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Laxatives postoperative colorectal surgery.


- candidate number6028
- NTR NumberNTR1883
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jun-2009
- Secondary IDsNL28256.096.09 METC Atrium medisch centrum en Maaslandziekenhuis
- Public TitleLaxatives postoperative colorectal surgery.
- Scientific TitleLaxatives postoperative colorectal surgery.
- ACRONYMLAPOCC
- hypothesisPostoperative ileus is a well-known consequence of abdominal surgery which leads to prolonged hospital stay. Over the past years, the implementation of ERAS programs have lead to a reduction in postoperative hospital stay. The use of laxatives after colorectal surgery within these protocols is not yet evidence based.
The objective of this trial is to compare time to gastrointestinal recovery after elective colorectal surgery between patients treated with a laxative versus patients treated with a placebo.
- Healt Condition(s) or Problem(s) studiedPostoperative ileus, Colorectal surgery, Colorectal pathology
- Inclusion criteriaPatients 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 criteria1. Age <18 years;
2. Emergency procedures;
3. Contra-indications for the laxatives being used;
4. Lacking informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-mei-2010
- Target number of participants215
- InterventionsThe 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 outcomeTime to gastrointestinal recovery, defined as time to first flatus or first defecation.
- Secondary outcomeAppreciation of the laxatives being used, overall hospital stay and incidence of postoperative complications (anastomotic leakage, wound infection, intra-abdominal abscess).
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R.L.G.M. Blom
- CONTACT for SCIENTIFIC QUERIESDr M. Sosef
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsN/A
- Brief summaryPostoperative ileus is a well-known consequence of abdominal surgery which leads to prolonged hospital stay. The objective of this trial is to compare time to gastrointestinal recovery after elective colorectal surgery between patients treated with a laxative versus patients treated with a placebo.
- Main changes (audit trail)
- RECORD26-jun-2009 - 6-okt-2009


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