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Proctocolectomy and Ileal Pouch Anal Anastomosis-Total Mesorectal Excision versus Close Rectal Excision-


- candidate number2670
- NTR NumberNTR1026
- ISRCTNISRCTN35140084
- Date ISRCTN created23-aug-2007
- date ISRCTN requested13-aug-2007
- Date Registered NTR23-jul-2007
- Secondary IDs 
- Public TitleProctocolectomy and Ileal Pouch Anal Anastomosis-Total Mesorectal Excision versus Close Rectal Excision-
- Scientific TitleProctocolectomy and Ileal Pouch Anal Anastomosis-Total Mesorectal Excision versus Close Rectal Excision-
- ACRONYMClose Rectal
- hypothesisNot much is known about the function of the pouch in relation to the space in which it is situated. At the time of construction the pouch will have a volume of +100 ml expanding over time towards its final volume + 300 ml. (13) These data account for patients who had a proctectomy according to the TME technique. The CRE technique leaves the mesorectum in place in contrast to the TME. Theoretically, the pouch does have less space for distension. It is not known how the two techniques effect longterm pouch volume and whether this result in a difference in pouch function. The objective of this study is to evaluate the baseline volume and distensibility of the pouch, and pouch function in patients having had restorative proctocolectomy either applying a close rectal dissection or a total mesorectal excision technique to extirpate the rectum.
- Healt Condition(s) or Problem(s) studiedEmollients, Proctocolectomy, Inflammatory bowel disease, Familial adenomatous polyposis (FAP), Ileoanal pouch anastomosis, Rectal dissection, Total mesorectal excision (TME)
- Inclusion criteria1. Indication for proctocolectomy with construction of ileoanal pouch; 2. Ulcerative Colitis or Familial Adenomatous Polyposis; 3. Informed consent
- Exclusion criteria1. Age< 18 years; 2. ASA III/IV; 3. (Severe) postoperative complication; 4. Emergency procedure
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 23-jun-2006
- planned closingdate1-jul-2008
- Target number of participants30
- InterventionsClose rectal dissection of the rectum
- Primary outcome1. Baseline volume and distensibility of the pouch; 2. Continence; 3. Quality of life
- Secondary outcome1. Morbidity; 2. Blood loss
- Timepoints
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.A. Bemelman
- CONTACT for SCIENTIFIC QUERIESMD P.J. Koperen, van
- Sponsor/Initiator Academic Medical Center (AMC), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Surgery
- Publicationsn/a
- Brief summaryIntroduction: Restorative proctocolectomy and Ileal Pouch Anal Anastomosis is the preferred approach to treat Ulcerative Colitis (UC) and Familial Adenomatous Polyposis (FAP) surgically. The rectum extirpation can be done applying a total mesorectal excision technique or a close rectal dissection leaving the complete mesorectum in place. Objectives: The objective of this study is to evaluate the baseline volume and distensibility of the pouch, and pouch function in patients having had restorative proctocolectomy either applying a close rectal dissection or a total mesorectal excision technique to extirpate the rectum. Patient and methods: Thirty patients eligible for proctocolectomy for CU and FAP will be randomised for Total Mesorectal Excision or Close Rectal Excision. Primary outcome parameters are pouchcharacteristics measured by Barostat and pouch function viz continence and quality of life measured by questionnaires (SF-36 and GIQLE). Secondary parameters are morbidity, duration of surgery and blood loss.
- Main changes (audit trail)
- RECORD23-jul-2007 - 27-aug-2007


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