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

University Medical Center Nijmegen

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Procedure: Close Rectal Dissection - IPAA

Study type: Interventional

Funder types: Other

Identifiers

NCT01111708

Close Rectal - IPAA

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Close Rectal-Ileo Pouch Anal Anastomosis

Experimental group

Treatment:

Procedure: Close Rectal Dissection - IPAA

Conventional Ileo Pouch Anal Anastomosis

Active Comparator group

Treatment:

Procedure: Close Rectal Dissection - IPAA

Ileo Neo Rectal Anastomosis

Active Comparator group

Treatment:

Procedure: Close Rectal Dissection - IPAA