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

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ClinicalTrials.gov Identifier: NCT01111708
Recruitment Status : Unknown
Verified January 2010 by University Medical Center Nijmegen.
Recruitment status was:  Recruiting
First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
University Medical Center Nijmegen

Brief Summary:
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 or disease Intervention/treatment Phase
Ulcerative Colitis Procedure: Close Rectal Dissection - IPAA Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2010
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology. [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sharonne de Zeeuw, Academic University of Nijmegen
ClinicalTrials.gov Identifier: NCT01111708     History of Changes
Other Study ID Numbers: Close Rectal - IPAA
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: January 2010

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