A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.

Detailed Description
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This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not. The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before. The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.

Official Title
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A Historical Cohort Study, to Investigate Morbidity, Functional and Physiological Outcome, as Well as Endoscopic and Histological Aspects and the Quality of Life, of the Ileo Neo Rectal Anastomosis (INRA) Compared to the Ileo Pouch Anal Anastomosis (IPAA), for Patients With Ulcerative Colitis (UC)

Conditions
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Colitis, Ulcerative, Surgery

Intervention / Treatment
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* Procedure: Ileal Neo Rectal Anastomosis
* Procedure: Ileal Pouch Anal Anastomosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UC patients with INRA procedure Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period Written informed consent Exclusion criteria Pregnancy Malignancy (apart from basalioma or carcinoma-in-situ of cervix) Psychiatric disease or inability to assess follow up

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INRA<br>Patients treated for medical refractory Ulcerative Colitis | Procedure: Ileal Neo Rectal Anastomosis<br>* Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis<br>|
| Active Comparator: IPAA<br>Patients treated for medical refractory Ulcerative Colitis | Procedure: Ileal Pouch Anal Anastomosis<br>* Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcome |  | after surgery: 3 months, 6 months, 12 months and yearly afterwards | 
| Quality of life and Health Status |  | after surgery: 3 months, 6 months, 12 months and yearly afterwards | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histo-pathologic results |  | after surgery: 3 months, 6 months, 12 months and yearly afterwards | 
| endoscopic results |  | after surgery: 3 months, 6 months, 12 months and yearly afterwards | 
| morbidity and mortality |  | after surgery: 3 months, 6 months, 12 months and yearly afterwards | 
| ano-rectal physiology |  | after surgery: 3 months, 6 months, 12 months and yearly afterwards | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colitis, Ulcerative, Ileo Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis, Quality of Life, functional results, reconstructive surgery, surgery