-anal anastomosis with diverting loop ileostomy

Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

Interventions

ileal pouch-anal anastomosis with diverting loop ileastomy PROCEDURE

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.

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 31830976 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Proctocolectomy, Restorative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Colectomy; Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative; Proctectomy

Study Officials

• EMILIE GARRIDO PRADALIE

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Laura BEYER, MD

CONTACT

0491968514; laura.beyer@ap-hm.fr

Amandine Rolland-Brun

CONTACT

0491381245; promotion.interne@ap-hm.fr

Study Design

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

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: November 26, 2019
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)