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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Close Rectal-Ileo Pouch Anal Anastomosis

Group Type EXPERIMENTAL

Close Rectal Dissection - IPAA

Intervention Type PROCEDURE

Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis

Conventional Ileo Pouch Anal Anastomosis

Group Type ACTIVE_COMPARATOR

Close Rectal Dissection - IPAA

Intervention Type PROCEDURE

Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis

Ileo Neo Rectal Anastomosis

Group Type ACTIVE_COMPARATOR

Close Rectal Dissection - IPAA

Intervention Type PROCEDURE

Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis

Interventions

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Close Rectal Dissection - IPAA

Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis

Intervention Type PROCEDURE

Other Intervention Names

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INRA, IPAA, restorative surgery

Eligibility Criteria

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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.