Contact information
Type
Scientific
Primary contact
Dr W.A. Bemelman
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 9111
W.A.Bemelman@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Close Rectal
Study hypothesis
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. These data account for patients who had a proctectomy according to the Total Mesorectal Excision (TME) technique. The Close Rectal Excision (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 long-term 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.
Ethics approval
Ethics approval received from the Medical Ethics Committee AMC, Amsterdam on the 26th April 2006 (ref: MEC 06/061).
Study design
Randomised, double-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ileal pouch anal anastomosis
Intervention
Close rectal dissection of the rectum.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Baseline volume and distensibility of the pouch, measured at least one year after surgery
2. Continence, measured through questionnaires at 1, 3, 6 and 12 months following surgery
3. Quality of life, measured through questionnaires at 1, 3, 6 and 12 months following surgery
Secondary outcome measures
1. Morbidity
2. Blood loss
Overall trial start date
23/06/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Indication for proctocolectomy with construction of ileoanal pouch
2. Ulcerative Colitis or Familial Adenomatous Polyposis
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
1. Aged less than 18 years
2. American Society of Anaesthesiologists (ASA) III/IV
3. (Severe) postoperative complication
4. Emergency procedure
Recruitment start date
23/06/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Surgery
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary