Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU) (CR-IPAA)
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Purpose
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 | Intervention |
|---|---|
|
Ulcerative Colitis |
Procedure: Close Rectal Dissection - IPAA |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: No ]
- Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Sharonne de Zeeuw, Drs | +31-24-3616421 | s.dezeeuw@chir.umcn.nl |
| 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 | |
| Study Director: | Kees v Laarhoven, prof. dr. | Radboud University |
More Information
No publications provided
| Responsible Party: | Sharonne de Zeeuw, Academic University of Nijmegen |
| ClinicalTrials.gov Identifier: | NCT01111708 History of Changes |
| Other Study ID Numbers: | Close Rectal - IPAA |
| Study First Received: | April 26, 2010 |
| Last Updated: | April 26, 2010 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013