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Gum chewing and postoperative ileus.


- candidate number8633
- NTR NumberNTR2594
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-nov-2010
- Secondary IDsP10-152 / 10-146; METC LUMC / METC Zuid West Holland
- Public TitleGum chewing and postoperative ileus.
- Scientific TitleGum chewing and postoperative ileus.
- ACRONYMDe kauwgomstudie
- hypothesisThe 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) studiedPostoperative ileus, Abdominal surgery, fast track care, Gum chewing
- Inclusion criteria1. Laparotomy by any indication;
2. Laparoscopic intestinal surgery.
- Exclusion criteria1. Age <18 years;
2. Emergency surgery;
3. Lacking informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2010
- planned closingdate1-dec-2012
- Target number of participants2000
- InterventionsGum chewing will be started directly postoperatively, 3 times a day for 30 minutes.
The control group will receive care as usual.
- Primary outcomeTime of hospital stay.
- Secondary outcome1. Time to first defecation;
2. Time to first flatus;
3. Complications.
- TimepointsStart directly postoperative, complications are reported untill 30 days postoperatively.
- Trial web sitewww.kauwgomstudie.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. N.J. Leersum, van
- CONTACT for SCIENTIFIC QUERIESDrs. N.J. Leersum, van
- Sponsor/Initiator Medical Center Haaglanden, Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Maatschap Heelkunde Medisch Centrum Haaglanden
- PublicationsN/A
- Brief summaryPostoperative 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
- RECORD7-nov-2010 - 12-mrt-2015


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