|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR1883 |
|
Date of registration:
|
26/06/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Laxatives postoperative colorectal surgery.
|
|
Scientific title:
|
Laxatives postoperative colorectal surgery. - LAPOCC |
|
Date of first enrolment:
|
1/7/2009 |
|
Target sample size:
|
215 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1883 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
M.
Sosef |
|
Address:
|
Atrium MC Heerlen
Chirurgie, Postbus 4446
6401 CX
Heerlen
The Netherlands |
|
Telephone:
|
+31 45 576 66 66 |
|
Email:
|
meindert.sosef@planet.nl |
|
Affiliation:
|
|
|
|
Name:
|
R.L.G.M.
Blom |
|
Address:
|
Postbus 4446, Atrium MC Heerlen afdeling chirurgie, Henri Dunantstraat 5
6401 CX
Heerlen
The Netherlands |
|
Telephone:
|
+31 (0)45-5766666 |
|
Email:
|
r.blom@student.maastrichtuniversity.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients planned for elective colorectal surgery will be included regardless of age, underlying pathology or co-morbidity. Procedures to be performed include right hemicolectomy, transversectomy, left-hemicolectomy, sigmoid resection, low anterior resection, polypectomy, abdominoperineal resection, and laparoscopic right or left hemicolectomy.
Exclusion criteria: 1. Age <18 years;
2. Emergency procedures;
3. Contra-indications for the laxatives being used;
4. Lacking informed consent.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Postoperative ileus, Colorectal surgery, Colorectal pathology
|
|
Intervention(s)
|
|
The laxatives being used in this trial are magnesiumoxide and bisacodyl. Patients will receive the laxative or the placebo for three days postoperatively, twice daily starting on the evening of surgery.
|
|
Primary Outcome(s)
|
|
Time to gastrointestinal recovery, defined as time to first flatus or first defecation.
|
|
Secondary Outcome(s)
|
|
Appreciation of the laxatives being used, overall hospital stay and incidence of postoperative complications (anastomotic leakage, wound infection, intra-abdominal abscess).
|
|
Secondary ID(s)
|
|
NL28256.096.09
|
|
Source(s) of Monetary Support
|
|
Atrium Medisch Centrum Parkstad
|
|