Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU) (CR-IPAA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Medical Center Nijmegen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01111708
First received: April 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).


Condition Intervention
Ulcerative Colitis
Procedure: Close Rectal Dissection - IPAA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa Compared to the Ileo Neo Rectal Anastomosis and the Ileo Pouch Anal Anastomosis

Resource links provided by NLM:


Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Close Rectal-Ileo Pouch Anal Anastomosis Procedure: Close Rectal Dissection - IPAA
Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
Other Name: INRA, IPAA, restorative surgery
Active Comparator: Conventional Ileo Pouch Anal Anastomosis Procedure: Close Rectal Dissection - IPAA
Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
Other Name: INRA, IPAA, restorative surgery
Active Comparator: Ileo Neo Rectal Anastomosis Procedure: Close Rectal Dissection - IPAA
Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
Other Name: INRA, IPAA, restorative surgery

Detailed Description:

Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The surgery rate after 10 years is 30%. After (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. The conventional ileo pouch anal anastomosis (C-IPAA) is the gold standard of reconstructive surgery. This is al well established technique, but still carries a significant morbidity-rate. The recent studied ileo neo rectal anastomosis (INRA) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. Therefore, we want to investigate an alternative technique: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). The CR-IPAA is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. After the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. The close rectal dissection (CRD) is very laborious and has therefore never been developed extensively. But recent technical development of electrothermal bipolar vessel sealer (EBVS ) and ultrasound dissection have enhanced the CRD technique enormously. This brought along new interest in the CRD and justifies the research of its application.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • UC patients with the CRD procedure with written informed consent.
  • Age, sex and disease specific matched control group op UC-IPAA patients with written informed consent.

Exclusion Criteria:

  • Pregnancy
  • Malignancy
  • Psychiatric disease or inability to assess follow-up
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111708

Contacts
Contact: Sharonne de Zeeuw, Drs +31-24-3616421 s.dezeeuw@chir.umcn.nl

Locations
Netherlands
Universitair Medical Centre St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Sharonne de Zeeuw, Drs    0031-24-3616421    s.dezeeuw@chir.umcn.nl   
Principal Investigator: Sharonne de Zeeuw, Drs         
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
Study Director: Kees v Laarhoven, prof. dr. Radboud University
  More Information

No publications provided

Responsible Party: Sharonne de Zeeuw, Academic University of Nijmegen
ClinicalTrials.gov Identifier: NCT01111708     History of Changes
Other Study ID Numbers: Close Rectal - IPAA
Study First Received: April 26, 2010
Last Updated: April 26, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014