NCT00922103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

4.5 years

First QC Date

June 12, 2009

Last Update Submit

September 10, 2010

Conditions

Colitis, UlcerativeSurgery

Keywords

Colitis, UlcerativeIleo Neo Rectal AnastomosisIleal Pouch Anal AnastomosisQuality of Lifefunctional resultsreconstructive surgerysurgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

INRA

EXPERIMENTAL

Patients treated for medical refractory Ulcerative Colitis

Procedure: Ileal Neo Rectal Anastomosis

IPAA

ACTIVE COMPARATOR

Patients treated for medical refractory Ulcerative Colitis

Procedure: Ileal Pouch Anal Anastomosis

Interventions

Ileal Neo Rectal AnastomosisPROCEDURE

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

INRA
Ileal Pouch Anal AnastomosisPROCEDURE

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

IPAA

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
  • Psychiatric disease or inability to assess follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Centre St Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

St Elisabeth Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Proctocolectomy, Restorative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ColectomySurgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, OperativeProctectomy

Study Officials

  • JT Heikens, MD

    St Elisabeth Hospital, Tilburg, The Netherlands

    PRINCIPAL INVESTIGATOR

  • D de Jong, MD, PhD

    University Medical Centre St Radboud, Nijmegen, The Netherlands

    STUDY CHAIR

  • JLJM Teepen, MD, PhD

    St Elisabeth Hospital, Tilburg, The Netherlands

    STUDY CHAIR

  • JHJM van Krieken, MD, PhD

    University Medical Centre St Radboud, The Netherlands

    STUDY CHAIR

  • HG Gooszen, MD, PhD

    University Medical Centre St Radboud, Nijmegen, The Netherlands

    STUDY CHAIR

  • J de Vries, Md, PhD

    St Elisabeth Hospital, Tilburg, The Netherlands

    STUDY CHAIR

  • CJHM van Laarhoven, MD, PhD

    University Medical Centre St Radboud, The Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 17, 2009

Study Start

June 1, 2005

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

NL(2)