Early Phase 1
N=66
Effects of Rocking on Postoperative Ileus Duration Study
Abdominal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00494806 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator. — 3.16; 3.88 Days — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Rocking Chair Intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator. |
3.16; 3.88 | <0.05 sig |
Summary
Primary Objective:
1. Compare the duration of postoperative ileus (POI) duration (time to first flatus), subjective reports of surgical and gas pain, postoperative pain medication (total milligrams per 24 hours) and postoperative recovery time(length of stay) between two groups of abdominal surgery cancer patients receiving either standard postoperative care or standard care plus the rocking intervention.
Eligibility Criteria
Inclusion Criteria
- Post abdominal surgical cancer patient, undergoing abdominal surgery
- Over 21 years of age.
- Ambulatory.
- Cognitively intact.
- Scheduled to have epidural analgesia with fentanyl or dilaudid and/or patient controlled analgesia with morphine or dilaudid as their primary mode of postoperative pain control.
Exclusion Criteria
- Postoperative abdominal surgical cancer patient less than 21 years of age.
- Are not ambulatory.
- Are not cognitively intact.
- Have any of the following: severe neuromuscular disease, cardiovascular disease, pacemakers, inner-ear disturbances, known peripheral vascular disease that interferes with ambulation, are on sympathetic inhibitory or mood altering drugs. All patients will have epidural and/or patient controlled analgesia as their primary mode of postoperative pain control and those who do not will be excluded.
Data sourced from ClinicalTrials.gov (NCT00494806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.