Comparing Two Reconstruction Methods After Colectomy in Adults With Ulcerative Colitis in Sweden and England
Led by Linkoeping University · Updated on 2022-11-29
100
Participants Needed
4
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing two main surgical reconstruction options after colectomy for adult patients with ulcerative colitis ileal pouch anal anastomosis IPAA and ileorectal anastomosis IRA. This study aims to provide detailed information on patient satisfaction, quality of life, function, and complications between these two approaches, addressing a gap due to lack of prospective randomized trials. Patients are informed and choose their preferred surgery, with some followed as controls based on eligibility or choice to decline reconstruction.
Participants who are eligible for both procedures choose either IPAA or IRA, while others may only qualify for one method or decline reconstruction and keep an ileostomy. The study includes multiple groups those selecting either surgery, those eligible for only one, and those who decline reconstruction. The surgeries involve either connecting the ileum to the rectum IRA or creating a pouch from the ileum connected to the anus IPAA. Patients are followed over time to assess outcomes.
During the study, patient satisfaction is measured at 2 months, 1 year, and 5 years after surgery. Additional assessments include quality of life surveys, sexual function indexes for females and males, health scales, and scores related to bowel function. Researchers also monitor complications such as failure and reoperations at multiple time points. The study spans long-term follow-up to evaluate the impact of each reconstructive method on patient well-being and function.
CONDITIONS
Brief Title
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
Research Team
A
Anton Risto
P
Pär Myrelid, Prof.
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Varies per participant
Participants undergo surgery to reconstruct the bowel with either ileorectal anastomosis, ileal pouch-anal anastomosis, or continue with ileostomy, followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Post-operative Follow-up
Duration - Up to 5 years
Participants are followed up after surgery to monitor recovery, complications, and patient satisfaction.
Multiple visits at 2 months, 6 months, 1 year, 2 years, and 5 years
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Similar Trials
Study to Identify Targets of Disease-Related T Cells in Adults with Autoimmune Diseases
Long-term Safety Study of Oral Zasocitinib TAK-279 for Adults With Moderate to Severe Ulcerative Colitis and Crohns Disease
Study of Disease Patterns, Treatments, and Healthcare Use in Children Under 18 With Inflammatory Bowel Diseases in Korea
Long-Term Safety Study of Vedolizumab Injections in Children and Teens With Ulcerative Colitis or Crohns Disease
Phase 3 Study Evaluating the Safety and Effectiveness of Duvakitug in Adults and Older Teens With Moderate to Severe Ulcerative Colitis
Long-term Mirikizumab Treatment Study for Children and Teens with Moderate-to-Severe Ulcerative Colitis or Crohns Disease
Phase 2 Study of MORF-057 Treatment for Adults with Moderate to Severe Crohns Disease
Safety Monitoring of Ozanimod Treatment in Korean Adults with Moderate to Severe Ulcerative Colitis
Real-World Study of Treat-to-Target Strategy and Disease Management in Adults with Crohns Disease and Ulcerative Colitis
Evaluation of Rectal Administration of a Specific Probiotic to Improve Gut Health in Adults with Mild-to-Moderate Ulcerative Colitis
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Colectomy reconstruction for ulcerative colitis in Sweden and England: a multicenter prospective comparison between ileorectal anastomosis and ileal pouch-anal anastomosis after colectomy in patients with ulcerative colitis. (CRUISE-study).
Anton Risto, Caroline Nordenvall, Mohammed Deputy...