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

2014-08-27 03:14:07 | BioPortfolio

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).

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 Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ulcerative Colitis

Intervention

Close Rectal Dissection - IPAA

Location

Universitair Medical Centre St. Radboud
Nijmegen
Gelderland
Netherlands
6500HB

Status

Recruiting

Source

University Medical Center Nijmegen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:07-0400

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A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.

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