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

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.

Conditions

• Colitis, Ulcerative
• Surgery

Interventions

PROCEDURE

Ileal Neo Rectal Anastomosis

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

PROCEDURE

Ileal Pouch Anal Anastomosis

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

Sponsors & Collaborators

• Radboud University Medical Center

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  lead OTHER

Principal Investigators

• JT Heikens, MD · St Elisabeth Hospital, Tilburg, The Netherlands

• D de Jong, MD, PhD · University Medical Centre St Radboud, Nijmegen, The Netherlands

• JLJM Teepen, MD, PhD · St Elisabeth Hospital, Tilburg, The Netherlands

• JHJM van Krieken, MD, PhD · University Medical Centre St Radboud, The Netherlands

• HG Gooszen, MD, PhD · University Medical Centre St Radboud, Nijmegen, The Netherlands

• J de Vries, Md, PhD · St Elisabeth Hospital, Tilburg, The Netherlands

• CJHM van Laarhoven, MD, PhD · University Medical Centre St Radboud, The Netherlands

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-06-30

Primary Completion

2009-12-31

Completion

2010-07-31

Countries

• Netherlands

Study Locations