In the Netherlands, gum chewing has not been incorporated in the standard postoperative care after intra-abdominal surgery. Therefore a multi-center RCT was set up to evaluate the influence of gum chewing on the development of ileus. Our null…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
length of hospital stay
Secondary outcome
complications untill 30 days postoperatively
time to flatus
time to defaecation
time to tolerance of normal diet
postoperative pain
Background summary
Postoperative ileus is common after intra-abdominal surgery. It is
characterized by delayed passage of flatus and stool due to decreased bowel
activity. Prolonged delay in bowel function may lead to patient*s discomfort,
lengthened hospital stay and hospital-acquired infections . Recently, a
meta-analysis of 9 RCT*s on chewing gum after intra-abdominal surgery showed a
significant reduction in postoperative hospital stay (1.1 days), time to
passage of flatus and stool in the gum-chewing group. Also, the overall
infectious complications were reduced in this group , but data on this subject
were insufficiently reported. Although very promising, there is the possibility
of publication bias because the results were based exclusively on small and
heterogenic trials. Therefore a large well-designed randomized trial to compare
gum chewing with standard postoperative protocol is warranted.
Study objective
In the Netherlands, gum chewing has not been incorporated in the standard
postoperative care after intra-abdominal surgery. Therefore a multi-center RCT
was set up to evaluate the influence of gum chewing on the development of
ileus. Our null hypothesis was that standard care and postoperative gum chewing
were equal, the alternative stated that they would not.
The main objective was:
- What is the influence of gum chewing on the length of postoperative hospital
stay (in hours)?
The secondary objectives were:
- What is the influence of gum chewing on the complication rate until 30 days
postoperatively?
- What is the influence of gum chewing on time to flatus, defecation and diet
tolerance (in hours)?
- What is the influence of gum chewing on postoperative pain perception?
Study design
Multicenter, single-blinded, randomized controlled trial in a clinical setting.
Study burden and risks
Little burden.
No side effects were mentions in any of the RCT's on gum chewing
daily fill in short questionlist in diary
Postbus 9600
2300 RC Leiden
NL
Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
abdominal surgery
adult
Exclusion criteria
not able to obtain informed consent
children
acute surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30345.058.10 |