Not 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…
ID
Bron
Verkorte titel
Aandoening
Ulcerative Colitis, Inflammatory Bowel Disease, FAP, Proctocolectomy, IPAA, ileoanal pouch anastomosis, pouch, Close Rectal dissection, TME.
Colitis Ulcerosa, Inflammatoire darmziekten, FAP, Proctocolectomy, ileoanale pouch, close rectal dissectie, Totale mesorectale excisie
Ondersteuning
Department of Surgery
Amsterdam
Department of Surgery
Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Baseline volume and distensibility of the pouch;
2. Continence;
3. Quality of life
Achtergrond van het onderzoek
Introduction:
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.
Doel van het onderzoek
Not 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.
Onderzoeksproduct en/of interventie
Close rectal dissection of the rectum
Publiek
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
W.A. Bemelman
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)6 30023579
W.A.Bemelman@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Indication for proctocolectomy with construction of ileoanal pouch;
2. Ulcerative Colitis or Familial Adenomatous Polyposis;
3. Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age< 18 years;
2. ASA III/IV;
3. (Severe) postoperative complication;
4. Emergency procedure
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL997 |
NTR-old | NTR1026 |
Ander register | : |
ISRCTN | ISRCTN35140084 |