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Completed

NCT Number: NCT00922103

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

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Surgery

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre St Radboud, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ileal Neo Rectal Anastomosis

Procedure

Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis

Ileal Pouch Anal Anastomosis

Procedure

Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis

Primary outcomes

  1. functional outcome

    Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards

  2. Quality of life and Health Status

    Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards

Secondary outcomes

  1. histo-pathologic results

    Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards

  2. endoscopic results

    Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards

  3. morbidity and mortality

    Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards

  4. ano-rectal physiology

    Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards

Sponsors and collaborators

Lead sponsor

Elisabeth-TweeSteden Ziekenhuis

Other

Collaborators

  • Radboud University Medical Center

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jun 17, 2009
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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