ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery

Summary

Ulcerative colitis (UC) is a chronic intestinal disease, often debuting early in life, and affecting the colon and rectum. The therapy is mainly medical and based on 5-aminosalicylic acid (5-ASA) and steroids. The last 20 years numerous new advanced therapies have become available and introduced more and more early after diagnosis. Surgery is still needed in refractory disease and will cure most patients, while ending up with a stoma. There is conflicting data on whether advanced therapies are decreasing the need for surgery or not.

Reconstruction of bowel continuity is usually possible but somehow performed in less than 50% of Swedish patients. Restorative proctectomy with ileal pouch (created of the last part of the small bowel) anal anastomosis (IPAA) is gold standard. As of this year it is centralized to 4 units in Sweden.

One complication after IPAA is pouchitis, an inflammation in the pouch that behaves like UC. More than half of all patients will have at least one flare of pouchitis, and some will develop chronic or recurrent pouchitis. Recent publications have shown an increased risk of pouchitis after the introduction of advanced therapies, but the reasons for this are still unknown. Prophylactic therapy with 5-ASA after IPAA surgery have been suggested.

All patients in Sweden going through IPAA surgery due to UC will be invited to be part of this randomized controlled study to evaluate if 5-ASA can diminish the risk of pouchitis in UC.

Conditions

• Ulcerative Colitis (UC)
• Pouchitis

Interventions

DRUG

5-ASA

Topical prophylactic treatment of pouchitis after restorative proctocolectomy

DRUG

Placebo

Topical placebor after restorative påroctocolectomy

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Region Örebro County

  collaborator OTHER

• Örebro University, Sweden

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Östra Hospital

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Lund University

  collaborator OTHER

• University Hospital, Linkoeping

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-04-01

Primary Completion

2031-03-31

Completion

2031-03-31

Countries

• Sweden

Study Locations