Ileostomy - Stoma, Ulcerative Colitis
Conditions
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.
Interventions
PROCEDUREileal 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.
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactLaura BEYER, MD
Backup ContactAmandine Rolland-Brun
Outcome results
None listed