Clinical trial NCT00922103: A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis, Ulcerative
Surgery
Keywords: Colitis, Ulcerative
Ileo Neo Rectal Anastomosis
Ileal Pouch Anal Anastomosis
Quality of Life
functional results
reconstructive surgery
surgery
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2009-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: functional outcome
timeFrame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
measure: Quality of life and Health Status
timeFrame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Secondary outcomes:
measure: histo-pathologic results
timeFrame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
measure: endoscopic results
timeFrame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
measure: morbidity and mortality
timeFrame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
measure: ano-rectal physiology
timeFrame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: St Elisabeth Hospital
state: Brabant
city: Nijmegen
country: Netherlands
facility: University Medical Centre St Radboud
state: Gelderland
Study officials:
affiliation: St Elisabeth Hospital, Tilburg, The Netherlands
name: JT Heikens, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Centre St Radboud, Nijmegen, The Netherlands
name: D de Jong, MD, PhD
role: STUDY_CHAIR
affiliation: St Elisabeth Hospital, Tilburg, The Netherlands
name: JLJM Teepen, MD, PhD
role: STUDY_CHAIR
affiliation: University Medical Centre St Radboud, The Netherlands
name: JHJM van Krieken, MD, PhD
role: STUDY_CHAIR
affiliation: University Medical Centre St Radboud, Nijmegen, The Netherlands
name: HG Gooszen, MD, PhD
role: STUDY_CHAIR
affiliation: St Elisabeth Hospital, Tilburg, The Netherlands
name: J de Vries, Md, PhD
role: STUDY_CHAIR
affiliation: University Medical Centre St Radboud, The Netherlands
name: CJHM van Laarhoven, MD, PhD
role: STUDY_DIRECTOR
References: