|- candidate number||8633|
|- NTR Number||NTR2594|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-nov-2010|
|- Secondary IDs||P10-152 / 10-146; METC LUMC / METC Zuid West Holland|
|- Public Title||Gum chewing and postoperative ileus.|
|- Scientific Title||Gum chewing and postoperative ileus.|
|- ACRONYM||De kauwgomstudie|
|- hypothesis||The objective of this trial is to compare time to gastrointestinal recovery after elective abdominal surgery between patients treated with a gum chewing versus patients with standard postoperative care.|
|- Healt Condition(s) or Problem(s) studied||Postoperative ileus, Abdominal surgery, fast track care, Gum chewing|
|- Inclusion criteria||1. Laparotomy by any indication;|
2. Laparoscopic intestinal surgery.
|- Exclusion criteria||1. Age <18 years;|
2. Emergency surgery;
3. Lacking informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2010|
|- planned closingdate||1-dec-2012|
|- Target number of participants||2000|
|- Interventions||Gum chewing will be started directly postoperatively, 3 times a day for 30 minutes.|
The control group will receive care as usual.
|- Primary outcome||Time of hospital stay.|
|- Secondary outcome||1. Time to first defecation;|
2. Time to first flatus;
|- Timepoints||Start directly postoperative, complications are reported untill 30 days postoperatively.|
|- Trial web site||www.kauwgomstudie.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. N.J. Leersum, van|
|- CONTACT for SCIENTIFIC QUERIES||Drs. N.J. Leersum, van|
|- Sponsor/Initiator ||Medical Center Haaglanden, Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC), Maatschap Heelkunde Medisch Centrum Haaglanden|
|- Brief summary||Postoperative 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 gum chewing after abdominal surgery is not yet evidence based, nor implemented in these protocols.
The objective of this trial is to compare time to gastrointestinal recovery after elective abdominal surgery between patients treated with a gum chewing versus patients with standard postoperative care.
|- Main changes (audit trail)||12-mrt-2015: status gewijzigd: gesloten onderzoek afgerond-EB|
|- RECORD||7-nov-2010 - 12-mrt-2015|