Condition category
Surgery
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
26/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes