Trial Outcomes & Findings for Effects of Rocking on Postoperative Ileus Duration Study (NCT NCT00494806)

NCT ID: NCT00494806

Last Updated: 2012-08-07

Results Overview

Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 66 participants
• Primary outcome timeframe: Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).
• Results posted on: 2012-08-07

Participant Flow

Recruitment Period: 11/18/05 through 03/05/07. All participants recruited at UT MD Anderson Cancer Center, prior to surgery during their preoperative evaluation in the Anesthesia Assessment and Preoperative centers.

There were no enrolled participates excluded from the trial prior to assignment to groups. All patients approached accepted participation into the study.

Participant milestones

Measure	Rocking Chair Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.	Standard Care Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
Overall Study STARTED	34	32
Overall Study COMPLETED	34	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Rocking on Postoperative Ileus Duration Study

Baseline characteristics by cohort

Measure	Rocking Chair n=34 Participants Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.	Standard Care n=32 Participants Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	56.2 years STANDARD_DEVIATION 10.1 • n=5 Participants	54.8 years STANDARD_DEVIATION 11.4 • n=7 Participants	55.6 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	32 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily from first day after surgical procedure to passage of first flatus (up to 5 - 7 days post surgery).

Population: Intention to treat (ITT) method was used.

Time from end of surgical procedure until passage of first postoperative flatus was used as an indicator for resolution of postoperatve ileus (POI).

Outcome measures

Measure	Rocking Chair n=34 Participants Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.	Standard Care n=32 Participants Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
Time to First Postoperative Flatus in Days Was the End of Postoperative Ileus (POI) Indicator.	3.16 Days Standard Deviation 0.86	3.88 Days Standard Deviation 0.80

Adverse Events

Rocking Chair

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert L. Massey, PhD, RN

MD Anderson Cancer Center

Phone: 713-792-3704

Email: rlmassey@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place