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

Not Applicable

• Conditions: Ulcerative Colitis
• Interventions: Procedure: Close Rectal Dissection - IPAA

• Registration Number: NCT01111708
• Lead Sponsor: 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).

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 Timeline

• Status Verified: 2010-01
• Study Start: 2010-04
• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-26
• Last Update Submitted: 2010-04-26
• Study First Posted: 2010-04-27
• Last Update Posted: 2010-04-27
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Close Rectal-Ileo Pouch Anal Anastomosis	Close Rectal Dissection - IPAA	-
Conventional Ileo Pouch Anal Anastomosis	Close Rectal Dissection - IPAA	-
Ileo Neo Rectal Anastomosis	Close Rectal Dissection - IPAA	-

Primary Outcome Measures

Name	Time	Method
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.	1 year

Secondary Outcome Measures

Name	Time	Method
Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.	1 year

Trial Locations

Locations (1)

Universitair Medical Centre St. Radboud; 🇳🇱 Nijmegen, Gelderland, Netherlands